[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"brachytherapy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:brachytherapy":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,46,80,120,157,188,212,240,260],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100563397","alpha-radiation-emitters-device-dart-for-the-treatment-of-cutaneous-scc-for-immunocompromised-patients-100563397",false,"NCT06615635","Alpha Radiation Emitters Device (DaRT) for the Treatment of Cutaneous SCC for Immunocompromised Patients","A Pivotal, Single Arm, Open Label Clinical Study to Assess the Safety and Efficacy of Intratumoral Alpha DaRT224 for the Treatment of Immunocompromised Patients With Cutaneous Squamous Cell Carcinoma","DaRT","Inclusion Criteria:\n\n* 1\\. Patients with cutaneous SCC histologically confirmed 2. Histopathological confirmation within 6 months of enrollment provided no tumor treatment occurred between the biopsy and enrollment 3. Immunocompromised due to any primary or secondary immunodeficiencies Measurable disease according to RECIST v 1.1.\n\n  4\\. Patient able and willing to undergo multiple CT scans 5. Tumor size ≤7 cm, at the longest diameter. 6. Single lesion per subject. 7. Targeted lesion must be technically amenable for complete coverage (including margins) by the DaRT seeds. Targets will be deemed technically amenable for complete coverage if there are entry and exit vectors for placement that are not hindered by bone or major vessels or other vital organs (eg. eye) as decided by treating physician and sponsor.\n\n  8\\. Interstitial implant indication validated by multidisciplinary team. 9. ECOG Performance Status ≤2. 10. Life expectancy ≥12 months. 11. Subjects male\u002F female ≥18. 12. Willing and have the ability to provide signed Informed Consent. 13. Patients, male and female, with reproductive potential (including women who are menopausal for less than a year and not surgically sterilized), must practice acceptable effective methods of birth control, such as barrier methods, condom or diaphragm with spermicide or abstinence. Birth control should be continued for 1 year after the DaRT insertion visit.\n\n  14\\. Women with childbearing potential must provide a negative pregnancy test during the screening period and up to V1, prior to the DaRT insertion procedure.\n\n  15\\. Blood tests values:\n  * Platelets ≥100,000 mm3,\n  * Total bilirubin ≤ 1.5xULN,\n  * AST ≤2.5xULN,\n  * SGOT ≤2.5xULN,\n  * SGPT ≤2.5xULN,\n  * Alkaline Phosphatase ≤2.5xULN.\n  * Creatinine Clearance ≥30 ml\u002Fmin.\n  * INR or Prothrombin time ≤1.5xULN.\n\nExclusion Criteria:\n\n* 1\\. Distant or nodal metastatic disease (according to the TNM staging system - N+ or M1 patients are excluded).\n\n  2\\. T4 disease 3. extensive PNI 4. Previously untreated cutaneous SCC 5. Mucosal SCC. 6. Inability to fully cover the entire volume with DaRT seeds 7. Inability to place DaRT seeds into tumor due to inaccessibility by presence of bones or major vessels or vital organs 8. Inability or unwillingness to undergo multiple CT scans 9. Patients receiving any of the following within 4 weeks of enrollment:\n  1. Antineoplastic systemic chemotherapy or biological therapy\n  2. Immunotherapy\n  3. Investigational agents other than the study intervention\n  4. Radiation therapy\n  5. Live vaccines within 30 days prior to the first dose of trial treatment and while participating in the trial.\n\n     10\\. Longest tumor diameter \\>7 cm. 11. Tumor with keratoacanthoma histology. 12. Known hypersensitivity to any component of treatment. 13. Clinically significant cardiovascular disease e.g., cardiac failure of New York Heart Association class III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, history of myocardial infarction in the last 12 months.\n\n     14\\. Any medical or Psychiatric illness, which in the opinion of the investigator would compromise the patient's ability to tolerate treatment and to adhere to the clinical trial protocol.\n\n     15\\. Serious medical comorbidities that, in the opinion of the investigator, may affect subject compliance and\u002For interpretation of treatment safety or effectiveness.\n\n     16\\. High probability of protocol non-compliance (in opinion of investigator). 17. Volunteers participating in another interventional study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of DaRT.\n\n     18\\. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.\n\n     19\\. Patients do not agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry and for 1 year after the DaRT insertion visit.\n\n     20\\. Breastfeeding or pregnant women 21. Tattoos scars, body jewelry (e.g., nose rings) or other identifying marks which cannot be adequately hidden on digital photos or other identifying marks which cannot be adequately hidden on digital photos","ALL","18 Years",{"count":20,"type":21},28,"ESTIMATED","INTERVENTIONAL",[24],"NA","This is a multi-center clinical study enrolling up to 28 participants. The primary objectives are to determine the objective response rate (ORR) established by the confirmed best overall response (BOR) following intratumoral administration of DaRT - Diffusing Alpha-Emitters Radiation Therapy. Secondary objectives are to:\n\n1. Determine Progression Free Survival (PFS) up to 12 months after Alpha DaRT sources insertion.\n2. Assess Overall Survival (OS) of patients treated with DaRT up to 12 months.\n3. Assess Local control up to 12 months after DaRT insertion.",[27,28,29,30,31,32],"Squamous Cell Carcinoma","Alpha Radiation","Immunocompromised","Carcinoma, Squamous","Skin Cancer","Brachytherapy","RECRUITING","2026-06-15",{"date":36,"type":37},"2026-06-16","ACTUAL",{"date":39,"type":37},"2026-01-01",{"date":41,"type":21},"2026-12",{"name":43,"class":44},"Alpha Tau Medical LTD.","INDUSTRY",11,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":54,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":67,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":79},"100514523","phase-2-using-reiki-therapy-to-improve-symptoms-associated-with-brachytherapy-in-patients-with-gynecological-malignancies-100514523","NCT05979610","Using Reiki Therapy to Improve Symptoms Associated With Brachytherapy in Patients With Gynecological Malignancies","Reiki-Brachy: An Interventional Treatment Trial Using Reiki Therapy to Improve Symptoms Associated With Brachytherapy in Patients With Gynecological Malignancies","Reiki-Brachy","Inclusion Criteria:\n\n* Subject aged ≥ 18 years.\n* Pathologically confirmed malignancy of the endometrium, cervix, vagina or vulva.\n* Eligible to undergo brachytherapy treatment as an outpatient procedure.\n* Able to read and understand English and\u002For Spanish.\n* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.\n* Willing to participate in either the Reiki therapy or standard of care arm regardless of treatment assignment.\n\nExclusion Criteria:\n\n* Prior brachytherapy treatment for a gynecological malignancy.\n* Medical, psychiatric, cognitive, or other conditions that may compromise the subject's ability to understand the subject information, give informed consent, comply with the study protocol or complete the study.","FEMALE",{"count":56,"type":21},70,[58],"PHASE2","The goal of this open label, randomized, controlled clinical trial is to assess the benefits of providing Reiki therapy to subjects receiving their first brachytherapy treatment for gynecological malignancies.\n\nParticipants will either receive a session of Reiki therapy or usual care during the standard wait time between the placement of the brachytherapy device and brachytherapy treatment. Questionnaires will be administered at various time points on the day of the participant's first brachytherapy treatment as well as at the three month follow-up time point.\n\nResearchers will compare the intervention (Reiki therapy) and control (usual care) groups to assess the impact of the Reiki therapy on anxiety, pain, state anxiety, depression, and physiological measurements.",[61,32,62,63,64,65,66],"Gynecologic Neoplasm","Therapeutic Touch","Endometrial Cancer","Cervical Cancer","Vaginal Cancer","Vulvar Cancer",[68],"Reiki","2026-05-06",{"date":71,"type":37},"2026-05-11",{"date":73,"type":37},"2023-11-14",{"date":75,"type":21},"2027-06",{"name":77,"class":78},"University of Utah","OTHER",1,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":88,"minAge":18,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":22,"phases":91,"briefSummary":93,"conditions":94,"keywords":99,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":116,"leadSponsor":118,"locationsCount":79},"100625704","phase-2-pro-boost-n-prostate-first-versus-combined-prostate-and-nodal-dose-escalation-in-psma-pet-staged-node-positive-prostate-cancer-100625704","NCT07426094","PRO-BOOST-N: Prostate-First Versus Combined Prostate and Nodal Dose Escalation in PSMA PET-Staged Node-Positive Prostate Cancer","PRO-BOOST-N: A Randomized Phase II\u002FIII Trial Evaluating Prostate-First Versus Combined Prostate and Nodal Dose Escalation in PSMA PET-Staged Node-Positive Prostate Cancer Using an Ultrahypofractionated Whole-Pelvis Radiotherapy Platform","PRO-BOOST-N","Inclusion Criteria:\n\n* Histologically confirmed adenocarcinoma of the prostate.\n* Prostate cancer with clinically positive pelvic lymph nodes (cN1) without evidence of distant metastatic disease.\n* Pelvic lymph node involvement limited to regional pelvic lymph nodes (obturator, internal iliac, external iliac, presacral), as assessed by conventional imaging and\u002For PSMA PET\u002FCT.\n* No evidence of distant metastatic disease (M0), including absence of non-regional nodal, bone, or visceral metastases.\n* Candidate for definitive radiotherapy to the prostate and elective pelvic lymph nodes.\n* Planned treatment with androgen deprivation therapy with or without androgen receptor pathway inhibitors according to protocol.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.\n* Adequate organ function allowing delivery of protocol-defined radiotherapy and systemic therapy.\n* Age ≥18 years.\n* Ability to understand and willingness to sign a written informed consent.\n\nExclusion Criteria:\n\n* Evidence of distant metastatic disease (M1), including non-regional lymph node, bone, or visceral metastases.\n* Prior definitive local therapy for prostate cancer, including radical prostatectomy, whole-gland radiotherapy, or brachytherapy.\n* Prior pelvic radiotherapy for any indication that would overlap planned treatment fields.\n* Prior systemic therapy for prostate cancer other than protocol-allowed neoadjuvant androgen deprivation therapy.\n* History of castration-resistant prostate cancer.\n* Concurrent malignancy requiring active treatment, except non-melanoma skin cancer or other malignancies with negligible risk of interference with study outcomes.\n* Severe uncontrolled comorbidities that would preclude safe delivery of radiotherapy or systemic therapy.\n* Any condition that, in the opinion of the investigator, would interfere with patient safety or compliance with the study protocol.","MALE",{"count":90,"type":21},1600,[58,92],"PHASE3","Patients with prostate cancer and pelvic lymph node involvement (cN1M0) identified on PSMA PET imaging represent a biologically aggressive yet potentially curable disease population. Contemporary management relies on multimodality treatment combining definitive radiotherapy to the prostate and pelvic lymph nodes with long-term androgen deprivation therapy (ADT), often intensified with androgen receptor pathway inhibitors. Despite these advances, a substantial proportion of patients still develop distant metastatic disease, highlighting the need to optimize local-regional treatment strategies in the era of molecular imaging.\n\nThe introduction of PSMA PET has fundamentally altered staging accuracy in prostate cancer, enabling earlier and more precise detection of pelvic nodal disease. However, most existing evidence guiding radiotherapy dose prescription in node-positive prostate cancer originates from the pre-PSMA era. As a result, it remains unclear how best to integrate prostate-directed and nodal-directed dose escalation strategies when disease extent is defined by modern molecular imaging. In particular, it is unknown whether long-term disease control is primarily driven by durable intraprostatic tumor eradication, by aggressive treatment of involved lymph nodes, or by a combination of both.\n\nPRO-BOOST-N is a prospective, multicenter, randomized phase II\u002FIII clinical trial designed to address this critical evidence gap. The trial evaluates prostate-first versus combined prostate and nodal dose escalation strategies in patients with PSMA PET-staged node-positive (cN1M0) prostate cancer treated within a standardized ultrahypofractionated whole-pelvis radiotherapy framework. All enrolled patients indicated for definitive treatment undergo mandatory baseline PSMA PET\u002FCT to confirm pelvic lymph node involvement and exclude distant metastatic disease.\n\nAll patients receive a uniform radiotherapy backbone consisting of ultrahypofractionated whole-pelvis radiotherapy delivered in five fractions, combined with long-term ADT. Use of androgen receptor pathway inhibitors is permitted and encouraged according to contemporary clinical practice and local availability, ensuring the relevance of the trial to real-world treatment settings.\n\nUsing a 2×2 factorial randomized design, PRO-BOOST-N evaluates two independent treatment factors. The primary randomized comparison assesses whether ablative prostate dose escalation improves oncologic outcomes compared with contemporary SBRT-based definitive prostate radiotherapy without additional boost. Prostate dose escalation may be delivered using one of three protocol-defined modalities-high-dose-rate brachytherapy, low-dose-rate brachytherapy, or single-fraction SBRT-according to institutional expertise. This comparison directly tests the hypothesis that durable intraprostatic disease control is the dominant determinant of long-term systemic disease suppression in node-positive prostate cancer.\n\nThe key secondary, hierarchically tested comparison evaluates the role of nodal dose escalation by comparing two predefined dose levels delivered to PSMA PET-positive pelvic lymph nodes. These dose levels reflect intermediate versus higher nodal boost strategies based on biologically effective dose concepts specific to prostate cancer radiobiology. To ensure patient safety and protocol feasibility, organ-at-risk-driven nodal dose de-escalation is permitted within the higher-dose arm, without altering randomization assignment.\n\nThe primary endpoint of the trial is metastasis-free survival. Secondary endpoints include overall survival, radiographic progression-free survival assessed primarily using PSMA PET imaging, intraprostatic and regional nodal control, time to castration-resistant prostate cancer, time to next systemic therapy, treatment-related toxicity graded according to CTCAE version 5.0, and patient-reported outcomes assessing urinary, bowel, sexual, and global quality of life.\n\nBy prospectively and hierarchically evaluating prostate and nodal dose escalation strategies within a modern PSMA PET-guided and ultrahypofractionated radiotherapy platform, PRO-BOOST-N aims to define the optimal radiotherapy intensification approach for patients with node-positive prostate cancer. The results of this study are expected to directly inform clinical practice, guideline development, and future treatment individualization in the PSMA PET era.",[95,32,96,97,98],"Prostate Cancer","Stereotactic Body Radiation Therapy (SBRT)","Dose Escalation: Solid Tumors","Regionally Advanced Prostate Cancer",[100,101,102,32,103,104,105,106,107,108,109,110,111],"Radiotherapy","Stereotactic Body Radiotherapy","SBRT","High-Dose-Rate Brachytherapy","Low-Dose-Rate Brachytherapy","Dose Escalation","Ultrahypofractionation","PSMA PET","Prostate-Specific Membrane Antigen","Metastasis-Free Survival","Nodal metastases","Metastases","2026-03-19",{"date":114,"type":37},"2026-03-23",{"date":112,"type":37},{"date":117,"type":21},"2035-12-01",{"name":119,"class":78},"Affidea Nu-med Center of Oncological DIagnostics and Therapy",{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":126,"eligibilityCriteria":127,"healthyVolunteers":11,"sex":54,"minAge":18,"maxAge":4,"enrollmentInfo":128,"targetDuration":4,"studyType":130,"phases":4,"briefSummary":131,"conditions":132,"keywords":136,"overallStatus":147,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":79},"100612087","this-is-a-multicentre-international-study-evaluating-ct-based-igabt-with--without-either-trus-during-btpre-bt-mr-as-per-ibs-gecestro-abs-recommendations-for-target-contouring-as-an-alternative-to-mrigabt-for-cervical-cancer-from-implementation-perspectives-under-embrace-iiitriplet-impact-study-100612087","NCT07249021","This is a Multicentre International Study Evaluating CT-based IGABT With \u002F Without Either TRUS During BT\u002FPre BT MR as Per IBS-GECESTRO-ABS Recommendations for Target contouring-as an Alternative to MRIGABT for Cervical Cancer From Implementation Perspectives Under EMBRACE-III:TRIPLET IMPACT Study.","Integration of Multi-modality Imaging Protocols With emphAsis on CT in Image Guided Adaptive Brachytherapy (IGABT) for Cervical Cancer - EMBRACE III-IMPACT STUDY","IMPACT","Inclusion Criteria:\n\n1. Cancer of the uterine cervix considered suitable for curative treatment with definitive chemo radiotherapy including brachytherapy.\n2. Biopsy showing invasive squamous-cell carcinoma or adenocarcinoma or adeno - squamous cell carcinoma of the uterine cervix.\n3. FIGO (2018) stage IB2 to IVA\n4. Willingness to participate by signing informed consent form.\n\nExclusion Criteria:\n\n* Other previous or current primary malignancies except carcinoma in situ of the cervix.\n\n  * Metastatic Inguinal Nodes not amenable to radical radiation therapy\n  * Metastatic disease in para-aortic region beyond renal vessels\n  * Not eligible for concurrent cisplatin chemotherapy (creatinine clearance \\\u003C 50mg\u002Fml\u002Fmin)\n  * Previous pelvic or abdominal radiotherapy.\n  * Previous total or partial hysterectomy.\n  * Patients receiving BT alone.\n  * Patients receiving EBRT alone.\n  * Patients receiving any form of neoadjuvant anti-neoplastic therapy prior to definitive treatment or adjuvant therapy\n  * Active infection or severe medical condition which precludes radical chemoradiotherapy.\n  * Pregnant or lactating or childbearing potential without adequate contraception.",{"count":129,"type":21},1200,"OBSERVATIONAL","Title: Integration of Multi-modality Imaging Protocols with Emphasis on CT in Image-Guided Adaptive Brachytherapy (IGABT) for Cervical Cancer - EMBRACE III-TRIPLET : IMPACT Study Locally advanced cervical cancer (LACC) remains a major health challenge, particularly in low- and middle-income countries (LMICs), which account for the majority of global cases. The standard curative treatment involves a combination of external beam radiotherapy (EBRT) with concurrent chemotherapy, followed by brachytherapy (BT). Brachytherapy plays a crucial role in achieving high local control by delivering radiation directly to the tumour through internally placed radioactive sources.\n\nHistorically, BT dose prescription was based on two-dimensional (2D) X-ray images and defined anatomical \"points,\" achieving 5-year local control rates of 60-70%. Over the last decade, magnetic resonance imaging (MRI)-based image-guided adaptive brachytherapy (MR-IGABT) has transformed practice by enabling three-dimensional (3D) target-based dose prescription and adaptation to tumour regression. The landmark EMBRACE I study, involving over 1300 patients, demonstrated over 90% 5-year local control rates with MR-IGABT, establishing it as the international gold standard endorsed by NCG, ICRU, NCCN, and ESGO-ESTRO guidelines.\n\nHowever, MRI-based planning for IGABT remains logistically and financially challenging for many centres, especially in LMICs. CT and transrectal ultrasound (TRUS) have emerged as feasible alternatives, offering broader accessibility. Despite encouraging outcomes from smaller institutional studies, the lack of standardized and validated target delineation concepts for CT-IGABT has led to significant variability in clinical implementation. Recognizing this, the Indian Brachytherapy Society (IBS), American Brachytherapy Society (ABS), and GEC-ESTRO jointly published consensus recommendations in 2020 to standardize CT-IGABT practices across diverse clinical environments.\n\nAt Homi Bhabha Cancer Hospital and Research Centre, Visakhapatnam, our prior work (RetroLACER Study) demonstrated that CT-based IGABT can achieve outcomes comparable to MR-IGABT, highlighting its feasibility and potential for wider adoption. Building on this foundation, the EMBRACE III-IMPACT Study seeks to evaluate whether CT-IGABT can be systematically and uniformly implemented in a multi-centre setting and to benchmark clinical outcomes against the standards set by MR-IGABT.\n\nStudy Design:\n\nThis is a multicentre, prospective, observational study planned to include approximately 1200 participants with locally advanced cervical cancer. All participants will receive standard-of-care treatment, including EBRT, concurrent weekly cisplatin chemotherapy, and brachytherapy with image-guided planning.\n\nObjectives:\n\nTo assess the feasibility of implementing standardized CT-IGABT protocols across diverse clinical environments.\n\nTo evaluate local control, disease-free survival, and treatment-related toxicity outcomes for CT-IGABT.\n\nTo compare and benchmark CT-IGABT outcomes with established MR-IGABT benchmarks from prior international studies.\n\nParticipant Involvement:\n\nParticipants will undergo standard diagnostic imaging, EBRT with weekly cisplatin, and brachytherapy using CT-based planning. Imaging and treatment data will be collected, anonymized, and submitted to a central database for review. Regular follow-up visits will monitor tumour control and treatment-related side effects.\n\nBenefits:\n\nParticipants receive internationally standardized, quality-assured treatment protocols. Centres gain access to expert review and QA support from international collaborators, potentially improving treatment quality and outcomes.\n\nThe study supports global efforts to establish CT-IGABT as a cost-effective, accessible alternative to MRI-based IGABT, expanding equitable cancer care access.\n\nRisks:\n\nThe study is observational and involves standard treatment; therefore, risks and costs are comparable to routine cervical cancer care.\n\nConfidentiality and Ethics:\n\nAll data will be anonymized and handled in compliance with ethical and regulatory standards. Participant confidentiality will be strictly maintained. Written informed consent will be obtained before study participation.\n\nSignificance:\n\nBy validating standardised CT-based protocols and establishing outcome benchmarks, the study aims to facilitate widespread adoption of IGABT in resource-limited settings, ultimately improving treatment accessibility and survival outcomes.",[133,32,134,135],"Locally Advanced Cervical Cancer","CT","Transrectal Ultrasound",[137,138,139,140,141,142,143,144,145,146],"Cervical cancer","CT-guided brachytherapy","Image-Guided Adaptive Brachytherapy (IGABT)","Locally advanced cervical cancer","Implementation study","Resource-limited settings","Low- and middle-income countries (LMICs)","EMBRACE III","Trans-rectal ultrasound during BT","Pre BT MR Imaging","NOT_YET_RECRUITING","2025-11-21",{"date":150,"type":37},"2025-11-25",{"date":152,"type":21},"2025-11",{"date":154,"type":21},"2031-11",{"name":156,"class":78},"Homi Bhabha Cancer Hospital & Research Centre",{"id":158,"slug":159,"hasResults":11,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":163,"eligibilityCriteria":164,"healthyVolunteers":165,"sex":88,"minAge":18,"maxAge":166,"enrollmentInfo":167,"targetDuration":4,"studyType":22,"phases":169,"briefSummary":170,"conditions":171,"keywords":175,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":79},"100499706","ultra-hypofractionnated-radiotherapy-with-hdr-brachytherapy-boost-100499706","NCT05786742","Ultra Hypofractionnated Radiotherapy With HDR Brachytherapy Boost.","ULTRA-HYPO Fractionated (UHF) Compared to Moderate-HYPO Fractionated (MHF) Prostate IGRT With HDR Brachytherapy BOOST : A Phase 1-2 Study.","HYPO-5","Inclusion Criteria:\n\n* Biopsy proven Prostate adenocarcinoma\n* Stage T1c, T2 (Annex 2)\n* Stage Nx or N0\n* Stage Mx or M0\n* PSA \\\u003C 20ng\u002Fml\n* Gleason Score 6 or 7\n* Having the ability to sing a written consent\n\nExclusion Criteria:\n\n* Age \\\u003C 18ans\n* Clinical Stage T3 or T4\n* Stage N1\n* Stage M1\n* PSA \\> 20\n* Gleason Score 8 to 10\n* IPSS Score \\> 20 alpha-blocking medication.\n* Prior pelvic radiotherapy.\n* History of active collagenosis (Lupus, Sclerodermia, Dermatomyosis)\n* Past history of Inflammatory Bowell Disease\n* Bilateral hip prosthesis",true,"95 Years",{"count":168,"type":21},205,[24],"Phase 1-2 study, comparing ultra-hypofractionnated (UH) to a moderately hypofractionnated (MH) radiation therapy, with image guided HDR prostate brachytherapy. Using iso-equivalent doses, a non-inferiority analysis will be done in order to prove UH non-inferior to MH, toxicity wise. Acceptability, tolerability, acute and late toxicity will be reported. MRI visible dominant intra-prostatic lesion will be outlines and variability between radiation oncologists and radiologists will be reported. As secondary objective, biochemical and clinical failure free survival will be reported at 5 \\& 10 years.",[95,172,173,32,100,174],"Radiotherapy Side Effect","Hypofractionation","Localized Prostate Carcinoma",[176,177,178],"hypo fractionation","brachytherapy","Ultra Hypo fractionation","2025-09-07",{"date":181,"type":37},"2025-09-09",{"date":183,"type":37},"2014-04",{"date":185,"type":21},"2033-12",{"name":187,"class":78},"CHU de Quebec-Universite Laval",{"id":189,"slug":190,"hasResults":11,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":4,"eligibilityCriteria":194,"healthyVolunteers":11,"sex":88,"minAge":18,"maxAge":195,"enrollmentInfo":196,"targetDuration":4,"studyType":130,"phases":4,"briefSummary":198,"conditions":199,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":79},"100591595","high-dose-rate-hdr-brachytherapy-salvage-after-prostatectomy-100591595","NCT06982469","High Dose Rate (HDR) Brachytherapy Salvage After Prostatectomy","Magnetic Resonance Imaging (MRI)\u002F Positron Emission Tomography (PET) Prostate-specific Membrane Antigen (PSMA) -Based Phase I-II Study of Salvage HDR Brachytherapy and External Beam Irradiation In Isolated Tumor Bed Relapses After Radical Prostatectomy","Inclusion Criteria:\n\n* Patients with increasing PSA after RP and clinical evidence of PET PSMA\u002FCholine+ and MRI+ isolated prostatic bed relapse (IPBR) that is implantable via transperineal route . The IPBR should be visible on TRUS imaging to allow proper implant placement.\n* Pathological confirmation is advised in all cases but it is not mandatory .\n* Brachytherapy MRI-based dosimetry\n* Patient written Informed Consent of the Institutional Review Board-approved protocol that discloses the investigational nature of the treatment as well as the available standard treatment options.\n\nExclusion Criteria:\n\n* Distant Metastases\n* Isolated nodal relapses\n* Prior Irradiation to the IPBR area\n* Multicentric IPBRs\n* Life expectancy of less than 5 years or inability to tolerate and comply with an HDR procedure","80 Years",{"count":197,"type":21},20,"The goal of this observational study is to learn about the long-term effects of HDR Brachytherapy in men with isolated local relapses after radical prostatectomy. The main question it aims to answer is:\n\nDoes HDR Brachytherapy increase control rates and decreases complications compared with conventional External Irradiation?\n\nParticipants will be asked to receive HDR brachytherapy as part of their regular medical care for isolated local relapses after radical prostatectomy",[95,200,201,202,32],"Prostatectomy","Local Recurrence of Malignant Tumor of Prostate","Radiotherapy; Complications","2025-06-18",{"date":205,"type":37},"2025-06-19",{"date":207,"type":37},"2020-05-05",{"date":209,"type":21},"2030-05-01",{"name":211,"class":78},"Clinica Universidad de Navarra, Universidad de Navarra",{"id":213,"slug":214,"hasResults":11,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":218,"eligibilityCriteria":219,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":220,"targetDuration":4,"studyType":22,"phases":222,"briefSummary":223,"conditions":224,"keywords":227,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":79},"100507947","phase-2-brachytherapy-iodine-125-seeds-and-fluzoparib-combination-therapy-for-advanced-unresectable-soft-tissue-sarcoma-100507947","NCT05894018","Brachytherapy (Iodine-125 Seeds) and Fluzoparib Combination Therapy for Advanced Unresectable Soft Tissue Sarcoma","A Phase II Clinical Trial Evaluating the Safety and Efficacy of Radioactive Particle and Fluzoparib Combination Therapy in the Treatment of Advanced Unresectable Soft Tissue Sarcoma","RAFAS-001","Inclusion Criteria:\n\n1. Voluntarily agree to participate in this study and sign an informed consent form;\n2. Age ≥18 (calculated on the day of signing the informed consent), regardless of gender;\n3. Pathologically confirmed soft tissue sarcoma, with at least one measurable lesion according to RECIST 1.1 criteria on CT or MRI scan, within 28 days before the first study treatment (the longest diameter of the lesion ≥10 mm or the short diameter of swollen lymph node ≥15 mm);\n4. A single lesion ≤5cm and no more than 5 lesions;\n5. Received systemic therapy (such as standard treatment: doxorubicin plus ifosfamide) ± surgical resection as the first-line treatment;\n6. Able to swallow pills normally;\n7. ECOG performance status of 0-1;\n8. Expected survival period ≥12 weeks;\n9. Normal function of important organs, including:\n\nAbsolute neutrophil count ≥1.5×109\u002FL;Platelets ≥80×109\u002FL;Hemoglobin ≥90 g\u002FL;Serum albumin ≥28 g\u002FL;Thyroid-stimulating hormone (TSH) ≤1×ULN (if abnormal, FT3 and FT4 levels should be examined simultaneously, and if FT3 and FT4 levels are normal, patients can be included);Bilirubin ≤1.5×ULN (within 7 days before the first treatment);ALT and AST ≤3×ULN (within 7 days before the first treatment);Alkaline phosphatase (AKP) ≤2.5×ULN;Serum creatinine ≤1.5×ULN; Non-surgically sterilized or fertile female patients need to use a medically recognized contraceptive measure (such as an intrauterine device, birth control pills, or condoms) during the study treatment period and within 3 months after the end of the study treatment. Fertile female patients who are not surgically sterilized must have a negative serum or urine HCG test within 72 hours before study enrollment and must not be breastfeeding. Male patients with fertile female partners should also use effective contraception during the trial period and for 3 months after the last dose of the study treatment.\n\nExclusion Criteria:\n\n1. Clinical cardiac symptoms or disease that were not well controlled, such as: NYHA class 2 or higher heart failure, unstable angina, myocardial infarction within 1 year, clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention, QTc\\>450ms (men); QTc\\>470ms (women);\n2. Coagulation abnormal function (INR\\>2.0, PT\\>16s), bleeding tendency or on thrombolytic or anticoagulant therapy, prophylactic use of low-dose aspirin, low-molecular heparin allowed;\n3. Clinically significant bleeding symptoms or clear bleeding tendency within 3 months prior to enrollment, such as daily cough\u002Fhemoptysis of 2.5 ml or more, gastrointestinal bleeding, esophagogastric fundic varices with bleeding risk ;\n4. Arterial\u002Fvenous thrombotic events such as cerebrovascular accidents (including temporary ischemic attack, cerebral hemorrhage, and cerebrovascular disease) that occurred within 6 months prior to enrollment. ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism;\n5. Known hereditary or acquired bleeding and thrombotic predisposition (e.g., hemophiliacs, coagulation disorders, thrombocytopenia, etc.);\n6. Patients who have received prior chemotherapy, surgery, less than 4 weeks after completion of treatment (last dose) and prior to study dosing; or patients who have not recovered from adverse events (other than alopecia) caused by prior treatment to ≤ CTCAE grade 1;\n7. Patients with active infection, unexplained fever ≥38.5°C within 7 days prior to dosing, or white blood cell count \\>15×109\u002FL at baseline;\n8. Patients with other malignancies (except cured basal cell carcinoma of the skin and cervical carcinoma in situ) within the previous 3 years or concurrently;\n9. Patients with established bone metastases who have received, within 4 weeks prior to enrollment in the study;\n10. Prior external radiotherapy to the lesion;\n11. Pregnant or breastfeeding women, or women of childbearing age who do not wish to use contraception;\n12. Patients who, in the judgment of the investigator, have other factors that may affect the outcome of the study or force the termination of the study, such as alcoholism, substance abuse, other serious illnesses (including mental illness) requiring comorbid treatment, severe abnormal laboratory tests, accompanied by family or social factors that would affect the safety of the patient.",{"count":221,"type":21},32,[58],"To evaluate the effectiveness and safety of radioactive particles in combination with the PARP inhibitor fluzoparib in the treatment of advanced inoperable soft tissue sarcoma.",[225,32,226],"Sarcoma,Soft Tissue","Poly(ADP-ribose) Polymerase Inhibitors",[228,229,230],"Fluzoparib","Radioactive particles","Iodine-125 seed","2025-05-12",{"date":233,"type":37},"2025-05-13",{"date":235,"type":37},"2023-06-29",{"date":237,"type":21},"2028-12-31",{"name":239,"class":78},"Fujun Zhang",{"id":241,"slug":242,"hasResults":11,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":4,"eligibilityCriteria":246,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":247,"targetDuration":4,"studyType":130,"phases":4,"briefSummary":249,"conditions":250,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":79},"100534571","in-vivo-treatment-verification-of-brachytherapy-100534571","NCT06240559","In Vivo Treatment Verification of Brachytherapy","In-vivo Treatment Verification for HDR Brachytherapy Patients Using an External Imaging Panel","Inclusion Criteria:\n\n* Treatment site Gynaecology (Endometrium\u002FCervix) and prostate\n* Treatment: HDR Brachytherapy\n* Patient will be treated on CT Couch\n* Mentally competent patient\n\nExclusion Criteria:\n\n* Incapacitated patient",{"count":248,"type":21},100,"To acquire data during High Dose Rate (HDR) brachytherapy treatments aiming to track the brachytherapy source inside the patient verifying the delivery of the treatment plan.\n\nMedical images (CT,MRI and US) combined with software developed by the investigator will be employed to predict the response of the Investigational product during the treatment and will be used as reference.The IP will be placed on the side of the treatment table and will acquire data during the whole treatment, which will be compared against information derived from the treatment plan. The IP based method can detect errors and information about motion and treatment uncertainties that are not currently available.",[32],"2025-05-06",{"date":253,"type":37},"2025-05-09",{"date":255,"type":37},"2024-02-29",{"date":257,"type":21},"2026-02",{"name":259,"class":78},"Maastricht Radiation Oncology",{"id":261,"slug":262,"hasResults":11,"nctId":263,"briefTitle":264,"officialTitle":265,"acronym":266,"eligibilityCriteria":267,"healthyVolunteers":11,"sex":54,"minAge":18,"maxAge":195,"enrollmentInfo":268,"targetDuration":4,"studyType":130,"phases":4,"briefSummary":270,"conditions":271,"keywords":275,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":79},"100457918","retrospective-study-of-brachytherapy-100457918","NCT05242861","Retrospective Study of Brachytherapy","A Retrospective Study of Brachytherapy in Gynecological Cancers","RetroBT","Inclusion Criteria:\n\n* 18 - 80 female\n* Underwent brachytherapy\n* With gynecological cancer\n\nExclusion Criteria:\n\n* Refusal to enter this trial",{"count":269,"type":21},300,"Brachytherapy for gynecological cancers will be studied retrospectively.",[32,272,273,66,65,274,61],"Uterine Cervical Neoplasms","Uterine Neoplasms","Ovarian Neoplasms",[32,64,63,65,66,276,277],"Image Guided","3D Print","2022-02-06",{"date":280,"type":37},"2022-02-16",{"date":282,"type":21},"2022-02-20",{"date":284,"type":21},"2027-12-31",{"name":286,"class":78},"Zhejiang Cancer Hospital"]