[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"oligoprogression\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:oligoprogression":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,43,69,98,127,152],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100499528","single-vs-multiple-fraction-trial-of-stereotactic-ablative-radiotherapy-for-comprehensive-treatment-of-oligometastasesprogression-100499528",false,"NCT05784428","Single vs. Multiple Fraction Trial of Stereotactic Ablative Radiotherapy for Comprehensive Treatment of Oligometastases\u002FProgression","Single vs. Multiple Fraction Non-Inferiority Trial of Stereotactic Ablative Radiotherapy for the Comprehensive Treatment of Oligo-metastases\u002FProgression: SIMPLIFY-SABR-COMET","Inclusion Criteria:\n\n* 1-5 current oligometastatic or oligo-progressive lesions\n* Age 18 years or older\n* Able to provide informed consent\n* Able to complete electronic entry of patient reported outcomes and questionnaires independently or with assistance from a caregiver\u002Ffamily\u002Ffriend\u002Fresearch staff using electronic methods after providing consent to email use.\n* Life expectancy \\> 6 months\n* Histologically confirmed malignancy with metastatic disease detected on imaging. Biopsy of metastasis is preferred, but not required.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Controlled primary tumor: defined as at least 3 months since original tumor treated radically, with no progression at primary site (can be considered controlled if no evidence of the primary tumour on imaging \\[e.g. primary unknown\\])\n* A history and physical examination, including ECOG performance status, performed within 6 weeks prior to enrollment\n* Patient has had a CT chest, abdomen and pelvis or PET-CT within 10 weeks prior to enrollment, and within 13 weeks prior to treatment\n* Patient has had a nuclear bone scan (if no positron emission tomography-computed tomography \\[PET-CT\\]) within 10 weeks prior to enrollment, and within 13 weeks prior to treatment\n* Patient has had CT or MRI brain imaging if primary has a propensity for central nervous system metastases (if deemed appropriate by the treating investigator) within 10 weeks prior to enrollment, and within 13 weeks prior to treatment.\n* For patients with known spine metastases, patient has had MRI spine imaging within 10 weeks prior to enrollment, and with 13 weeks prior to treatment.\n* If solitary lung nodule for which biopsy is unsuccessful or not possible, patient has had an FDG (fluorodeoxyglucose) PET scan or CT (chest, abdomen, pelvis) and bone scan within 10 weeks prior to enrollment, and within 13 weeks prior to treatment\n* If colorectal primary with rising Carcinoembryonic antigen (CEA), but equivocal imaging, patient has had an FDG PET scan within 10 weeks prior to enrollment, and within 13 weeks prior to treatment\n* Patient is judged able to:\n\n  * Maintain a stable position during therapy\n  * Tolerate immobilization device(s) that may be required to deliver SABR safely\n* Negative pregnancy test for People of Child-Bearing Potential (POCBP) within 4 weeks of RT start date\n\nExclusion Criteria:\n\n* Uncontrolled concurrent malignant cancer\n* Lesion in femoral bone requiring surgical fixation\n* No chemotherapy agents (cytotoxic, or molecularly targeted agents) will be used within the period of time commencing 1 week prior to radiation, lasting until 1 week after the last fraction. See section 5.3.3 regarding this criterion.\n* Serious medical comorbidities precluding radiotherapy. These include interstitial lung disease in patients requiring thoracic radiation, Crohn's disease in patients where the gastrointestinal (GI) tract will receive radiotherapy, and connective tissue disorders such as lupus or scleroderma.\n* Substantial overlap with a previously treated radiation volume. Prior radiotherapy in general is allowed, as long as the composite plan meets dose constraints herein. For patients treated with radiation previously, similar biological effective dose calculations should be used to equate previous doses to the tolerance doses listed below. All such cases should be discussed with the local and study principal investigators (PIs).\n* Current malignant pleural effusion\n* Liver metastases located in the \"Biliary no fly zone\" defined for this trial as common biliary track, cystic duct and distal branches (1 cm) + 5 mm.\n* Inability to treat all sites of oligometastatic or oligoprogressive disease\n* Presence of brain metastases as the sole site of disease\n* Maximum size of 5 cm for lesions outside the brain, except:\n\n  * Bone metastases over 5 cm may be included, if in the opinion of the local PI it can be treated safely (e.g. rib, scapula, pelvis)\n* Any brain metastasis \\> 3.5 cm in size or a total volume of brain metastases greater than 30 cc is excluded\n* Clinical or radiologic evidence of spinal cord compression. Patients can be eligible if surgical resection has been performed\n* Patients with spine instability as judged by a Spinal Instability Neoplastic Score (SINS) of \\>12\n* Dominant brain metastasis requiring surgical decompression\n* Surgical resection of all metastases (i.e. no lesion available to be treated with SABR)\n* Complete response to systemic therapy, defined as the absence of visible disease on imaging\n* Pregnant or breast feeding","ALL","18 Years",{"count":19,"type":20},598,"ESTIMATED","INTERVENTIONAL",[23],"NA","Stereotactic Ablative Radiotherapy (SABR) is a modern RT technique that delivers high doses of radiation to small tumor targets using highly conformal techniques, while trying to avoid healthy tissues and organs. However, SABR treatment requires increased planning, treatment time, cost and potential for higher toxicity due to the higher dose. The purpose of this study is to compare single fraction (SF) SABR vs. multiple fraction (MF) SABR in regards to toxicities, progression-free survival, quality of life (QoL), and cost-effectiveness. In a subset of patients, we will also compare patient QoL, hospitalization rates, and cost-effectiveness between patients who complete QoL questionnaires, record symptoms and receive healthcare provider-guided intervention vs. patients who complete QoL questionnaires only.",[26,27,28,29],"Oligometastatic Disease","Oligoprogression","Toxicity Due to Radiotherapy","Quality of Life","RECRUITING","2026-06-23",{"date":33,"type":34},"2026-06-25","ACTUAL",{"date":36,"type":34},"2025-04-16",{"date":38,"type":20},"2035-05-30",{"name":40,"class":41},"Robert Olson","OTHER",14,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":68},"100447154","stereotactic-radiotherapy-in-oligometastatic-brain-disease-a-randomised-phase-iii-study-comparing-hypofractionated-stereotactic-radiation-therapy-310-gy-to-the-historical-single-dose-radiosurgery-120-to-25-gy-with-medico-economic-evaluation-100447154","NCT05102747","Stereotactic Radiotherapy in Oligometastatic Brain Disease: a Randomised Phase III Study Comparing Hypofractionated Stereotactic Radiation Therapy (3*10 Gy) to the Historical Single-dose Radiosurgery (1*20 to 25 Gy) With Medico-economic Evaluation.","OligoBM-01","Inclusion Criteria:\n\n* Patients aged ≥ 18 years\n* WHO performance status 0 or 1;\n* Patient eligible for SRT after a multidisciplinary committee decision; Patient with BMs from radioresistant cancer (renal cell carcinoma, sarcoma, melanoma) is eligible\n* Patient having up to 5 BM of solid tumours with an histologically proven diagnoses; patients who have had a metastasectomy and having 1 to 4 BM lesions is eligible (ANOCEF recommendations); post-operative cavity must be treated by radiosurgery according to local procedures with respect of non-inclusion criteria\\* (cavity will not be analyzed for efficacy)\n* Presence of at least one and no more than 5 target lesions for SRT, measuring between 10 and 25 mm. In the event of synchronous BM, lesions measuring less than 10mm or more than 25mm (1 to 4 lesions) will be treated at the discretion of the investigator\n* Max cumulative GTV of 30cm3\n* Normal complete blood count (CBC)\n* Absence of bleeding BM or meningeal carcinomatosis;\n* Symptomatic BM are allowed\n* DS-GPA score:\n\n  * Renal cancer: DS-GPA 2,5 or more\n  * Breast cancer: DS-GPA 2,5 or more\n  * Melanoma: DS-GPA 1.5 or more\n  * Gastro-instestinal (GI) cancer: DSGPA 3 or more\n  * Adenocarcinoma lung cancer: DS-GPA 2 or more (DS-GPAmol)\n  * Squamous lung cancer : DS-GPA 2,5 or more (DS-GPAmol)\n  * For cancers where the DS-GPA score is not applicable, the patient is eligible if eligibility criteria are met\n* Patient with no concomitant systemic treatment; in case of ongoing systemic treatment, wash out period of 3-7 days before and after SRT, depending of drug and at the discretion of investigator;\n* Patient sufficiently cooperating to perform the treatment with the use of a thermoformed mask;\n* Patient whose neuropsychological abilities allow to follow the requirements of the protocol;\n* Female with childbearing potential must use adequate contraception\n* Signed informed consent formOligoBM-01 Trial - ID-RCB number: 2021-A01622-39 - version 3.1 dated from 2023-06-22 Page 9 of 51\n* Patients affiliated to the social security system\n\nExclusion Criteria:\n\n* Patients with current or past history small cell lung cancer, germ-cell tumours, lymphoma, leukemia and multiple myeloma within the last 5 years;\n* Patients with metastases in the brain stem, or within 1 cm of the optic apparatus;\n* Patients with an associated neurodegenerative disease;\n* Any symptoms not attributable to BM or cancer disease requiring long term corticosteroid use (regardless of dose);\n* Contraindication to perform the brain MRI or gadolinium or iodinated contrast;\n* Known hypersensitivity to the contrast product or to any their excipients\n* Patients with previous brain stereotactic irradiation\n* Whole brain irradiation history;\n* Haemorrhagic metastasis;\n* Ongoing anti angiogenic treatment (treatment should be held 3-7 days before irradiation and re-initiated 3-7 days after irradiation for patient to be eligible);\n* Patients with too close brain lesions for whom a treatment plan on one target metastasis delivers a dose \\> 5 Gy on other concomitant metastasis ;\n* Patient deprived of liberty or under guardianship;\n* Known pregnancy or breastfeeding\n* Any geographical conditions, social and associated psychopathology that may compromise the patient's ability to participate in the study;\n* Participation in a therapeutic trial for less than 30 days.\n* Patient deprived of freedom or under guardianship",{"count":51,"type":20},504,[23],"Brain metastases (BM) are a common systemic cancer manifestation which incidence increases. Therapeutic options include whole-brain radiotherapy (WBRT), surgery, and stereotactic radiosurgery (SRS). The concept of \"oligometastatic\" cerebral disease (oligoBM) has emerged and led to consider alternative approaches. The main challenge is to preserve neurological function and independence the longest as possible.\n\nStereotactic radiotherapy (SRT) has emerged as an alternative treatment modality for selected oligoBM patients. It allows to achieve the balance of tumour destruction and normal tissue preservation by precisely and accurately delivering a very high dose of radiation in one (SRS) or a few (HSRT) fractions to a limited, well-defined volume. However, no standard exists for decision-making between SRS and HSRT and this important question is being discussed in the recent literature.\n\nHSRT appears particularly interesting, assuming the patient convenience of few fractions, the normal tissue sparing achieved through focal irradiation, and the improved normal tissue tolerance of high dose radiation through fractionation.\n\nCommon adverse effects of SRT are rare but can occasionally be serious, notably radionecrosis that may induce neurological deficits in patients. Although SRS is often less well-tolerated, it remains the mainstay of treatment.\n\nTo investigators knowledge, SRS and HSRT have not been prospectively compared.",[55,27],"Brain Metastasis",[57,58],"Stereotactic radiosurgery","Fractionated stereotactic radiotherapy","2026-01-26",{"date":61,"type":34},"2026-01-27",{"date":63,"type":34},"2023-01-12",{"date":65,"type":20},"2031-01",{"name":67,"class":41},"Centre Francois Baclesse",15,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":76,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":21,"phases":79,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":97},"100586713","stereotactic-radiotherapy-versus-palliative-conventional-radiotherapy-for-oligoprogressive-metastatic-cancers-100586713","NCT06918951","Stereotactic Radiotherapy Versus Palliative Conventional Radiotherapy for Oligoprogressive Metastatic Cancers","Stereotactic Radiotherapy Versus Palliative Conventional Radiotherapy for Oligoprogressive Metastatic Cancers: A Double-Blind Randomized Phase III Trial","Inclusion Criteria:\n\n1. Age 19 or older\n2. Able to provide informed consent\n3. Histologically confirmed solid malignancy (excluding lymphoma or myeloma) with metastatic disease detected on imaging\n4. Biopsy of metastasis at some time prior to enrollment is preferred, but not required\n5. ECOG performance status 0-2\n6. Life expectancy ≥ 6 months\n7. Progression meeting RECIST criteria in up to 5 individual lesions. Progression may be defined as:\n\n   1. Progression of an individual metastasis according to RECIST 1.1 criteria (≥ 20% enlargement of the tumour vs. baseline or nadir, taking as reference the smallest diameter seen prior to starting or during systemic therapy, and associated with a 5 mm minimum increase in size) OR\n   2. Unambiguous development of a new metastatic lesion at least 5 mm in size OR\n   3. Progressive enlargement of a known metastasis on 2 consecutive imaging studies 2-3 months apart with a minimum 5 mm increase in size from baseline.\n   4. A progressing primary tumor is eligible as per the criteria above\n8. If the participant is on systemic therapy at the time of oligoprogression:\n\n   The most recent systemic therapy agent must have been delivered for a total of at least 3 months, with an initial partial response (PR), complete response (CR) or stable disease (SD) prior to the development of oligoprogressive lesions\n9. If the participant is not on systemic therapy at the time of oligoprogression:\n\n   (i.e., \"oligorecurrence\"(1), however, included as \"oligoprogression\" for the purpose of this study protocol):\n10. There must be PR, CR or SD persisting for at least 3 months prior to the development of oligoprogressive lesions\n11. Participants who are not on systemic therapy at the time of oligoprogression must have other site(s) of disease (metastases or primary tumor) that are stable or resolved and have not received definitive treatment (inclusive of surgery, radical doses of radiotherapy including SABR, or ablation) and are not going to receive SABR.\n12. All sites of oligoprogression can be safely treated\n13. Restaging completed within 12 weeks prior to randomization (see section 5.1)\n14. Negative urine pregnancy test for People of Child-Bearing Potential (POCBP) within 4 weeks of radiotherapy start date.\n\nExclusion Criteria:\n\n1. Serious medical comorbidities precluding radiotherapy. These include ataxia-telangiectasia or scleroderma, Crohn's disease in participants where the gastrointestinal (GI) tract will receive radiotherapy, or ulcerative colitis where the bowel will receive radiotherapy.\n\n   a. For participants with oligoprogressive lesions in the lung or thorax, this includes interstitial lung disease.\n2. Substantial overlap with a previously treated radiation volume. Prior radiotherapy in general is allowed, provided that the composite plan meets dose constraints herein. For participants treated with radiation previously, biological effective dose calculations should be used to equate previous doses to the tolerance doses listed in Appendix 1. A tissue recovery factor may be used in these calculations and if so, must be clearly documented, along with elapsed time from previous radiotherapy, and approved by the local principal investigator.\n3. Current malignant pleural effusion, malignant ascites, or leptomeningeal disease\n4. Inability to treat all sites of oligoprogressive disease\n5. Liver metastases requiring placement of fiducial markers for SABR, as this would compromise successful blinding. Liver metastases are eligible if: 1) they are treated at an institution that offers liver SABR without fiducial markers or 2) pre-existing markers such as surgical clips or calcifications would serve as fiducial markers\n6. Brain metastasis \\> 3.5 cm in size or a total volume of brain metastases greater than 30 cc.\n7. Clinical or radiologic evidence of spinal cord compression. Participants can be eligible if surgical resection has been performed.\n8. Participants with spine instability as judged by a Spinal Instability Neoplastic Score (SINS) of \\>12.\n9. Dominant brain metastasis requiring surgical decompression\n10. For participants with liver metastases; moderate\u002Fsevere liver dysfunction (Child Pugh B or C)\n11. Liver metastases located in the \"Biliary no fly zone\" defined for this trial as common biliary track, cystic duct and distal branches (1 cm) + 5 mm\n12. Surgical resection of all oligoprogression metastases (i.e. no lesion available to be treated with SABR)\n13. Pregnant or lactating individuals","19 Years",{"count":78,"type":20},194,[23],"STOP-2 is a phase III multi-institutional double-blind randomized trial. 194 participants will be enrolled in this trial. Participants will be randomized in a 1:1 ratio between the Control Arm vs. the Experimental Arm.\n\nParticipants, enrolling oncologists, and the statistician will be blinded to trial arm assignment.\n\nIn the control arm, radiotherapy will consist of 8 Gy in 1 fraction to all sites of oligoprogression, and the experimental arm will consist of SABR treatment to all sites of oligoprogression.\n\nPrimary Objectives\n\n* To assess the impact of SABR, compared to palliative conventional radiotherapy, on Progression-free survival on next line systemic therapy (PFS-NEST), oncologic outcomes, and Quality of Life (QOL) in participants with 1-5 oligoprogressing lesions.\n* To assess the feasibility of the clinical trial in terms of accrual and success of double-blinding.\n\nSecondary Objectives\n\n* To evaluate and compare the impact of SABR and palliative radiation therapy on the overall survival (OS), progression free survival (PFS), polymetastatic progression-free survival (PPFS);\n* To assess and compare the proportion of participants receiving additional radiation therapy and other metastasis-directed interventions during follow-up between both arms;\n* To compare the impact of SABR and palliative radiation therapy on the time to initiation of the next line of systemic therapy;\n* To identify and compare the anatomic sites of disease progression between the experimental (SABR) and control (palliative radiation) arms;\n* To compare the treatment related toxicity among participants in each arm;\n* To evaluate and compare the quality of life among participants in each arm;\n* To assess the cost-effectiveness of the experimental arm compared to the control arm.",[27,26,82],"OligoProgressive Metastatic Disease",[84,85,86,87],"SABR","Radiotherapy","Quality of life","Metastatic Cancer","2025-12-08",{"date":90,"type":34},"2025-12-15",{"date":92,"type":34},"2025-12-04",{"date":94,"type":20},"2033-06-01",{"name":96,"class":41},"British Columbia Cancer Agency",1,{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":106,"targetDuration":108,"studyType":109,"phases":4,"briefSummary":110,"conditions":111,"keywords":116,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":97},"100602271","smc-radiation-oncology-sabr-cohort-for-oligometastasis-100602271","NCT07121335","SMC Radiation Oncology SABR Cohort for Oligometastasis","Cohort Study for Local Stereotactic Body Radiotherapy in Patients With Oligometastatic or Oligoprogressive Cancer","SABR-OMOP","Inclusion Criteria:\n\n* Performance status (ECOG PS) 0-2\n* Diagnosed with metastatic disease\n* Confirmed to have oligometastatic\u002Foligoprogressive cancer on imaging performed within 4 weeks (up to 5 lesions)\n\nExclusion Criteria:\n\n* Patient with a history of prior radiotherapy to the site planned for SABR\n* Patients with concomitant brain metastases",{"count":107,"type":20},60,"3 Years","OBSERVATIONAL","The goal of this observational study is to evaluate the efficacy and safety of stereotactic body radiotherapy (SABR) in patients with oligometastatic or oligoprogressive cancer.\n\nThe main questions it aims to answer are:\n\n1. oncologic outcomes (progression-free survival, local failure rate),\n2. patient-reported outcomes,\n3. physician-assessed toxicity, and\n4. dynamics of circulating tumor DNA (ctDNA) for biomarker analysis.",[112,113,27,114,115],"Stereotactic Body Radiation Therapy (SBRT)","Oligometastasis","ctDNA","Patient-Reported Outcomes (PRO)",[117,113,27,114],"Stereotactic body radiotherapy","2025-08-08",{"date":120,"type":34},"2025-08-13",{"date":122,"type":34},"2025-05-01",{"date":124,"type":20},"2030-03-31",{"name":126,"class":41},"Samsung Medical Center",{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":4,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":134,"enrollmentInfo":135,"targetDuration":4,"studyType":21,"phases":137,"briefSummary":139,"conditions":140,"keywords":4,"overallStatus":142,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":4},"100561626","phase-2-second-line-systemic-therapy-combined-with-sbrt-for-hcc-with-oligoprogression-after-standard-first-line-systemic-treatment-100561626","NCT06592612","Second-line Systemic Therapy Combined with SBRT for HCC with Oligoprogression After Standard First-line Systemic Treatment","Second-line Systemic Therapy with or Without Stereotactic Body Radiotherapy (SBRT) for Oligoprogressive Hepatocellular Carcinoma After Standard First-line Systemic Treatment: a Prospective, Randomized, Phase II Study","Inclusion Criteria:\n\n1. KPS (Karnofsky Performance Status) score ≥ 80;\n2. Pathologically, or clinically diagnosed hepatocellular carcinoma (HCC) based on the \\" Chinese Guidelines for the Diagnosis and Treatment of Hepatocellular Carcinoma (2024 Edition) \\";\n3. Patients with oligoprogression after first-line standard systemic therapy (bevacizumab combined with atezolizumab\u002Fsintilimab or lenvatinib with or without PD-1 antibody).\n\n   Definition of oligoprogression: 1-5 progressive lesions involving 1-3 organs\u002Fsystems, including: (1)The maximum diameter of a target lesion, as assessed by RECIST 1.1 criteria, increases by more than 20% compared to baseline, with an absolute increase of \\>5 mm; (2) The maximum diameter of a target lesion increases by more than 20% compared to baseline on two consecutive evaluations (at least 2 months apart), regardless of whether the absolute increase is \\>5 mm; (3) The appearance of a new intrahepatic lesion ≥1 cm with typical imaging characteristics of HCC; 4) The appearance of any new extrahepatic lesion or bone metastasis, regardless of size; 5) Any new FDG-avid lesion confirmed by PET\u002FCT, or an increase in SUVmax of more than 30% with an absolute increase of \\>0.8 SUV; 6) In the case of lymph node metastasis, each lymphatic drainage area is counted as one organ.\n4. All oligoprogressive lesions are deemed suitable for radiotherapy, with a maximum diameter of any single oligoprogressive lesion not exceeding 5 cm, and at least one measurable lesion (according to RECIST v1.1 criteria); bone metastases without soft tissue formation are eligible but considered non-measurable lesions; if bone metastases have soft tissue formation and meet measurable criteria, they are considered measurable lesions;\n5. Child-Pugh score for liver function ≤ 7;\n6. Estimated life expectancy greater than 3 months;\n7. Function of essential organs meets the following criteria: white blood cells ≥ 3.0 × 10\\^9\u002FL, neutrophils ≥ 1.5 × 10\\^9\u002FL, platelets ≥ 50.0 × 10\\^9\u002FL, hemoglobin ≥ 90 g\u002FL; serum albumin ≥ 2.8 g\u002FdL; total bilirubin ≤ 1.5 × ULN, ALT\u002FAST\u002FALP ≤ 2.5 × ULN; serum creatinine ≤ 1.5 × ULN or creatinine clearance \\> 60 mL\u002Fmin; no severe organic disease;\n8. Participants must have the ability to understand and voluntarily sign a written informed consent form. Consent must be obtained before any specific study procedures begin, and the participant must agree to follow the medication and post-operative follow-up requirements outlined in the study design.\n\nExclusion Criteria:\n\n1. Received first-line treatment other than bevacizumab combined with atezolizumab\u002Fsintilimab or lenvatinib with or without PD-1 antibody;\n2. Tumor progression within 3 months after first-line standard systemic therapy;\n3. Experienced ≥ Grade 3 severe adverse reactions after first-line standard therapy;\n4. Brain metastasis with hemorrhage at baseline or after first-line systemic therapy;\n5. Previous radiotherapy to the site of the oligoprogressive lesion;\n6. Active bleeding (e.g., hematemesis, hemoptysis) within 2 months before enrollment;\n7. Received any other antitumor drug therapy or local treatment within 3 months before enrollment;\n8. Severe impairment of the heart, lungs, kidneys, or other vital organs, active infections (other than viral hepatitis), or other severe comorbidities that make the patient unable to tolerate treatment;\n9. History of other malignancies, except for non-melanoma skin cancer, carcinoma in situ of the cervix, or early-stage prostate cancer that has been cured;\n10. Presence of autoimmune diseases or other conditions requiring long-term use of steroids;\n11. Known or suspected allergy to the study drugs or any drugs related to this trial;\n12. History of organ transplantation;\n13. Pregnant or breastfeeding women;\n14. Other factors that may affect the patient\\'s enrollment and assessment results;\n15. Refusal to follow the follow-up requirements set by this study protocol or refusal to sign the informed consent form.","75 Years",{"count":136,"type":20},70,[138],"PHASE2","Approximately 70% of hepatocellular carcinoma (HCC) patients are diagnosed at an advanced stage, with no opportunity for curative treatments. For these patients, systemic therapies are the main treatment modalities. However, the objective response rates of first-line systemic treatments are currently only 20-35%, and most patients inevitably develop drug resistance and disease progression during treatment, thus taking second-line therapies. Second-line treatment options include regorafenib, pembrolizumab, and others, but clinical studies have shown a median progression-free survival of only 2.6-3.1 months, indicating an urgent need to improve efficacy.\n\nStereotactic body radiotherapy (SBRT) has been widely used in recent years for curative treatment of early-stage liver cancer or as neoadjuvant and adjuvant therapy for patients with portal vein tumor thrombus. It is one of the important approaches in the multidisciplinary management of HCC. Researches have shown that SBRT has a synergistic effect with systemic drug therapy, potentially enhancing the efficacy of targeted and immunotherapies. Therefore, this study aims to conduct a prospective, randomized, controlled phase II clinical trial in patients with oligoprogressive HCC after standard first-line systemic treatment to evaluate whether adding SBRT to second-line systemic therapy can improve the efficacy of second-line treatment. The primary endpoint of the study is progression-free survival (PFS), while secondary endpoints include overall survival (OS), objective response rate (ORR), and treatment-related adverse events. We aim to comprehensively assess the effectiveness and safety of combining SBRT with second-line systemic therapy in treating oligoprogressive HCC patients.",[141,27],"Hepatocellular Carcinoma","NOT_YET_RECRUITING","2024-09-09",{"date":145,"type":34},"2024-09-19",{"date":147,"type":20},"2024-10-01",{"date":149,"type":20},"2026-10-31",{"name":151,"class":41},"Sun Yat-sen University",{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":158,"eligibilityCriteria":159,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":160,"targetDuration":4,"studyType":21,"phases":162,"briefSummary":163,"conditions":164,"keywords":4,"overallStatus":142,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":4},"100553725","stereotactic-body-radiotherapy-sbrt-for-oligoprogressive-breast-cancer-100553725","NCT06489821","STereotactic Body Radiotherapy (SBRT) for Oligoprogressive Breast Cancer","STereotactic Body Radiotherapy (SBRT) After oligoprogRession Metastatic Breast Cancer (STAR-B)","STAR-B","Inclusion Criteria:\n\n1. Diagnosis of progressive metastatic breast cancer on first line systemic therapy, including either hormone receptor positive, Her-2 negative (HR+\u002FHer2-) on endocrine therapy + CDK4\u002F6 inhibitor or Her-2 positive (hormone receptor positive or negative \u002FHer2+) on Her2-targeted therapy regimens.\n2. Progressive disease limited to \"oligoprogression\", defined as progression of 5 or fewer extra-cranial lesions with otherwise controlled systemic disease on current line of systemic therapy.\n3. Patients must have previously controlled disease for at least six months on current systemic therapy\n4. Deemed a candidate for stereotactic body radiotherapy (SBRT) to all OP lesions\n\nExclusion Criteria:\n\n1. Requires change in systemic therapy line at the time of OP as determined by medical oncologist;\n2. Progression on 2nd line or subsequent lines of therapy\n3. Lacks CT or bone scan Imaging within previous 45 days;\n4. Progression in \\>3 sites in the liver or lung;\n5. Hormone positive disease on endocrine therapy only at time of enrollment;\n6. Previous radiotherapy to same site or vicinity preventing definitive SBRT (e.g. within 5 cm);\n7. Lesions deemed not amenable to SBRT due to large size or location;\n8. Unacceptable fracture risk according to clinician judgement for bone lesions;\n9. Brain metastasis or Spinal cord compression;\n10. History of major radiosensitivity syndrome or contraindications to radiotherapy.",{"count":161,"type":20},36,[23],"Recent advances in systemic therapy have facilitated improved progression-free survival (PFS) and treatment tolerability in metastatic breast cancer patients (MBC). Oligoprogression (OP) refers to progression limited to five or fewer sites in otherwise controlled systemic disease on a drug therapy. Stereotactic body radiotherapy (SBRT) has the potential to locally ablate resistant OP lesions that develop on a systemic treatment, and may consequently delay the need for change in drug therapy, delay time to chemotherapy and prolong PFS. This is a phase II trial of SBRT plus continuation of current systemic therapy line for OP MBC patients, to determine rate of delay of change in systemic therapy of at six months. PFS, time to chemotherapy and quality of life will also be assessed.",[165,27],"Metastatic Breast Cancer","2024-07-04",{"date":168,"type":34},"2024-07-08",{"date":170,"type":20},"2024-09-01",{"date":172,"type":20},"2027-12-31",{"name":174,"class":41},"Juravinski Cancer Center"]