[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Cancer Research Antwerp\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":174},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,46,91,123,150],{"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":26,"conditions":27,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100537804","phase-2-treatment-of-high-risk-prostate-cancer-guided-by-novel-diagnostic-radio--and-molecular-tracers-100537804",false,"NCT06282588","Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers","Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers (THUNDER): A Two-part Phase 2\u002F 3 Trial","THUNDER","Inclusion Criteria:\n\n1. Histopathology-proven PCa\n2. High-risk locally advanced disease is defined as any of the following factors: PSA \\> 20 ng\u002FmL OR T-stage 3 or 4 OR Gleason score 8-10 OR cN1.\n\n   Note: documentation of the clinical T-stage may be obtained from any clinical assessment acceptable for clinical T staging including physical exam (DRE), transrectal ultrasound, CT or MRI. Documentation for the N1 stage can be defined on CT or MRI.\n3. An Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0 or 1.\n4. Willingness to undergo a PSMA PET\u002F CT with or without contrast.\n\n   1. Subjects who are PSMA PET\u002F CT positive for at least one regional or distant (extra-pelvic) lesion at screening (PSMA PET scans will be assessed as described in the study imaging manual), will be eligible to be randomized to either arm of the Phase 3 study. A lesion is considered positive if it has a E-PMSA score of 4 or 5.\n   2. Pending confirmation of their Decipher score, subjects who are PSMA PET\u002F CTnegative for regional or distant lesions at screening (PSMA PET scans will be assessed as described in the study imaging manual), will be eligible for inclusion in either the Phase 3 study (if a high \\[\\> 0.85\\] Decipher score is confirmed) or the non-randomized Phase 2 study (if a low\u002F intermediate \\[≤ 0.85\\] Decipher score is confirmed).\n5. Willingness to have their primary tumor sequenced for determination of Decipher score\n\n   1. Subjects who have a negative PSMA PET\u002F CT and a tumor with a low\u002F intermediate Decipher score (≤ 0.85) will be eligible to enter the non-randomized Phase 2 study.\n   2. Subjects who have a negative PSMA PET\u002F CT and a tumor with a high Decipher score (\\> 0.85) will be eligible to be randomized to either arm of the Phase 3 study.\n   3. In subjects with positive PSMA PET\u002F CT, the Decipher score will not determine the treatment allocation.\n6. Willingness to undergo SOC RT and long-term ADT (treatment with darolutamide and\u002F or LHRHA)\n7. Subject is able and willing to provide written informed consent, which includes compliance with and ability to undergo all study procedures and attend the scheduled follow-up visit\u002Fs per protocol.\n8. Subject must be over 18 years of age.\n9. Subject able to swallow whole study drug tablets.\n10. To avoid risk of drug exposure through the ejaculate (even men with vasectomies), subjects must use a condom during sexual activity while on study drug and for 3 months after the last administration of study treatment. Donation of sperm is not allowed during the treatment phase and for 3 months after the last administration of study treatment.\n11. Adequate organ function determined by the following local laboratory values:\n\n    1. Adequate bone marrow function: Hemoglobin ≥ 100 g\u002FL, white cell count (WCC) ≥ 4.0 x 109\u002FL, absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL and platelets \\> 100 x 109\u002FL\n    2. Adequate renal function: calculated creatinine clearance \\> 30 mL\u002Fmin (Cockroft-Gault)\n    3. Adequate liver function: ALT \\\u003C 2 x upper limit of normal (ULN) and total bilirubin \\\u003C 1.5 x ULN, (or if total bilirubin is between 1.5 to 2 x ULN, they must have a normal conjugated bilirubin)\n    4. Testosterone levels \\> 50 ng\u002FdL\n\nExclusion Criteria:\n\n1. Definitive radiologic evidence of metastatic disease outside of the pelvic nodes (M1a, M1b or M1c) on conventional imaging (i.e., bone scan, CT scan, MRI)\n2. PCa with predominant non-adenocarcinoma features (sarcomatoid or spindle or neuroendocrine small cell or squamous cell components or other non-adenocarcinoma)\n3. Prior pelvic radiotherapy\n4. Contraindications for pelvic radiotherapy\n5. Contraindications for ADT (treatment with darolutamide and\u002F or LHRHA)\n6. Contraindications or known allergy to PSMA PET\u002F CT tracers.\n7. Prior local therapy for PCa (e.g., radical prostatectomy, high-intensity focused ultrasound \\[HIFU\\], cryotherapy). Subjects with previous transurethral resection of the prostate (TURP) or Millin prostatectomy are eligible for participation\n8. Prior systemic therapy for PCa, except for patients with a positive PSMA PET\u002F CT staging with ADT started no more than 4 weeks prior to randomization.\n9. Current use of 5-alpha reductase inhibitor Note: if the alpha reductase inhibitor is stopped ≥ 2 weeks prior to enrollment, the subject is eligible.\n10. Current chronic use of opioid analgesics, for ≥3 weeks for oral or ≥7 days for non-oral formulations\n11. History of seizure or any condition that may predispose to seizure (including, but not limited to prior stroke, transient ischemic attack or loss of consciousness within ≤1 year prior to enrollment; brain arteriovenous malformation; or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect)\n12. Any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the subject\n13. Major surgery within 21 days prior to enrollment.\n14. History of:\n\n    1. Loss of consciousness or transient ischemic attack or stroke within 6 months prior to enrollment, or\n    2. Significant cardiovascular disease within 6 months prior to enrollment: including myocardial infarction, unstable angina, congestive heart failure (New York Heart Association \\[NYHA\\] classification Grade 2 or greater), ongoing arrhythmias of Grade \\> 2 (National Cancer Institute Common Terminology Criteria for Adverse Events \\[NCI-CTCAE\\] v5.0), thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism), coronary artery bypass graft. Chronic stable atrial fibrillation on stable anticoagulant therapy is allowed.\n15. Known GI disease or GI procedure that could interfere with the oral absorption or tolerance of darolutamide, including difficulty swallowing tablets\n16. History of another malignancy within 5 years prior to enrollment except for those malignancies treated with curative intent with a predicted risk of relapse of less than 10% including but not limited to non-melanoma carcinoma of the skin; or adequately treated, non-muscle-invasive urothelial carcinoma of the bladder (i.e., Tis, Ta and low grade T1 tumors). All such cases with a history of malignancy within the last 5 years are to be discussed with study team before enrollment. Melanoma in-situ and other adequately treated in-situ neoplasms are not considered malignancies for the purposes of eligibility assessment\n17. Concurrent illness, including severe infection that might jeopardize the ability of the subject to undergo the procedures outlined in this protocol with reasonable safety (human immunodeficiency virus \\[HIV\\] infection is not an exclusion criterion if it is controlled with anti-retroviral drugs that are unaffected by concomitant darolutamide)\n18. Subjects who are sexually active with women of childbearing potential and not willing\u002Fable to use medically acceptable and highly effective forms of contraception during study treatment and for at least 3 months after the last administration of study treatment. Contraception must include: Additional birth control with low failure rate (less than 1% per year) when used consistently and correctly, e.g., combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device (IUD), intrauterine hormone releasing system (IUS), bilateral tubal occlusion, vasectomized partner, true sexual abstinence.","MALE","18 Years",{"count":20,"type":21},493,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE2","PHASE3","This Investigator-initiated, Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers (THUNDER) study will be conducted in subjects with high-risk localized or locally advanced prostate cancer (PCa). The study contains both a randomized Phase 3 treatment intensification study, as well as a treatment de-intensification non-randomized Phase 2 study. The aim of the THUNDER study is to improve the outcome of high-risk PCa by improved risk stratification. Novel radiotracers and a genomic classifier (Decipher) will be used to guide treatment decisions, instead of standard imaging which is limited by lower sensitivity and specificity.\n\nThe hypothesis for the study is that treatment intensification based on a positive PSMA PET\u002F CT scan or Decipher high score (\\> 0.85) improves time to new metastases detected on PSMA PET\u002F CT in high-risk PCa. In patients who are PSMA PET\u002F CT negative with a low\u002F intermediate Decipher score (≤ 0.85), it is hypothesized that treatment de-intensification will improve patient quality of life while maintaining a good oncological outcome.\n\nThe study will be conducted at multiple centers across Europe. Participation in the study will comprise a screening period, where the screening assessments must be completed before subjects are enrolled and randomized (only for Phase 3 subjects). Eligible, consenting subjects will then undergo treatment according to their assigned study phase and treatment group, to occur over up to 96 weeks (24 months) with a post-treatment follow-up period to monitor safety and efficacy. The study will be closed when 96 events have been registered for the primary endpoint, which is expected to be at 7-8 years from the time of randomization of the first subject.",[28],"Prostate Cancer",[30,31,32],"High-risk","PSMA PET\u002FCT scan","Decipher","RECRUITING","2026-03-17",{"date":36,"type":37},"2026-03-19","ACTUAL",{"date":39,"type":37},"2023-12-13",{"date":41,"type":21},"2030-12-31",{"name":43,"class":44},"Cancer Research Antwerp","OTHER",9,{"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":66,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},"100572929","preoperative-radiation-therapy-and-immediate-breast-reconstruction-100572929","NCT06739655","Preoperative Radiation Therapy and Immediate Breast Reconstruction","Preoperative Radiation Therapy and Immediate Breast Reconstruction, a Phase 3 Randomized Controlled Trial in the Belgian Population","PRADAIIBE","Screening assessments, including review of all study eligibility criteria must be completed before enrolment and randomisation.\n\nInclusion criteria:\n\nIn order to be eligible to participate in this study, a participant must meet all of the following criteria:\n\n1\\. Women ≥18 years with histopathologically confirmed breast cancer who:\n\n1.a. require SSM\u002FNSM for any reason (e.g. extensive disease)\n\n1.b. require postoperative radiation therapy of at least the chest wall\n\n1. c. have a wish for a breast reconstruction\n2. An Eastern Cooperative Oncology Group (ECOG) performance status grade ≤ 2\n3. Participant is able and willing to provide written informed consent, which includes compliance with and ability to undergo all study procedures, and attend the scheduled follow-up visit(s) per protocol.\n\nExclusion criteria:\n\nA potential participant who meets any of the following criteria will be excluded from participation in this study:\n\n1. A previous history of breast cancer or irradiation of the chest wall for any other indication, on the other side (ipsilateral). A bilateral SSM\u002FNSM + reconstruction (e.g. in case of a contralateral prophylactic SSM\u002FNSM), or previous contralateral breast cancer disease\u002Ftreatment, do not fall under this criterium and are thus allowed.\n2. Collagen synthesis disease\n3. Ongoing pregnancy\n4. Actively breastfeeding\n5. Smoking at time of inclusion (a history of smoking is allowed but needs to be registered in the eCRF). No interval between smoking cessation and study inclusion is defined, but the reconstructive surgeon needs to be willing to operate the patient using autologous tissue transfer. This generally translates to a smoking cessation of \\>3months preoperatively.\n6. BMI \\> 35 kg\u002Fm2\n7. cT4d tumour, metastatic disease or any reason making SSM\u002FNSM not indicated","FEMALE",{"count":56,"type":21},180,[58],"NA","The goal of this phase III randomized controlled trial (PRADAIIBE) is to assess if preoperative radiation therapy (Preop-RT) combined with immediate breast reconstruction (IBR) can safely improve both aesthetic and quality of life outcomes in breast cancer patients, compared to the standard of care (SoC) therapy consisting of post-mastectomy radiation therapy (PMRT) and delayed\u002Fimmediate breast reconstruction, in a population of breast cancer patients with an indication of mastectomy and PMRT.\n\nThe following hypotheses and outcomes will be assessed at the primary endpoint of 1 year of follow-up:\n\n* Efficacy: Does Preop-RT+IBR lead to a higher BREAST-Q satisfaction with breasts score (primary endpoint), EQ-5D-5L VAS score , EQ-5D-5L Index score, AIS-Total Aesthetic Score, or a shorter treatment duration compared to SoC?\n* Safety: Does Preop-RT+IBR lead to an increase in adverse events (general or surgical), a lower rate of pathologic Complete Response (pCR), or worse survival outcomes compared to SoC? \\[Note: this study was not powered as a non-inferiority trial, all outcomes will be pooled internationally with parallel studies\\]\n\nEligible and consenting participants will undergo screening and baseline assessments. They will then be randomised between experimental (Preop-RT+IBR) and control (SoC) groups, in a 1:1 stratified variable block size design. Follow-up will take place at 3 months, 1, 2, 5, and 10 years after the last study treatment. At baseline and during each follow-up visit each participant will complete the Breast Q 'satisfaction with breasts' and EQ-5D-5L scales, photographs will be taken. During follow-up pCR will be assessed if applicable, adverse events will be registered, and oncological follow-up will be recorded.",[61,62,63,64,65],"Breast Neoplasms","Breast Carcinoma","Breast Adenocarcinoma","Cancer","Neoplasm",[67,68,69,70,71,72,73,74,75,76,77,78,79,80,81],"Breast cancer","Radiotherapy","PRADA","Breast reconstruction","BreastQ","QoL","Skin Sparing Mastectomy","Mastectomy","Breast surgery","radiation therapy","Preoperative radiation therapy","Preoperative RT","Cosmesis","Breast satisfaction","Immediate Breast Reconstruction","2026-02-02",{"date":84,"type":37},"2026-02-04",{"date":86,"type":37},"2025-02-20",{"date":88,"type":21},"2038-02-20",{"name":43,"class":44},6,{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":99,"minAge":18,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":22,"phases":102,"briefSummary":103,"conditions":104,"keywords":109,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},"100604173","early-radiotherapy-versus-observation-for-high-risk-asymptomatic-or-minimally-symptomatic-bone-metastases-100604173","NCT07146074","Early Radiotherapy Versus Observation for High-risk Asymptomatic or Minimally Symptomatic Bone Metastases","Phase III Randomized Trial for High-risk Asymptomatic or Minimally Symptomatic Bone Metastases: Early Radiotherapy Versus Observation","HERMES","Inclusion Criteria:\n\n* I1: Histologically confirmed solid tumor malignancy (with polymetastastic spread (≥ 3 metastases))\n* I2: High-risk bone metastasis(es) that is (are) asymptomatic or minimally symptomatic:\n\n  \\*Asymptomatic or minimally symptomatic is defined as follows: O Numeric Pain Rating Scale (NRS) score ≤2 for the specific lesion(s)\n\n  \\*High-risk is defined as follows (i.e. at least one of the following points must be applicable): O Bulky site of disease in bone (diameter ≥ 2 cm) O Disease involving the hip (acetabulum, femoral head, femoral neck), shoulder (acromion, glenoid, humeral head), or sacroiliac joints O Disease in long bones with cortical involvement of \\>1\u002F3 in proportion to the diameter of the bone (humerus, radius, ulna, clavicle, femur, tibia, fibula, metacarpals, phalanges) O Disease in vertebrae of the junctional spine (C1-2, C7- T1, T12-L1, L5-S1) and\u002For disease with posterior element involvement or epidural extension (Bilsky epidural compression score 1a-3) \\[Bilsky et al\\]. The posterior elements of the spine consist of the pedicles, laminae, facets (articular processes), transverse processes, and the spinous process.\n* I3: Number of Risk Factors (NRF) prognostic score 0-2\n* I4: Age ≥ 18 years\n* I5: Ability to provide informed consent (either by the patient or by a legally authorized representative)\n* I6: A female participant is eligible to participate if she confirms not to be pregnant at screening, and one of the following conditions applies:\n\nIs not a woman of child bearing potential or A woman of child bearing potential must confirm that she is not pregnant at screening and must agree to use a very effective method of birth control\n\nExclusion Criteria:\n\n* E1: Previous RT to the target treatment site(s)\n* E2: NRF prognostic score 3\n* E3: Serious medical co-morbidities that preclude radiotherapy\n* E4: Bone lesion complicated with a pathological fracture or impending pathologic fracture for which prophylactic stabilization is recommended, characterized by Mirels score of ≥9 \\[Mirels et al\\].\n* E5: Spinal metastasis with SINS score \\>13 requiring upfront neurosurgical stabilization \\[Fourney et al\\].\n* E6: More than 5 high-risk asymptomatic or minimally symptomatic metastatic bone locations\n* E7: Patient already included in another clinical trial that would interfere with the HERMES clinical trial, as assessed by the Investigator.","ALL",{"count":101,"type":21},120,[58],"The goal of this clinical trial is to learn whether radiotherapy (i.e. treatment with ionizing radiation to destroy cancer cells) can prevent symptoms in patients with metastatic cancer, having high-risk bone metastases that currently result in no or only mild symptoms. High-risk bone metastases are bone metastases at high-risk of developing bone complications, such as fractures or myelum compression.\n\nThe main questions this study aims to answer are:\n\n* Can preventive radiation of high-risk asymptomatic or minimally symptomatic bone metastases (and observation or medication) decrease the number of skeletal related events (i.e. bone complications due to bone metastases) in patients with metastatic cancer?\n* Can preventive radiation of high-risk asymptomatic or minimally symptomatic bone metastases (and observation or medication) decrease the need for hospitalization related to such bone metastases, improve overall survival and (health-related) quality of life?\n* What are the side effects of preventive radiation of high-risk asymptomatic or minimally symptomatic bone metastases?\n\nResearchers will compare 2 treatment groups in order to answer the questions listed above: 1 group treated with medication or observation alone (group A) and 1 group treated with medication or observation and preventive radiotherapy (group B).\n\nParticipants will\n\n* be screened to assess whether they are eligible to participate in the study.\n* be randomized (i.e. drawn) into the 2 treatment groups mentioned above.\n* be treated with preventive radiotherapy if they were drawn in treatment group B.\n* need to attend follow-up visits (may be via teleconsultation) at 1, 3, 6, 12, 18 and 24 months after date of randomization during which safety and efficacy is monitored. During these follow-up visits, the general health condition of the participant is evaluated, the occurrence of any bone complication, the medications taken by the participant are registered, the degree of pain and location of the high-risk bone metastases are determined and possible side effects are registered. Furthermore, the participant needs to complete 2 questionnaires at each visit regarding his\u002Fher quality of life.",[105,106,107,108],"Solid Neoplasms","Bone Metastases","Asymptomatic or Minimally Symptomatic","High Risk for Skeletal Events",[110,111,68,112,113],"Bone metastases","Randomized","Symptomatic skeletal events","Preventive","2026-01-16",{"date":116,"type":37},"2026-01-20",{"date":118,"type":37},"2025-02-05",{"date":120,"type":21},"2029-02",{"name":43,"class":44},8,{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":99,"minAge":18,"maxAge":4,"enrollmentInfo":131,"targetDuration":4,"studyType":22,"phases":133,"briefSummary":134,"conditions":135,"keywords":137,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":45},"100569221","stereotactic-body-radiation-therapy-for-inoperable-non-metastasized-pancreatic-adenocarcinoma-100569221","NCT06691425","Stereotactic Body Radiation Therapy for Inoperable Non-metastasized Pancreatic Adenocarcinoma","Stereotactic Body Radiation Therapy for Inoperable Non-metastasized Pancreatic Adenocarcinoma: a Randomized Phase II Study","TORPEDO","Inclusion Criteria:\n\n* Participant must be over 18 years of age.\n* Participant is able and willing to provide written informed consent which includes compliance with and ability to undergo all study procedures and attend the scheduled follow-up visits per protocol.\n* Either locally advanced or borderline resectable pancreatic adenocarcinoma, as confirmed by diagnostic images (CT, MRI or PET-CT scan) and based on vessel involvement according to the NCCN guidelines. Only borderline resectable pancreatic cancer (BRPC) patients who are medically unfit for surgery or refusing surgery can be included.\n* Adequate organ function determined by the following laboratory values:\n\n  * Adequate bone marrow function: absolute neutrophil count ≥1500\u002Fmm\\^3, platelet count ≥100000\u002Fmm\\^3 and hemoglobin ≥9 g\u002Fdl\n  * Adequate renal function: Creatinine ≤1.5 x upper normal limit of normal (ULN) or estimated eGFR more than 45 ml\u002Fmin\n  * Adequate liver function: total bilirubin ≤1.5 ULN (after adequate biliairy stenting with metal stent) and alanine aminotransferase (ALT) ≤5x ULN\n* An Eastern Cooperative Oncology Group (ECOG) performance status grade of 0-2.\n* A life expectancy ≥3 months\n* A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:\n\n  * Is not a woman of child bearing potential or\n  * A woman of child bearing potential must have a negative serum pregnancy test at screening and must use a very effective method of birth control.\n\nExclusion Criteria:\n\n* Extrapancreatic metastatic disease as defined on diagnostic imaging (CT, MRI or PET-CT scan) or laparoscopy, including distal nodal involvement beyond the peripancreatic tissues and\u002For distant metastases.\n* Massive gastric or intestinal invasion as assessed on imaging and\u002For endoscopy. Direct invasion of the duodenal mucosa as visible on endoscopic ultrasound (EUS).\n* Prior radiation therapy that could hamper adequate dose delivery\n* Contraindication to magnetic resonance imaging (MRI)\n* Diagnosis of another malignancy within 2 years prior to randomization, except non-melanoma skin cancer, non-invasive bladder cancer, carcinoma in situ of the cervix or non-metastatic prostate cancer. Patients with a history of other malignancies are eligible if they have been continuously disease-free for at least 2 years after definitive primary treatment.\n* Any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the subject.\n* Patient already included in another clinical trial that would interfere with the TORPEDO clinical trial, as assessed by the Investigator.\n* Known presence of an active ulcer (i.e. detected during standard of care diagnostic assessments)\n\nAdditional exclusion criteria after restaging (i.e. within 1 week after 3 months of induction chemotherapy) and prior to randomization:\n\n* Extrapancreatic metastatic disease as defined on diagnostic imaging, including distal nodal involvement beyond the peripancreatic tissues and\u002For distant metastases\n* Massive gastric or intestinal invasion as assessed on imaging and\u002For endoscopy. Direct invasion of the duodenal mucosa as visible on EUS.\n* Known presence of an active ulcer (i.e. detected during standard of care diagnostic assessments)",{"count":132,"type":21},160,[58],"This is a multicenter randomized phase II trial that aims to include 160 patients with a non-metastatic (localized), inoperable pancreatic tumor. The study will take place at multiple centers across Europe. The primary objective of the study is to demonstrate superiority in progression free survival (PFS) by adding stereotactic body radiation therapy (SBRT) to chemotherapy for patients with an inoperable non-metastasized pancreatic tumor. SBRT is a radiotherapy technique (i.e. destroying cancer cells by means of ionizing irradiation) in which tumors can be irradiated with a high radiation dose. Surrounding healthy tissue is thus spared to the maximum extent. The primary endpoint of the TORPEDO study is 2-year PFS defined as the percentage of patients who are free of disease progression at 110 weeks after the date when the patients were drawn into 2 treatment groups (i.e. randomization). Secondary outcomes are, among others, quality of life, acute and late toxicity (i.e. adverse events), metastasis-free survival, local progression-free survival, overall survival, subsequent resectability, R0 resection and surgical morbidity.\n\nDuring the study, patients without disease progression after 3 months of induction chemotherapy will be randomized 1:1 to either treatment with chemotherapy or treatment with a combination of chemotherapy and SBRT (5 x 8 Gy). After randomization, ten-weekly follow-up visits will occur during two years to evaluate the quality of life, general blood parameters and general health condition of the patient. Moreover, toxicity will be evaluated as well as efficiency and safety of the treatment (e.g. by means of imaging). At any time during this follow-up period, imaging (CT scan, MRI scan) will be used to determine whether surgery can still be performed to improve patient survival.",[136],"Non-metastasized Unresectable Pancreatic Carcinoma",[138,111,139,140,141],"Pancreatic cancer","stereotactic body radiation therapy","inoperable","non-metastasized","2025-08-05",{"date":144,"type":37},"2025-08-08",{"date":146,"type":37},"2024-07-19",{"date":148,"type":21},"2030-07",{"name":43,"class":44},{"id":151,"slug":152,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":156,"eligibilityCriteria":157,"healthyVolunteers":11,"sex":99,"minAge":18,"maxAge":4,"enrollmentInfo":158,"targetDuration":4,"studyType":22,"phases":160,"briefSummary":161,"conditions":162,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":45},"100563217","separation-surgery-followed-by-stereotactic-ablative-body-radiotherapy-sabr-versus-sabr-alone-for-spinal-metastases-100563217","NCT06613295","Separation Surgery Followed by Stereotactic Ablative Body Radiotherapy (SABR) Versus SABR Alone for Spinal Metastases","Separation Surgery Followed by Stereotactic Ablative Body Radiotherapy Versus Stereotactic Ablative Body Radiotherapy Alone for Spinal Metastases Invading the Spinal Canal: a Randomised, Non-inferiority Trial","SABR-MESCC","Inclusion Criteria:\n\n* Diagnosis of a solid malignant tumour (preferentially histologically proven;alternatively obtained by spinal surgical procedure)\n* Age 18 years or older\n* Histological, radiological or scintigraphical evidence of spinal metastasis (no limitation in the number of sites of metastases)\n* Spinal instability neoplastic score (SINS) \\\u003C13 (i.e. no need for stabilisation of the spine) (see Appendix 6)\n* Spinal metastasis with MESCC: ESCC grade 1c, 2 and 3 (see Appendix 7)\n* Ambulatory: being able to walk 10m without aid or with aid (cane, rollator, one persons help).\n* Life expectancy estimated to be at least 3 months.\n* World Health Organization (WHO) Performance Status of 0-2 (some help) (see Appendix 3)\n* Patient has given written informed consent.\n\nExclusion Criteria:\n\n* Contra indication for MRI scan (e.g. pacemaker)\n* Previous RT or surgery at the level of the affected vertebrae\n* Non-solid primary tumours (e.g. lymphoma, multiple myeloma, germ cell tumours)\n* Non ambulatory at presentation\n* More than 3 affected vertebrae in one target site\n* More than 2 treatment sites\n* SINS ≥ 13 (unstable spine)",{"count":159,"type":21},128,[58],"This is a non-inferiority, randomised controlled trial to investigate the effect of stereotactic ablative body radiotherapy (SABR) compared to separation surgery followed by SABR in ambulatory patients with malignant epidural spinal cord compression (MESCC).\n\nThe primary objective of the project is investigating the effect of SABR compared to separation surgery followed by SABR in ambulatory patients with MESCC on retaining ambulatory function. The primary endpoint of the study is ambulatory function 3 months post treatment defined as: being able to walk 10m without aid; being able to walk 10m with aid (cane, rollator, one persons help, …); not being able to walk. Secondary outcomes are local control, progression free survival, early and late adverse effects, quality of life, effect on pain and need for reintervention.\n\nThe aim is to randomise 128 patients 1:1 to either \"separation surgery\" followed by SABR (5x 8.0 Gy postoperative) (control arm) vs. SABR alone (5x 8.0 Gy) (study arm).\n\nPatients will be evaluated at 3 and 6 months after treatment with MRI scan, quality of life questionnaires, anamnestic and clinical evaluation at clinical follow ups for assessment of ambulatory function, acute and late toxicity and need for reintervention. Moreover, at 6 weeks, 12 months and 24 months after treatment a teleconsult for assessment of ambulatory function, and need for reintervention will be performed.",[163,164,165],"Solid Tumor","Spinal Neoplasms","Spinal Tumor","2024-09-23",{"date":168,"type":37},"2024-09-25",{"date":170,"type":37},"2022-03-07",{"date":172,"type":21},"2027-03-01",{"name":43,"class":44},""]