[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Ontario Clinical Oncology Group (OCOG)\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":159},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,43,76,101,126],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100471333","phase-3-a-randomized-trial-of-five-fraction-partial-breast-irradiation-rapid2-100471333",false,"NCT05417516","A Randomized Trial of Five Fraction Partial Breast Irradiation (RAPID2)","A Randomized Trial of Five-Fraction Partial Breast Irradiation (RAPID2)","Inclusion Criteria:\n\nFor inclusion in this study, patients must fulfill all of the following criteria:\n\n1. Female with a new histological diagnosis of invasive carcinoma of the breast with no evidence of metastatic disease (see AJCC TNM Cancer Staging, Appendix II).\n2. Treated by BCS with microscopically clear resection margins \\>= 1mm for invasive and non-invasive disease or no residual disease on re-excision.\n3. Negative axillary node involvement as determined by either sentinel lymph node biopsy or axillary node dissection or clinical assessment with a negative axillary ultrasound and\u002For biopsy, for women with unifocal tumours \\\u003C= 2cm, histologic grade 1 or 2, ER or PR+ and HER2-ve that are being planned for endocrine therapy\n\nExclusion Criteria:\n\nPatients who satisfy any of the following exclusion criteria are NOT eligible for this study:\n\n1. Age less than 50 years.\n2. Known to be BRCA 1 and\u002For BRCA 2 positive.\n3. Tumour size \\>3cm in greatest diameter on pathological examination.\n4. Evidence of extensive intraductal component (EIC) (defined as an invasive tumour with a ductal carcinoma in situ (DCIS) component comprising at least 25% and extending beyond the invasive component to surrounding normal breast tissue) with the following exception: smaller tumours with EIC where the combined size (of the invasive and DCIS components) are \\\u003C= 3cm remain eligible\n5. Evidence of a DCIS component \\> 3cm\n6. Lobular carcinoma only.\n7. More than one primary tumour in different quadrants of the same breast (patients with multifocal breast cancer are eligible).\n8. Synchronous or previous contralateral breast cancer (patients with contralateral DCIS or LCIS are eligible).\n9. History of non-breast malignancy within the last 5 years other than treated non-melanoma skin cancer or treated in-situ carcinoma.\n10. Known pregnancy or currently lactating.\n11. Inability to localize tumour bed on CT planning (no evidence of surgical clips or seroma).\n12. Inability to plan the patient for the experimental technique.","FEMALE","50 Years","120 Years",{"count":20,"type":21},910,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The primary objective of this study is to determine in women with node negative BC ≤3cm in size, if PBI compared to WBI, both given once-a-day over 1 week following BCS, is non-inferior for LR and reduces adverse cosmesis. The primary outcomes are LR and patient-assessed cosmesis at 3 years post randomization.",[27,28,29],"Breast Neoplasm Female","Radiotherapy","Cosmetic Outcome","RECRUITING","2026-06-16",{"date":33,"type":34},"2026-06-18","ACTUAL",{"date":36,"type":34},"2023-11-20",{"date":38,"type":21},"2031-11",{"name":40,"class":41},"Ontario Clinical Oncology Group (OCOG)","OTHER",29,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":51,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},"100548490","phase-2-outpatient-and-intermittent-dosing-of-elranatamab-in-relapsedrefractory-multiple-myeloma-100548490","NCT06421675","Outpatient and Intermittent Dosing of Elranatamab in Relapsed\u002FRefractory Multiple Myeloma","A Study of Elranatamab Management With Outpatient and Intermittent Dosing in Relapsed\u002FRefractory Multiple Myeloma","EMBRACE","Inclusion Criteria:\n\n1. Relapsed and\u002For refractory MM defined as:\n\n   1. Documented evidence of progressive disease (PD) after achieving at least minimal response (MR) for ≥ 1 cycle during a previous MM treatment (i.e., relapsed MM).\n   2. Disease progression during or within 60 days from the end of the most recent MM treatment (i.e., refractory MM).\n2. Measurable disease based on IMWG criteria, defined as at least one of the following, documented within 28 days before enrollment:\n\n   1. Serum M-protein ≥ 0.5 g\u002Fdl.\n   2. Urine M-protein excretion ≥ 200 mg\u002F24 h.\n   3. Serum-free light chains (FLC) assay: Involved FLC level ≥ 10 mg\u002Fdl (≥ 100 mg\u002Fl) AND an abnormal serum-free light chain ratio (\\\u003C 0.26 or \\> 1.65) only for patients without measurable serum or urine M protein.\n3. Receipt of at least three prior classes of drugs either in separate regimens or as combinations.\n\n   The three classes are defined as:\n\n   An immunomodulatory drug (lenalidomide or pomalidomide), a proteasome inhibitor (bortezomib, ixazomib, carfilzomib), and an anti-CD38 drug (daratumumab or isatuximab).\n4. At least 18 years of age.\n5. Eastern Cooperative Oncology Group (ECOG) performance status score of ≤2.\n\nExclusion Criteria:\n\nMedical conditions\n\n1. Active plasma cell leukemia (either 20% of peripheral white blood cells or \\> 2.0 × 109\u002FL circulating plasma cells by standard differential).\n2. Amyloidosis.\n3. POEMS syndrome (Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal plasma cell disorder, Skin Changes).\n4. Monoclonal gammopathy of unknown significance or smoldering multiple myeloma.\n5. Solitary plasmacytoma.\n6. Stem cell transplant within 12 weeks prior to enrollment or active graft versus host disease.\n7. History of prior treatment with a BCMA targeting agent.\n\n   Laboratory Parameters\n8. Laboratory results within 28 days as per below prior to enrollment:\n\n   * Absolute neutrophil count (ANC) ≤ 1.0 x 109 \u002FL) (use of growth factor is permitted if completed at least 7 days prior to enrollment).\n   * Platelet count ≤ 25 x 109 \u002FL (transfusion support permitted if completed at least 7 days prior to enrollment).\n   * Hemoglobin ≤ 8.0 g\u002FdL (transfusion support permitted if completed at least 7 days prior to enrollment, concurrent erythropoietin stimulating agents allowed).\n   * Serum AST and ALT \\> 2.5 x upper limit of normal (ULN).\n   * Creatinine clearance \\\u003C 30 mL\u002Fmin (according to the Cockcroft Gault formula, by 24-hour urine collection for creatinine clearance, or according to local institutional standard method).\n   * Total bilirubin \\> 2.0 x ULN (≥ 3.0 unless known to have Gilbert's disease).\n\n   Support Requirement\n9. As this protocol requires outpatient administration, the patient will be excluded if they cannot agree to the following for the first 9 days post-first dose of drug administration:\n\n   1. Staying within 60 minutes of travel distance to their trial-based hospital.\n   2. Must have a caregiver\u002Fsupport person who will stay with the patient.\n   3. Patient and\u002For their caregiver\u002Fsupport person agree to monitor and record oral temperature q8 hours.\n   4. Patients must agree that if they have an oral temperature of (≥38°C), they must report to the study team within 1 hour and can come to the hospital for admission within 2 hours.\n\n   Other co-morbidities\n10. Impaired cardiovascular function or clinically significant cardiovascular diseases, defined as any of the following within 6 months before enrollment:\n\n    * Acute myocardial infarction or acute coronary syndromes (eg, unstable angina, coronary artery bypass graft, coronary angioplasty or stenting, symptomatic pericardial effusion).\n    * Clinically significant cardiac arrhythmias (eg, uncontrolled atrial fibrillation or uncontrolled paroxysmal supraventricular tachycardia).\n    * Thromboembolic or cerebrovascular events (eg, transient ischemic attack, cerebrovascular accident, deep vein thrombosis \\[unless associated with a central venous access complication\\], or pulmonary embolism).\n    * Prolonged QT syndrome (or triplicate average QTcF \\>470 msec at screening).\n11. Ongoing Grade ≥2 peripheral sensory or motor neuropathy.\n12. History of Guillain-Barre Syndrome (GBS) or GBS variants, or history of any Grade ≥3 peripheral motor polyneuropathy.\n13. Unresolved acute effects of any prior therapy for MM in the last three months to either baseline severity or NCI CTCAE ≤Grade 1.\n14. Active HBV, HCV, SARS-CoV2, HIV, or any active, uncontrolled bacterial, fungal, or viral infection.\n15. Any other active malignancy within 2 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.\n16. Any serious and\u002For unstable pre-existing medical, psychiatric disorder, or other conditions (including lab abnormalities), or surgical (major surgery within 14 days prior to enrollment) that could interfere with the patient's safety, obtaining informed consent or compliance to the study procedures.\n17. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to elranatamab or any of the components of the study treatment.\n\n    Concomitant Medications\n18. Treatment with a chemotherapeutic or anti-MM drug within the last 28 days or 5 half-lives (whichever is shorter) prior to enrollment or are currently enrolled in another interventional clinical study.\n19. Receipt of any other therapy to treat cancer (including radiation, biologics, cellular therapies, and\u002For steroids at doses \\> 20 mg dexamethasone or equivalent) within 14 days prior to the enrollment.\n20. Receipt of any live vaccine within 30 days prior to enrollment or expected need of live vaccination during study participation. (Administration of locally approved non-live vaccine can be done as per local guidelines during the screening and\u002For treatment period including the COVID-19 mRNA vaccine. Elranatamab should be administered ± 7 days from the SARS-CoV-2 vaccine administration).\n\n    Pregnancy and Contraception\n21. Pregnancy or lactating female or inability of female patients of childbearing potential (FCBP) to meet contraception requirements (see Section 5.1.3.).\n\n    Informed Consent\n22. Inability to provide signed, informed consent.","ALL","18 Years",{"count":54,"type":21},40,[56],"PHASE2","A phase II study of single agent elranatamab in patients with relapsed and\u002For refractory multiple myeloma (MM) who have previously received at least three classes of therapeutic agents and are refractory to the last line of treatment. The primary objective of this study is to improve the tolerability and safety of elranatamab in patients with relapsed and\u002For refractory multiple myeloma by evaluating an outpatient and intermittent dosing strategy.",[59],"Refractory Multiple Myeloma",[61,62,63,64,65,66],"relapsed","refractory","multiple myeloma","elranatamab","cytokine release syndrome","immune effector-cell associated neurotoxicity","2026-06-15",{"date":69,"type":34},"2026-06-17",{"date":71,"type":34},"2025-03-28",{"date":73,"type":21},"2028-12",{"name":40,"class":41},6,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":94,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},"100505828","radiation-omission-in-patients-with-clinically-node-negative-breast-cancer-undergoing-lumpectomy-100505828","NCT05866458","Radiation OmisSion in PAtients With CLinically Node Negative Breast Cancer Undergoing Lumpectomy","Radiation OmisSion in PAtients With CLinically Node Negative Breast Cancer Undergoing Lumpectomy and With a PathologIc Complete REsponse After Neoadjuvant Chemotherapy","ROSALIE","Inclusion Criteria:\n\n1. Female patient with a new histological diagnosis of clinical T1-3 N0 breast cancer (any tumour sub-type).\n2. Negative lymph node involvement at initial presentation, documented by imaging (US or MRI), fine needle aspiration (FNA) or core needle biopsy.\n3. Treated with a minimum of 8 weeks NAC, with patients with Her2+ disease receiving targeted anti-Her2+ therapy.\n4. Marker clip placed in the tumour bed prior to or during neoadjuvant chemotherapy when the tumour can still be identified.\n5. Treated by BCS with complete excision of the tumour bed and axillary staging surgery (either sentinel lymph node biopsy or axillary lymph node dissection).\n6. Final pathology demonstrating a pCR \\[defined as absence of residual invasive and in-situ breast cancer within the breast or lymph nodes (ypT0N0)\\].\n\nExclusion Criteria:\n\n1. Age less than 50 years.\n2. Inflammatory breast cancer or breast cancer invading the skin or chest wall (T4 disease).\n3. Multicentric disease (i.e., breast cancer involving more than one quadrant in the same breast).\n4. Prior history of ipsilateral or contralateral in-situ or invasive breast cancer. Patients with a history of lobular carcinoma in-situ (LCIS) are ineligible.\n5. Synchronous contralateral in-situ or invasive breast cancer.\n6. BRCA (breast cancer gene) 1 or 2 genetic mutation carrier, or other genetic mutation present associated with increased risk of breast cancer.\n7. Other previous non-breast malignancies except adequately treated non-melanoma skin cancers, in situ cancers or other cancers curatively treated with no evidence of disease for ≥ 5 years.\n8. Inability to complete entire course of neoadjuvant therapy (minimum of 8 weeks of treatment).\n9. Patients with HR+ (hormone receptor) disease who are not planned to have endocrine therapy initiated.\n10. Patients with Her2+ disease who have not received or are not planned to receive Her2 targeted therapy.\n11. ECOG (Eastern Cooperative Oncology Group) performance status \\> 3.\n12. Inability to provide informed consent.",{"count":85,"type":21},352,"OBSERVATIONAL","To de-escalate radiation therapy in women with breast cancer.",[89],"Breast Cancer",[91,92,93],"Clinically node negative breast cancer","Ipsilateral breast tumour recurrence","Neoadjuvant chemotherapy",{"date":69,"type":34},{"date":96,"type":34},"2024-03-12",{"date":98,"type":21},"2031-10",{"name":40,"class":41},23,{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":16,"minAge":109,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":112,"conditions":113,"keywords":115,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":119,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},"100423701","prospective-evaluation-of-breast-conserving-surgery-alone-in-low-risk-ductal-carcinoma-in-situ-dcis-100423701","NCT04797299","Prospective Evaluation of Breast-Conserving Surgery Alone in Low-Risk Ductal Carcinoma in Situ (DCIS)","Prospective Evaluation of Breast-Conserving Surgery Alone in Low-Risk Ductal Carcinoma in Situ Defined by a Molecular Expression Assay Combined With Clinico-Pathological Features","ELISA","Inclusion Criteria:\n\n1. Female patient \\> 45 years of age with DCIS without microinvasion.\n2. Tumour size ≤ 2.5cm.\n3. Treated by BCS with clear resection margins ≥ 2 mm or no residual disease on re-excision.\\*\n\n   \\* Patients with anterior margins and posterior margins ≥1 mm are eligible. Or if the dissection was confirmed to be taken to skin and down to fascia with no DCIS present at inked margins.\n4. Oncotype DX DCIS score with a predicted 10-year risk of LR ≤10%.\n\nExclusion Criteria:\n\n1. Multifocal DCIS.\n2. History of any invasive breast cancer or non-invasive breast cancer in the ipsilateral breast.\n3. Synchronous or previous invasive or non-invasive breast cancer.\n4. Prior history of invasive cancer within the last 5 years, excluding non-melanoma skin cancers.\n5. ECOG performance status ≥3.\n6. Life expectancy \\\u003C10 years.\n7. Geographic inaccessibility for follow-up.","46 Years",{"count":111,"type":21},526,"To evaluate whether the combination of clinicopathological factors and the use of the Oncotype DX DCIS score can avoid radiation in women with low risk DCIS who have had breast conserving surgery (BCS)",[114],"DCIS",[116,117,118],"Ductal Carcinoma in Situ","Breast Conserving Surgery","Oncotype DX DS",{"date":69,"type":34},{"date":121,"type":34},"2022-11-23",{"date":123,"type":21},"2035-11-30",{"name":40,"class":41},24,{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":134,"minAge":52,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":22,"phases":137,"briefSummary":138,"conditions":139,"keywords":142,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":158},"100566373","phase-2-study-of-recurrence-directed-therapy-rdt-with-or-without-androgen-deprivation-therapy-adt-in-patients-with-radio-recurrent-oligo-metastatic-hormonecastrate-sensitive-prostate-cancer-romcspc-100566373","NCT06654336","Study of Recurrence-directed Therapy (RDT) With or Without Androgen-Deprivation Therapy (ADT) In Patients With Radio-recurrent Oligo-metastatic Hormone\u002FCastrate Sensitive Prostate Cancer (romCSPC)","Phase II Randomized Trial of Recurrence-directed Therapy (RDT) With or Without Androgen-Deprivation Therapy (ADT) In Radio-recurrent Oligo-metastatic Hormone\u002FCastrate Sensitive Prostate Cancer (romCSPC).","RATIONAL","Inclusion Criteria:\n\n1. Previous biopsy-proven localized prostate adenocarcinoma (without predominant features of sarcomatoid, small cell or neuroendocrine carcinoma) treated with definitive or salvage radiotherapy ≥ 2 years or more before enrollment.\n2. Recurrent Oligo-metastatic CSPC, M0 on conventional imaging (bone scan and CT scan of chest\u002Fabdomen\u002Fpelvis) with ≤ 5 metastases cumulative on all imaging, including MRI and PSMA-PET.\n\n   Note: Patients with conventional imaging M1 oligometastatic CSPC, who have no more than 5 metastatic sites in all imaging modalities including MRI and PSMA-PET, will be accepted for study enrollment.\n3. All sites of recurrent disease must be amenable to treatment with radiotherapy or surgery in the judgment of the investigator.\n4. Biochemical recurrent prostate cancer with ONE of the following PSA recurrence definitions:\n\n   1. After definitive radiotherapy (prostate in situ), with PSA ≥ nadir + 2ng\u002Fml;\n   2. After prostatectomy and adjuvant\u002Fsalvage radiotherapy, with PSA ≥ nadir + 0.2ng\u002Fml.\n\nExclusion Criteria:\n\n1. Age \\\u003C 18.\n2. ECOG Performance Status ≥3.\n3. PSA ≥ 20 ng\u002Fml.\n4. Treatment with ADT within 2 years from study enrollment or treatment with any androgen receptor axis within 6 months from study enrollment.\n5. Prior treatment with chemotherapy for prostate cancer or bilateral orchiectomy. Note: prior chemotherapy for a different type of cancer is allowed if the patient has been continuously disease-free for \\> 3 years.\n6. Intracranial or intrathecal metastasis.\n7. Spinal cord compression, or spinal intramedullary metastasis.\n8. Prior malignancy (except non metastatic, non- melanomatous skin cancer) unless disease free for \\> 3 years.\n9. Bilateral hip prosthesis, treated earlier with definitive prostate radiotherapy, who have evidence of local disease recurrence within the prostate and no option for salvage treatment with brachytherapy or surgery.\n10. Previous documented hypersensitivity to ELIGARD® or other GnRH agonist analogs of components of such preparations.","MALE",{"count":136,"type":21},162,[56],"The goal of this study is to determine whether the addition of Androgen Deprivation Therapy (ADT) utilizing the study drug ELIGARD® to Recurrence- Directed Therapy (RDT) improves progression-free survival (PFS) compared to RDT alone in patients with early radio-recurrent oligo-metastatic castrate \u002F hormone sensitive prostate cancer (romCSPC). Participants will be assessed at standard of care clinic visits every 3 months. The follow-up period is 36 months.",[140,141],"Prostate Adenocarcinoma","Castration Sensitive Prostate Cancer",[143,141,144,145,146,147,28,148,149],"Prostate adenocarcinoma","Recurrent Oligo-metastatic Castration Sensitive Prostate CancerSPC","Andrigen Deprivation Therapy","Eligard","Recurrence Directed Therapy","Bio-chemical recurrence","Androgen Deprivation Therapy","2026-03-11",{"date":152,"type":34},"2026-03-13",{"date":154,"type":21},"2026-03-30",{"date":156,"type":21},"2031-06",{"name":40,"class":41},3,""]