Hypofractionated External-beam RadiOtherapy for Intact Cervical Cancer (HEROICC-Trial): A Feasibility Study
NCT04583254
Summary
External radiation given in 25 fractions or so together with weekly chemotherapy and followed by 3 or 4 fractions of brachytherapy is the standard of care for patients with locally advanced cervical cancer. This study investigates the role of shortened external radiotherapy regimen (hypofractionated radiotherapy) by randomizing patients to this experimental regimen versus the standard of care.The purpose of this study is to access the feasibility of patient accrual to this trial in the Canadian setting and to provide an initial evaluation of cancer response and treatment tolerability.
Eligibility
Inclusion Criteria: * Age 18 years or older * International Federation of Gynecology and Obstetrics (FIGO) IA or IB1 cervical cancers if not surgical candidates, but amenable to definitive chemoradiotherapy as proposed in this trial. * FIGO Stage IB2, IB3, IIA or IIB cervical cancers * FIGO stage IIIC1 cervical cancers are candidates but must meet all the following criteria: 1. largest node is less than 3 cm 2. less than 3 pathological nodes 3. No nodes located in the common iliac chain. 4. Cervical confined or with parametrial invasion * Histologically-confirmed invasive uterine cervical carcinoma of subtypes squamous cell, adenocarcinoma or adenosquamous cell * Candidate for definitive chemoradiotherapy to be delivered with weekly cisplatin * Brachytherapy candidate Exclusion Criteria: * FIGO stage IIIA, IIIB, IIIC2, IVA or IVB * FIGO stage IIIC1 with node greater than 3 cm, common iliac node or greater than 2 pathological nodes * Previous pelvic or abdominal radiotherapy * Patients requiring paraaortic nodal irradiation * Inflammatory bowel disease * Connective tissue disorder (eg. scleroderma, systemic lupus erythematous) * Neuroendocrine, glassy cell, small cell, adenoid cystic carcinoma, adenoid basal carcinoma, clear cell, serous, endometrioid, verrucous carcinoma, melanoma, and sarcoma histologies * Patient unable to undergo MR scan * Eastern Cooperative Oncology Group (ECOG) performance status greater than 3 * Not a cisplatin candidate
Conditions2
Interventions1
Related trials
- A Clinical Study on the Treatment of LACC With Cadonilimab Combined With Chemotherapy Followed by CCRT — Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Adaptive Hypofractionated Radiotherapy for Locally Advanced NSCLC Based on Dynamic Enhanced MRI — Sun Yat-sen University
- Combination of Concurrent Chemoradiotherapy With Surufatinib and Tislelizumab in Patients With Locally Advanced Non-Small Cell Lung Cancer — Sun Yat-sen University
- Definitive Hypofractionated Intensity-modulated Radiation Theraphy With Concurrent Chemotherapy in Cervical Cancer — Samsung Medical Center
- Glucocorticoids Combined With Concurrent Chemoradiotherapy for Unresectable Thymoma — Sun Yat-sen University
- Hypofractionated Versus Conventional Chemoradiotherapy Followed by Consolidative Immunotherapy in Locally Advanced NSCLC — Sun Yat-sen University
- Hypofractionated vs. Conventional Chemoradiotherapy After Induction Chemo-immunotherapy for Unresectable Esophageal Squamous Cell Carcinoma — Sun Yat-sen University
- Reduced-dose RT With/Without CCT Versus Standard CCRT for High-risk LANPC Who Achieved CR Post Induction Chemotherapy — Sun Yat-sen University
Browse More Trials
Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.
NCT04583254