Chemotherapy and Pelvic Hypofractionated Radiation Followed by Surgery Cervical CancerLast updated on July 2021
- Recruitment Status
- Estimated Enrollment
- Same as current
- Cervix Cancer
- Not Applicable
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Phase II Comparative Randomized Open-labelMasking: None (Open Label)Primary Purpose: Treatment
- Between 18 years and 80 years
- Only males
Toxicity will be assessed six times during this study. In addition to the primary endpoint of patient-reported gastrointestinal toxicity, a broad range of other toxicities will be comprehensively evaluated, including urinary, hematologic and dermatologic, this data will allow to determining the effe...
Toxicity will be assessed six times during this study. In addition to the primary endpoint of patient-reported gastrointestinal toxicity, a broad range of other toxicities will be comprehensively evaluated, including urinary, hematologic and dermatologic, this data will allow to determining the effect of hypofractionated radiation therapy on each of these aspects of toxicity from pelvic radiation. Additionally, will be recognized that it is possible to advance in the understanding of the clinical risk and benefits of hypofractionation. The primary endpoint will be acute gastrointestinal toxicity using the Radiation Therapy Oncology Group (RTOG) common toxicity criteria. In total, evaluating toxicity in different time points will allow determining if hypofractionation is secure concerning acute and late toxicity, that would enable to offer an optional treatment to this kind of patient. Chronic gastrointestinal toxicity from radiation continues to increase rapidly over two years, and then the rate of developing new toxicities slows. As a result, the majority of chronic radiation-induced gastrointestinal toxicity by evaluating toxicity two years after completion of radiotherapy is going to be identified. Quality of life (QOL) will be evaluated using EORTC QLQ-CX24 and EORTC QLQ-C30, both of which have been validated and available in Mexican Spanish.
- NCT #
- Not Provided
- Principal Investigator: David F Cantu-de Leon, MD, Msc, PhD Instituto Nacional de Cancerologia, Columbia