NCT03750539

Chemotherapy and Pelvic Hypofractionated Radiation Followed by Surgery Cervical Cancer

Phase II Randomized Study of Concurrent Chemotherapy and Pelvic Radiation Therapy With Standard Fractionated Compared to Hypofractionated Followed by Surgery for Patients With Locally Advanced Cervical Cancer.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: National Institute of Cancerología · Other Government
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the role of hypofractionated in the treatment of locally advanced cervical cancer. The study will be conducted in Honduras and Mexico, and patients will be randomized to a standard fraction (45 Gy in 25 fractions) or hypofractionated (37.5Gy in 15 fractions) followed by surgery. Patients will receive weekly cisplatin with their treatments at 40 mg/m2. Response rate, survival, and toxicity will be evaluated.

Detailed description

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.

Conditions

• Cervix Cancer

Interventions

Type	Name	Description
RADIATION	Standard radiotherapy	External Bean Pelvic Radiation: 50 Gy in 15 fractions, with weekly cisplatin.
RADIATION	hypofractionated radiotherapy	External Bean Pelvic Radiation: 37.5 Gy in 15 fractions, with weekly cisplatin.
PROCEDURE	Radical hysterectomy	Radical hysterectomy and pelvic and paraaortic lymph node resection

Timeline

• Start date: 2017-11-10
• Primary completion: 2024-11-10
• Completion: 2025-11-10
• First posted: 2018-11-23
• Last updated: 2023-11-14

Locations

2 sites across 1 country: Mexico