NCT04070976

Chemotherapy and Pelvic Hypofractionated Radiation Followed by Brachytherapy for Cervical Cancer

Phase II Randomized Controlled Trial of Concomitant Chemoradiotherapy With Standard Fractionation Compared to Hypofractionated Concomitant Chemoradiotherapy Followed by Brachytherapy, for Clinical Stage III Cervical Cancer Patients

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 82 (estimated)
• Sponsor: National Institute of Cancerología · Other Government
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main goal of this trial is to assess the safety and response rate to concomitant chemotherapy and external hypofractionated radiotherapy followed by brachytherapy in patients with clinical stage III cervical cancer. The trial will take place in the National Cancer Institute (INCan). Patients will be randomized into two groups: chemotherapy with external standard fractionated radiotherapy (45 Gy in 25 fractions) followed by brachytherapy or chemotherapy with external hypofractionated radiotherapy (37.5 Gy in 15 fractions) followed by brachytherapy.

Detailed description

The primary endpoint will be to assess the safety and efficacy to concomitant chemoradiotherapy followed by brachytherapy in cervical cancer clinical stage III. Secondary endpoints comprises security profile, survival rates, quality of life and related costs. The data obtained by this protocol will allow to determine the effect of hypofractionated radiation therapy and its possible adverse effects. Side effects will be classified according to version 4.03 of CTCAE guidelines. The highest CTCAE grade will be obtained for each type of event, for each patient and the Radiation Therapy Oncology Group (RTOG) scale will be applied to evaluate the events related to conventional and hypofractionated radiotherapy, as well as brachytherapy. Quality of life (QOL) will be evaluated using EORTC QLQ-CX24 and EORTC QLQ-C30, both have been validated and available in Mexican Spanish. Direct and indirect expenses related to the treatment will be evaluated based on the treatment costs stipulate by the institution and the information obtained by the social workers.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
RADIATION	Hypofractionated therapy	All patients will be treated with an external beam of 37.5 Gray in 15 fractions (2.5 Gray / fraction). They will be treated once a day, 5 days a week. If photon energy 6 MV or 10 MV is used, the patient should be treated with a 4-field technique using the anterior/posterior field and 2 lateral fields. The specification of the dose is in terms of a dose to a point at or near the center of the target volume. For all field dispositions, the dose specification point is the common isocenter of all beams.
RADIATION	Standard therapy	All patients will be treated with external beam radiotherapy with 50 Gray in 25 fractions (1.8-2 Gray / fraction). They will be treated once a day, 5 days a week. If photon energy 6 MV or 10 MV is used, the patient should be treated with a 4-field technique using anterior/posterior fields and 2 lateral fields. The specification of the dose is in terms of a dose to a point at or near the center of the target volume. For all field dispositions, the dose specification point is the common isocenter of all beams.

Timeline

• Start date: 2019-07-01
• Primary completion: 2024-07-30
• Completion: 2024-12-30
• First posted: 2019-08-28
• Last updated: 2023-11-14

Locations

1 site across 1 country: Mexico