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Chemotherapy and Pelvic Hypofractionated Radiation Followed by Surgery Cervical Cancer

NCT03750539 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-11-14

No results posted yet for this study

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.

Conditions

  • Cervix Cancer

Interventions

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

Sponsors & Collaborators

  • National Institute of Cancerología

    lead OTHER_GOV

Principal Investigators

  • David F Cantu-de Leon, MD, Msc, PhD · Instituto Nacional de Cancerologia, Columbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-10
Primary Completion
2024-11-10
Completion
2025-11-10

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03750539 on ClinicalTrials.gov