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Clinical Response and Toxicity of Hypo-fractionated Chemoradiotherapy in Cervix Cancer

NCT04831437 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-10-12

No results posted yet for this study

Summary

Uterine cervix cancer can be treated definitively with concurrent chemoradiation (external beam radiotherapy and chemotherapy) followed by high dose rate brachytherapy. Treatment duration can be shortened by increasing the dose per fraction of treatment which can reduce costs and patient exposure. The aim of our study is to determine the non-inferiority of hypofractionated radiotherapy compared with conventional treatment.

Conditions

  • Cervix Uteri Cancer

Interventions

RADIATION

Hypofractionated EBRT

EBRT dose of 40Gy in 15 fractions over 3 weeks plus 3 weekly infusions of cisplatin 40mg/m2

RADIATION

Standard EBRT

EBRT dose of 45Gy in 25 fractions over 5 weeks plus 5 weekly infusions of cisplatin 40mg/m2

Sponsors & Collaborators

  • Tehran University of Medical Sciences

    lead OTHER

Principal Investigators

  • Afsaneh Maddah-Safaei, M.D. · Tehran University of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2023-03-31
Completion
2028-03-31

Countries

  • Iran

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 NCT04831437 on ClinicalTrials.gov