Late Radiation Toxicities in Cervical and Endometrial Cancer: A Postoperative IMRT/Brachytherapy Study

February 26, 2026 updated by: Supriya Sastri (chopra), Tata Memorial Hospital

Assessment of Late Gastrointestinal and Genitourinary Toxicities in Cervical and Endometrial Cancer Requiring Postoperative IMRT and/or Brachytherapy

Cervical cancer is the 4th most common cancer in women globally and the 2nd most common in India. In India, between 2018 and 2020, cervical cancer saw a surge of 26,985 from 2018 to 2020. The treatment for cervical cancer depends on the clinical stage. Treatment of early stage cervical cancer (Stage IB1-IIA) includes chemo-radiation or surgery +/- adjuvant (CT)RT and VBT if indicated. The choice of adjuvant treatment relies on identifying specific risk factors. Patients fulfilling Sedli's intermediate-risk criteria, requires pelvic radiotherapy alone and patients with high-risk Peter's criteria, require adjuvant chemoradiation. This risk-based approach helps tailor adjuvant therapies to individual patient.

India reported 16,413 new cases and 6,385 deaths of endometrial cancer, with a mortality rate of 0.73%. The primary treatment for endometrial carcinoma is total abdominal hysterectomy with bilateral salpingo-oophorectomy (TAH-BSO). The Adjuvant treatment depends on risk stratification group according to ESGO/ESTRO/ESP guidelines determined through molecular-based risk stratification. Adjuvant treatment includes radiotherapy, chemotherapy, and brachytherapy.

To reduce the burden of acute and late toxicity, advanced external radiation techniques like image guided intensity modulated radiotherapy (IG IMRT) are used. IG IMRT have shown their potential to reduce late toxicity in long term survivors compared to 3DCRT technique. Since January 2020, our institution (TATA memorial centre, Mumbai) has incorporated routine IG-IMRT (Image-Guided Intensity-Modulated Radiation Therapy) for treatment of cervical and endometrial cancer. However, no post-implementation assessment of treatment outcomes and potential toxicity has occurred. This is retrospective observational study aims to evaluate the clinical application of IG-IMRT.

Primary aim of this study is to audit the 3 years incidence of ≥ grade II Gastrointestinal & Genitourinary toxicities in women receiving Adjuvant IMRT (with or without chemotherapy) between January 2020 to June 2023

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • India
    • Maharashtra
      • Mumbai, Maharashtra, India, 400012
        • Recruiting
        • Tata Memorial Center
        • Contact:
        • Principal Investigator:
          • Supriya Sastri (Chopra), MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Annually 40-50 patients of post-operative cervix and post-operative endometrial cancer which are treated with adjuvant radiotherapy (with or without chemotherapy) and/or Brachytherapy are seen by gynaecological services. So, assuming 40-50 patients per year we expect this 3-year study to have up to 300 patients

Description

Inclusion Criteria:

  • Patients more than 18 years of age at the time of diagnosis.
  • All patients with confirmed histological diagnosis of cervical or endometrial cancer.
  • Only those patients who have received adjuvant (chemo)radiotherapy with IMRT and/or brachytherapy at TMH/ACTREC will be included.
  • Patients whose follow up information available

Exclusion Criteria:

  • Patients with incomplete treatment details.
  • Patient having residual disease post-surgery.
  • Patient treated for post-operative recurrences.
  • Patient who lost to follow up.
  • Patients with Immunosuppressive disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3 years incidence of ≥ grade II Gastrointestinal & Genitourinary toxicities
Time Frame: 3 years
To audit the 3 years incidence of ≥ grade II Gastrointestinal & Genitourinary toxicities in women receiving Adjuvant IMRT (with or without chemotherapy) for cervical and endometrial cancer between January 2020 to December 2023
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Report acute toxicity in patients receiving adjuvant RT
Time Frame: 3 years
To report acute toxicity in patients receiving adjuvant RT from the time of treatment completion till 3 years
3 years
Assess disease free and overall survival (for cervix and endometrial cancer separately).
Time Frame: 3 Years
To assess 3-year disease free and overall survival (for cervix and endometrial cancer separately) from the time of treatment completion to 3 years
3 Years
Assess local regional control
Time Frame: 3 Years
To assess 3 years local regional control from the time of treatment completion till 3 years
3 Years
Report dose-volume parameters for prediction of late grades II-IV gastrointestinal and genitourinary toxicity
Time Frame: 3 Years
Report dose-volume parameters for prediction of late grades II-IV gastrointestinal and genitourinary toxicity from treatment completion till 3 years
3 Years
compare outcomes with ongoing and completed institutional postoperative IMRT trials
Time Frame: 3 Years
To compare outcomes with ongoing and completed institutional postoperative IMRT trials from the time of treatment completion to 3 years
3 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tata Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2025

Primary Completion (Actual)

July 10, 2025

Study Completion (Estimated)

August 25, 2026

Study Registration Dates

First Submitted

February 20, 2026

First Submitted That Met QC Criteria

February 20, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

March 2, 2026

Last Update Submitted That Met QC Criteria

February 26, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4454

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cervix Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guatemala

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe