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

NCT07435623 | Recruiting

• 1 other identifier: 4454
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Endometrial Cancer; Cervix Cancer

Keywords

Cervical Cancer, Endometrical Cancer ,Gastrointestinal & Genitourinary toxicities

Outcome Measures

Primary Outcomes (1)

• 3 years incidence of ≥ grade II Gastrointestinal & Genitourinary toxicities

  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 Outcomes (5)

• Report acute toxicity in patients receiving adjuvant RT

  3 years

• Assess disease free and overall survival (for cervix and endometrial cancer separately).

  3 Years

• Assess local regional control

  3 Years

• Report dose-volume parameters for prediction of late grades II-IV gastrointestinal and genitourinary toxicity

  3 Years

• compare outcomes with ongoing and completed institutional postoperative IMRT trials

  3 Years

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tata Memorial Hospital: lead

Study Sites (1)

Tata Memorial Center

Mumbai, Maharashtra, 400012, India

RECRUITING

Related Publications (31)

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• ANNEXURE: Common Terminology Criteria for Adverse Events (CTCAE) v5.0

  BACKGROUND

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  BACKGROUND

MeSH Terms

Conditions

Endometrial Neoplasms; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Cervical Diseases

Central Study Contacts

Supriya Chopra

CONTACT

02227405000; supriyasastri@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 20, 2026
• First Posted: February 27, 2026
• Study Start: May 10, 2025
• Primary Completion: July 10, 2025
• Study Completion (Estimated): August 25, 2026
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)