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NCT Number: NCT07435623

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

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

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Key information

Conditions

Endometrial Cancer Cervix Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

Tata Memorial Center

Mumbai, Maharashtra, 400012, India

Location status: Recruiting

Location contact

Supriya Sastri (Chopra), MD

PRINCIPAL_INVESTIGATOR

Supriya sastri (Chopra), MD

CONTACT

[email protected]

022-68735000 ext. 5113

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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. Assess local regional control

    Time frame: 3 Years

    To assess 3 years local regional control from the time of treatment completion till 3 years

  4. 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

  5. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Supriya Chopra

CONTACT

[email protected]

02227405000 ext. 5113

Sponsors and collaborators

Lead sponsor

Tata Memorial Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Feb 27, 2026
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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