NCT07435623

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Tata Memorial Hospital · Other Government
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2025-05-10
• Primary completion: 2025-07-10
• Completion: 2026-08-25
• First posted: 2026-02-27
• Last updated: 2026-03-02

Locations

1 site across 1 country: India