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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07435623
Enrollment
300
Registered
2026-02-27
Start date
2025-05-10
Completion date
2026-08-25
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervix Cancer, Endometrial Cancer

Keywords

Cervical Cancer, Endometrical Cancer ,Gastrointestinal & Genitourinary toxicities

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

Interventions

None listed

Sponsors

Tata Memorial Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
3 years incidence of ≥ grade II Gastrointestinal & Genitourinary toxicities3 yearsTo 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

MeasureTime frameDescription
Report acute toxicity in patients receiving adjuvant RT3 yearsTo report acute toxicity in patients receiving adjuvant RT from the time of treatment completion till 3 years
Assess disease free and overall survival (for cervix and endometrial cancer separately).3 YearsTo assess 3-year disease free and overall survival (for cervix and endometrial cancer separately) from the time of treatment completion to 3 years
Assess local regional control3 YearsTo assess 3 years local regional control from the time of treatment completion till 3 years
Report dose-volume parameters for prediction of late grades II-IV gastrointestinal and genitourinary toxicity3 YearsReport dose-volume parameters for prediction of late grades II-IV gastrointestinal and genitourinary toxicity from treatment completion till 3 years
compare outcomes with ongoing and completed institutional postoperative IMRT trials3 YearsTo compare outcomes with ongoing and completed institutional postoperative IMRT trials from the time of treatment completion to 3 years

Countries

India

Contacts

CONTACTSupriya Chopra
supriyasastri@gmail.com02227405000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026