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

NCT07435623RecruitingOBSERVATIONAL

Summary

Key Facts

Lead Sponsor

Tata Memorial Hospital

Enrollment

300

Start Date

2025-05-10

Completion Date

2025-07-10

Study Type

OBSERVATIONAL

Official Title

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

Conditions

Endometrial CancerCervix Cancer

Eligibility

Age Range

18 Years – 75 Years

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

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

Time frame: 3 years

Secondary Outcomes

Report acute toxicity in patients receiving adjuvant RT

To report acute toxicity in patients receiving adjuvant RT from the time of treatment completion till 3 years

Time frame: 3 years

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

To assess 3-year disease free and overall survival (for cervix and endometrial cancer separately) from the time of treatment completion to 3 years

Time frame: 3 Years

Assess local regional control

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

Time frame: 3 Years

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

Report dose-volume parameters for prediction of late grades II-IV gastrointestinal and genitourinary toxicity from treatment completion till 3 years

Time frame: 3 Years

compare outcomes with ongoing and completed institutional postoperative IMRT trials

To compare outcomes with ongoing and completed institutional postoperative IMRT trials from the time of treatment completion to 3 years

Time frame: 3 Years

Locations

Tata Memorial Center, Mumbai, India