CT Image Based Closest-to-tumor Radiation in Cervical Cancer

Active, not recruiting

• Conditions: Malignant neoplasm of overlappingsites of cervix uteri,

• Registration Number: CTRI/2022/11/047633
• Lead Sponsor: Chittaranjan National Cancer Institute

Brief Summary

Aim of this observational study is to evaluate feasibility of target delineation on CT image for image guided brachytherapy in cervical cancer along with dosimetric analysis & comparison between volume-based dose prescription & point A based dose prescription.The proposed prospective study will be carried out at the Department of Radiation Oncology, Chittaranjan National Cancer Institute,Kolkata. Patients accrued in the study as per inclusion and exclusion criteria, will receive brachytherapy after completion of external-beam radiotherapy. Periodic follow-up of patients will be done to assess the treatment response & toxicities with special attention to GI and GU toxicity.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-12
• Last Update Posted: 2024-07-27

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• 1.Patients of cervical cancer sent from multidisciplinary tumor board after being proved on histopathology (squamous cell or adenocarcinoma) with FIGO stage IB2 to III 2.Eastern Cooperative Oncology Group performance status upto 2 3.Hemoglobin >10 gm%, Total leukocyte count> 4000 cells/cmm, Platelet count> 1,00,000 cells/cmm (initially or after correction by blood transfusion).
• 4.Liver function test- AST< 2×Upper normal limit, bilirubin <2×upper normal limit Kidney function test- Serum creatinine<1.5 mg/dL and calculated creatinine clearance using the Cockroft-Gault formula >50 ml/min 5.Patient with no history or current clinical evidence of any hematological or bleeding disorders 6.No history of drug use which results in hematological toxicity 7.HBsAg, Anti-HCV, HIV-I & -II Antibody non-reactive patients.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the feasibility of delineating HR-CTV on CT image following IBS-GEC ESTRO-ABS recommendations & Pre- & Post-EBRT MRI images.	At baseline
Computation of target coverage along with the doses received at Point A.	At baseline
To compare the doses received by bladder, rectum & bowel as per volume-based dose prescription and Point A-based dose prescription.	At baseline

Secondary Outcome Measures

Name	Time	Method
To assess the treatment response & toxicity with special attention to Gastrointestinal (GI) & Genitourinary(GU) toxicity.

Trial Locations

Locations (1)

Chittaranjan National Cancer Institute; 🇮🇳 Kolkata, WEST BENGAL, India

Chittaranjan National Cancer Institute

🇮🇳Kolkata, WEST BENGAL, India

Adhiraj Dandapat

Principal investigator

9932711670

dandapatadhiraj@gmail.com