Bladder Cancer Adjuvant Radiotherapy Trial

NCT02951325 · tracked via the Priya Life Science India tracker

Sponsor

Tata Memorial Centre

Phase

Phase 3

Started

2016-06-02

Last updated

2025-02-13

Condition(s) studied

Bladder CancerUrothelial Carcinoma Bladder

Investigational drug(s) / intervention(s)

Adjuvant RT

Adjuvant RT: Radiation therapy: All patients will be offered conformal technique with IMRT +/- image guidance. The adjuvant RT will start within 8 weeks from the date of surgery if chemotherapy not planned or 4 weeks from the date of last adjuvant chemo cycle. Dose: •50.4 Gray (Gy) in 28 fractions (1.8Gy/#) for the nodal PTV. For R1 and/or R2 resection increased to 54-56 Gy in 28 fractions based on the constraints achieved during planning. Patient assessments: Clinical: * Toxicity: 1. Weekly RT with toxicity scoring. 2. RTOG toxicity criteria at baseline, 6-8 weeks post RT and f/b 3 monthly x 2 years and 6 monthly x 5 years. 3. QOL will be assessed at baseline f/b 3-6 monthly. * Disease evaluation: i. first f/u all patients will be at 6-8 week to assess toxicity. ii. Clinical evaluation of the disease will be done at each f/u visit. iii. CT scan (abdomen and pelvis) 6 monthly from visit 2 onwards up to 2 years f/b 12 monthly or as clinically indicated.

Study summary

Aim and objectives:

This trial aims to evaluate the role of adjuvant radiotherapy following chemotherapy in patients with high-risk features on histo-pathology after radical surgery for transitional cell carcinoma of urinary bladder

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: All patients should have undergone radical cystoprostatectomy for bladder cancer Patients with any of the below high risk features on histolopathology * Lymph Node positive with or without perinodal extension (PNE) * Cut-margin positive, * pT3 and pT4 disease, * Number of nodes dissected at surgery \< 10 All patients irrespective of the final pathology if they have received neo-adjuvant chemotherapy prior to surgery for any of the following T3 T4 stage N1-3 stage No evidence of distant metastasis including para-aortic nodal metastasis KPS ≥ 70 Signed study specific consent form Adequate hepatic, renal and hematologic parameters Exclusion Criteria: * Contraindication to pelvic radiotherapy like inflammatory bowel disease * Uncontrolled diabetes or hypertension * Uncontrolled cardiac or respiratory co morbidity * Prior history of therapeutic irradiation to pelvis * Patient unwilling and unreliable for follow up and QoL

Primary outcome measure(s)

Improvement in loco-regional relapse free survival (LRFS) — 2 year

Trial sites (1)

Facility	City	Region	Status
Tata Memorial Centre	Mumbai	Maharashtra

More Tata Memorial Centre trials in India

Assessment of the Breast Cosmesis Using Deep Neural Networks: an Exploratory Study (ABCD) Recruiting

Radiation Therapy in Unresectable Gall Bladder Cancer Recruiting

Study to Evaluate the Safety and Effectiveness of Withaferin A as a Treatment to Prevent GvHD in Transplant Patients Recruiting

Effect of Rifaximin on Gut Bacterial Flora Post Stem Cell Transplant in Patients With Acute Leukemia Recruiting

Randomized Trial of Prostate Only or Pelvic RT in High Risk Prostate Cancer Active, not recruiting

Other trials for the same condition

A Study of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-risk Non-muscle Invasive Bladder Cancer (HR-NMIBC) Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02951325 on ClinicalTrials.gov ↗ ← All trials in India