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ACTIVE NOT RECRUITING
NCT02951325
PHASE3

Bladder Cancer Adjuvant Radiotherapy Trial

Sponsor: Tata Memorial Centre

View on ClinicalTrials.gov

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

Official title: Prospective Randomized Trial of Adjuvant Radiotherapy Following Surgery and Chemotherapy in Muscle Invasive Transitional Cell Carcinoma of Urinary Bladder

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

153

Start Date

2016-06-02

Completion Date

2030-04-13

Last Updated

2025-02-13

Healthy Volunteers

No

Interventions

OTHER

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.

Locations (1)

Tata Memorial Centre

Mumbai, Maharashtra, India