Bladder Cancer Adjuvant Radiotherapy Trial

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

153

Participants

Timeline

Start Date

June 2, 2016

Primary Completion Date

May 8, 2024

Study Completion Date

April 13, 2030

Conditions
Bladder CancerUrothelial Carcinoma Bladder
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."

Trial Locations (1)

410210

Tata Memorial Centre, Mumbai

All Listed Sponsors
lead

Tata Memorial Centre

OTHER