A Phase 3 interventional study of Adjuvant RT in Bladder Cancer and Urothelial Carcinoma Bladder, sponsored by Tata Memorial Centre. Active, not recruiting at 1 site in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-13.
Sponsored by Tata Memorial Centre · Phase 3, Interventional, and Treatment
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
Treatment details:
Surgery(Standard/routine care) All patients would have undergone radical surgery in the form of a cysto-prostatectomy and pelvic nodal dissection as part of their standard care. Patients would also have a urinary diversion (Ileostomy) or a continent neo bladder.
Chemotherapy All patients following cysto-prostatectomy will receive upto 4 cycles of adjuvant chemotherapy if medically fit for the same. Those patients who received neoadjuvant chemotherapy, will receive additional chemotherapy cycle after surgery to a total of 4 cycles if found suitable. The chemotherapy regimen, doses and schedule will be as per standard institutional practice using Platinum based chemotherapy. No concomitant chemotherapy with radiotherapy is recommended.
Radiation therapy:
All patients will be treated with conformal radiotherapy technique with intensity modulated radiotherapy with or without image guidance. The radiotherapy will start within maximum of 8 weeks from the date of surgery if adjuvant chemotherapy has not been planned. If adjuvant chemo planned the patients will receive radiotherapy within 4 weeks of the last chemo cycle.
Dose Prescription:
50.4Gray (Gy) in 28fractions (1.8Gy/#) will be prescribed for the nodal PTV. In case of R1 and/or R2 resection dose to the pelvic nodes and tumour bed may be increased to 54-56Gy in 28 fractions depending on the constraints achieved during planning.
Clinical assessment:
Toxicity will be assessed by
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All patients should have undergone radical cystoprostatectomy for bladder cancer Patients with any of the below high risk features on histolopathology
Exclusion Criteria:
Surgery +/- chemotherapy only * Surgery (Standard/routine care) Cysto-prostatectomy and pelvic nodal dissection as part of their standard care. * Chemotherapy All patients following cysto-prostatectomy (inclusive of those received neo-adjuvant chemotherapy) will receive upto 4 cycles of adjuvant chemotherapy if medically fit for the same. The chemotherapy regimen, doses and schedule will be as per standard institutional practice. No concomitant chemotherapy with radiotherapy is recommended. No radiation therapy will be given.
Surgery +/- chemotherapy as per standard arm and Radiation therapy as experimental intervention Radiation Therapy: All patients will be treated with conformal radiotherapy technique with intensity modulated radiotherapy with or without image guidance. The radiotherapy will start within 8 weeks from the date of surgery if adjuvant chemotherapy has not been planned. The radiotherapy will start within 4 weeks from the date of last chemo cycle, in patients who will be given adjuvant chemotherapy. Dose Prescription: •50.4 Gray (Gy) in 28 fractions (1.8Gy/#) will be prescribed for the nodal PTV. In case of R1 and/or R2 resection dose to the pelvic nodes and tumour bed may be increased to 54-56 Gy in 28 fractions depending on the constraints achieved during planning. Patient assessments: Clinical assessment for toxicity evaluation and disease status. QOL evaluation of the patients.
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.
Improvement in loco-regional relapse free survival (LRFS)
Time frame: 2 year
Disease free survival (DFS)
Time frame: two and five years
Overall survival(OS)
Time frame: two and five years
RT toxicity (acute and late)
RT toxicity will be measured using RTOG and CTCAE grading scale
Time frame: 6 months and 2 years
QOL
FACT questionnaire will be used to assess QOL.
Time frame: 2 years
Patterns of failure
The local, regional and distant metastasis rates will be assessed with 6 monthly CT scan
Time frame: 2 years
This study is active, not recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Tata Memorial Centre