Prospective Randomized Trial of Adjuvant Radiotherapy Following Surgery and Chemotherapy in Muscle Invasive Transitional Cell Carcinoma of Urinary Bladder
Condition: Bladder Cancer, Urothelial Carcinoma Bladder
Study Type: Interventional
Clinical Trials Identifier NCT 8-digits: NCT02951325
Sponsor: Tata Memorial Centre
Eligibility:
- Age: minimum 18 Years maximum N/A
- Gender: All
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
View trial on ClinicalTrials.gov