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


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