Health Condition 1: null- All patients should have undergone radical cystoprostatectomy for bladder cancer Health Condition 2: N328- Other specified disorders of bladder
Conditions
Interventions
Intervention1: Radiation therapy in patients having undergoneCystectomy f/b (Neo) adjuvant chemotherapy: Study design has two arms Arm 1 (test arm): Cystectomy + (Neo) adjuvant chemotherapy + Radiothe
Sponsors
Tata Memorial Centre Department of Atomic Energy Clinical Trial Centre
Eligibility
Inclusion criteria
Inclusion criteria: All patients should have undergone radical cystoprostatectomy for bladder cancer Patients with any of the below high risk features on histolopathology 1.Lymph Node positive with or without perinodal extension (PNE) 2.Cut-margin positive, 3.pT3 and pT4 disease, 4.Number of nodes dissected at surgery 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
Exclusion criteria
Exclusion criteria: o Contraindication to pelvic radiotherapy like inflammatory bowel disease o Uncontrolled diabetes or hypertension o Uncontrolled cardiac or respiratory co morbidity o Prior history of therapeutic irradiation to pelvis o Patient unwilling and unreliable for follow up and QoL
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in loco-regional relapse free survival(LRFS)Timepoint: Two years | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Disease free survival (DFS), â?¢ Overall survival(OS), â?¢ Acute toxicity, â?¢ Late toxicity, â?¢ QOL Timepoint: two and five years | — |
Countries
India
Contacts
Public ContactDr Vedang Murthy
ACTREC, Tata Memorial Centre
Outcome results
None listed