Prospective randomized trial of Adjuvant radiotherapy following surgery and chemotherapy in muscle invasive transitional cell carcinoma of urinary bladder

Phase 3

• Conditions: Health Condition 1: null- All patients should have undergone radical cystoprostatectomy for bladder cancerHealth Condition 2: N328- Other specified disorders of bladder

• Registration Number: CTRI/2016/11/007451
• Lead Sponsor: Tata Memorial Centre Department of Atomic Energy Clinical Trial Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 153

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 < 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

Exclusion Criteria

oContraindication to pelvic radiotherapy like inflammatory bowel disease

oUncontrolled diabetes or hypertension

oUncontrolled cardiac or respiratory co morbidity

oPrior history of therapeutic irradiation to pelvis

oPatient unwilling and unreliable for follow up and QoL

Study & Design

• Study Type: Interventional
• Study Design: Not specified