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

Phase 3

Recruiting

Conditions: 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: This trial aims to evaluate the role of adjuvantradiotherapy following chemotherapy in patients with high-risk features onhisto-pathology after radical surgery for carcinoma of urinary bladder. All patients will be served the informedconsent form before the enrollment in the study and will be enrolled after fullcounseling and explanation of the treatment and its implications.

**StudyDesign and Randomization**

*Design:2 arm Prospective Randomized Trial*

Patients will be randomized to one of thesebelow mentioned arms using stratified block randomization method.

Arm 1 (test arm): Cystectomy + (Neo) adjuvantchemotherapy + **Radiotherapy**

Arm 2 (standard arm): Cystectomy + (Neo)adjuvant chemotherapy

**Stratification**

Nodalstatus ( Positive vs Negative)

Chemotherapy (Yes vs No)

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

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 â‰¥ 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

Primary Outcome Measures

Name	Time	Method
Improvement in loco-regional relapse free survival(LRFS)	Two years

Secondary Outcome Measures

Name	Time	Method
â€¢Disease free survival (DFS),	â€¢Overall survival(OS),

Trial Locations

Locations (3): Basavatarakam Indo-American Cancer Hospital and Research Institute
🇮🇳
Hyderabad, TELANGANA, India
Tata Memorial Centre
🇮🇳
(Suburban), MAHARASHTRA, India
Tata Memorial Centre,MPMMMCC& HBCH Varanasi
🇮🇳
Varanasi, UTTAR PRADESH, India
Basavatarakam Indo-American Cancer Hospital and Research Institute
🇮🇳Hyderabad, TELANGANA, India
Dr Rakesh Sharma
Principal investigator
7731037700
rakeshsharma217@gmail.com