| CTRI Number |
CTRI/2016/11/007451 [Registered on: 08/11/2016] Trial Registered Retrospectively |
| Last Modified On: |
03/04/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Prospective randomized trial of Adjuvant radiotherapy following surgery and chemotherapy in muscle invasive transitional cell carcinoma of urinary bladder |
|
Scientific Title of Study
|
Bladder Cancer Adjuvant Radiotherapy Trial |
| Trial Acronym |
BART |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vedang Murthy |
| Designation |
Associate Professor and Radiation Oncologist |
| Affiliation |
ACTREC, Tata Memorial Centre |
| Address |
OPD 223, Homi Bhabha Block, Tata Memorial Hospital, Dr E. Borges marg, Parel Mumbai 400012
Mumbai (Suburban)
MAHARASHTRA
400012
India |
| Phone |
02224177028 |
| Fax |
|
| Email |
vedangmurthy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vedang Murthy |
| Designation |
Associate Professor and Radiation Oncologist |
| Affiliation |
ACTREC, Tata Memorial Centre |
| Address |
OPD 223, Homi Bhabha Block, Tata Memorial Hospital, Dr E. Borges marg, Parel Mumbai 400012
Mumbai (Suburban)
MAHARASHTRA
400012
India |
| Phone |
02224177028 |
| Fax |
|
| Email |
vedangmurthy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vedang Murthy |
| Designation |
Associate Professor and Radiation Oncologist |
| Affiliation |
ACTREC, Tata Memorial Centre |
| Address |
OPD 223, Homi Bhabha Block, Tata Memorial Hospital, Dr E. Borges marg, Parel Mumbai 400012
Mumbai (Suburban)
MAHARASHTRA
400012
India |
| Phone |
02224177028 |
| Fax |
|
| Email |
vedangmurthy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Centre, Department of Atomic Energy-Clinical Trial Centre |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Centre Department of Atomic Energy Clinical Trial Centre |
| Address |
Dr E. Borges Marg, Parel, Mumbai 400012, India |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rakesh Sharma |
Basavatarakam Indo-American Cancer Hospital and Research Institute |
Department of Uro-Oncology, Road no 10, Banjara Hills, Hyderabad
Hyderabad
TELANGANA |
7731037700
rakeshsharma217@gmail.com |
| Dr Vedang Murthy |
Tata Memorial Centre |
OPD 223, Dept of Radiation Oncology, Urology, Dr E Borges Marg, Parel Mumbai
Mumbai (Suburban)
MAHARASHTRA |
02224177028
vedangmurthy@gmail.com |
| DrLincoln Pujari |
Tata Memorial Centre,MPMMMCC& HBCH Varanasi |
Department Of Radiation Oncology, HBCH Varanasi
Varanasi
UTTAR PRADESH |
7735661666
drlincoln.pujari@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| ACTREC IEC-III |
Approved |
| IEC -BIACH & RI |
Approved |
| IEC-MPMMCC, HBCH Varanasi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
All patients should have undergone radical cystoprostatectomy for bladder cancer, (1) ICD-10 Condition: N328||Other specified disorders of bladder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Radiation therapy |
50.4 Gray (Gy) in 28 fractions (1.8Gy/#) will be prescribed for the nodal PTV. In case of R1
and/or R2 resection dose to the pelvic nodes and tumour bed may be increased to 54-56Gy
in 28 fractions depending on the constraints achieved during planning. |
| Comparator Agent |
Standard Arm |
No treatment |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in loco-regional relapse free survival(LRFS) |
Two years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Disease free survival (DFS),
• Overall survival(OS),
• Acute toxicity,
• Late toxicity,
• QOL
|
two and five years |
|
|
Target Sample Size
|
Total Sample Size="153"
Sample Size from India="153"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
12/07/2016 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="8"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
No publications as of now |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This trial aims to evaluate the role of adjuvant
radiotherapy following chemotherapy in patients with high-risk features on
histo-pathology after radical surgery for carcinoma of urinary bladder. All patients will be served the informed
consent form before the enrollment in the study and will be enrolled after full
counseling and explanation of the treatment and its implications. Study
Design and Randomization Design:
2 arm Prospective Randomized Trial Patients will be randomized to one of these
below mentioned arms using stratified block randomization method. Arm 1 (test arm): Cystectomy + (Neo) adjuvant
chemotherapy + Radiotherapy Arm 2 (standard arm): Cystectomy + (Neo)
adjuvant chemotherapy
Stratification Nodalstatus ( Positive vs Negative)
Chemotherapy (Yes vs No) |