Bladder Cancer Clinical Trial
— BARTOfficial title:
Prospective Randomized Trial of Adjuvant Radiotherapy Following Surgery and Chemotherapy in Muscle Invasive Transitional Cell Carcinoma of Urinary Bladder
NCT number | NCT02951325 |
Other study ID # | BART |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2016 |
Est. completion date | April 13, 2023 |
Aim and objectives: 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 transitional cell carcinoma of urinary bladder
Status | Recruiting |
Enrollment | 153 |
Est. completion date | April 13, 2023 |
Est. primary completion date | April 13, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
India | Tata Memorial Centre | Mumbai | Maharashtra |
Lead Sponsor | Collaborator |
---|---|
Tata Memorial Centre |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Improvement in loco-regional relapse free survival (LRFS) | 2 year | ||
Secondary | Disease free survival (DFS) | two and five years | ||
Secondary | Overall survival(OS) | two and five years | ||
Secondary | RT toxicity (acute and late) | RT toxicity will be measured using RTOG and CTCAE grading scale | 6 months and 2 years | |
Secondary | QOL | FACT questionnaire will be used to assess QOL. | 2 years | |
Secondary | Patterns of failure | The local, regional and distant metastasis rates will be assessed with 6 monthly CT scan | 2 years |
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