NCT02951325Active, not recruitingPhase 3
Bladder Cancer Adjuvant Radiotherapy Trial
Prospective Randomized Trial of Adjuvant Radiotherapy Following Surgery and Chemotherapy in Muscle Invasive Transitional Cell Carcinoma of Urinary Bladder
Source: ClinicalTrials.gov · Last updated 13 Feb 2025
Brief summary (registry, in English)
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 (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 153 (estimated)
- First submitted
- 26 Oct 2016
- Start date
- 2 Jun 2016
- Primary completion date
- 8 May 2024
- Lead sponsor
- Tata Memorial Centre
- Diseases
- Bladder cancer
- NCT number
- NCT02951325
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 153
- From 2 Jun 2016 to the primary completion date, 8 May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior history of therapeutic irradiation to pelvis
Other illness
- Contraindication to pelvic radiotherapy like inflammatory bowel disease
- Uncontrolled diabetes or hypertension
- Uncontrolled cardiac or respiratory co morbidity
Other
- Patient unwilling and unreliable for follow up and QoL
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tata Memorial Centre Coordinator of this site? Confirm its status | Mumbai | India | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.