Clinical trial · Interventional
Bladder Cancer Adjuvant Radiotherapy Trial
Prospective Randomized Trial of Adjuvant Radiotherapy Following Surgery and Chemotherapy in Muscle Invasive Transitional Cell Carcinoma of Urinary Bladder
NCT02951325CI-TRIAL-00085928BARTactive not recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Urothelial Carcinoma Bladder | Bladder Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adjuvant RT | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Standard
- description
- Surgery +/- chemotherapy only * Surgery (Standard/routine care) Cysto-prostatectomy and pelvic nodal dissection as part of their standard care. * Chemotherapy All patients following cysto-prostatectomy (inclusive of those received neo-adjuvant chemotherapy) will receive upto 4 cycles of adjuvant chemotherapy if medically fit for the same. The chemotherapy regimen, doses and schedule will be as per standard institutional practice. No concomitant chemotherapy with radiotherapy is recommended. No radiation therapy will be given.
- type
- EXPERIMENTAL
- label
- Test
- description
- Surgery +/- chemotherapy as per standard arm and Radiation therapy as experimental intervention Radiation Therapy: All patients will be treated with conformal radiotherapy technique with intensity modulated radiotherapy with or without image guidance. The radiotherapy will start within 8 weeks from the date of surgery if adjuvant chemotherapy has not been planned. The radiotherapy will start within 4 weeks from the date of last chemo cycle, in patients who will be given adjuvant chemotherapy. Dose Prescription: •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 54-56 Gy in 28 fractions depending on the constraints achieved during planning. Patient assessments: Clinical assessment for toxicity evaluation and disease status. QOL evaluation of the patients.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDMurthy V, Maitre P, Singh M, Pal M, Arora A, Pujari L, Kapoor A, Pandey H, Sharma R, Gudipudi D, Joshi A, Prabhash K, Noronha V, Menon S, Mehta P, Bakshi G, Prakash G. Study Protocol of the Bladder Adjuvant RadioTherapy (BART) Trial: A Randomised Phase III Trial of Adjuvant Radiotherapy Following Cystectomy in Bladder Cancer. Clin Oncol (R Coll Radiol). 2023 Sep;35(9):e506-e515. doi: 10.1016/j.clon.2023.04.010. Epub 2023 May 5. PMID 37208232
- RESULTMurthy V, Maitre P, Bakshi G, Pal M, Singh M, Sharma R, Gudipudi D, Pujari L, Pandey H, Bandekar B, Joseph D, Krishnatry R, Phurailatpam R, Kannan S, Arora A, Misra A, Joshi A, Noronha V, Prabhash K, Menon S, Prakash G. Bladder Adjuvant Radiation Therapy (BART): Acute and Late Toxicity From a Phase III Multicenter Randomized Controlled Trial. Int J Radiat Oncol Biol Phys. 2025 Mar 1;121(3):728-736. doi: 10.1016/j.ijrobp.2024.09.040. Epub 2024 Sep 29. PMID 39353477
- DERIVEDMurthy V, Maitre P, Pal M, Arora A, Phurailatpam R, Sharma R, Gudipudi D, Rajappa S, Pujari L, Bandekar B, Joseph D, Kannan S, Krishnatry R, Misra A, Joshi A, Noronha V, Prabhash K, Menon S, Bakshi G, Prakash G. Bladder Adjuvant Radiotherapy: Phase III Multicenter Randomized Controlled Trial of Adjuvant Radiotherapy or Observation for Postcystectomy Muscle-Invasive Bladder Cancer. J Clin Oncol. 2026 Jul;44(19):1812-1821. doi: 10.1200/JCO-25-02093. Epub 2026 May 21. PMID 42166701