Bladder Cancer Adjuvant Radiotherapy Trial

NCT02951325 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: BART
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

Brief Summary

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

Bladder Cancer; Urothelial Carcinoma Bladder

Keywords

adjuvant RT

Outcome Measures

Primary Outcomes (1)

• Improvement in loco-regional relapse free survival (LRFS)

  2 year

Secondary Outcomes (5)

• Disease free survival (DFS)

  two and five years

• Overall survival(OS)

  two and five years

• RT toxicity (acute and late)

  6 months and 2 years

• QOL

  2 years

• Patterns of failure

  2 years

Study Arms (2)

Standard

NO INTERVENTION

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.

Test

EXPERIMENTAL

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.

Other: Adjuvant RT

Interventions

Adjuvant RT OTHER

Radiation therapy: All patients will be offered conformal technique with IMRT +/- image guidance. The adjuvant RT will start within 8 weeks from the date of surgery if chemotherapy not planned or 4 weeks from the date of last adjuvant chemo cycle. Dose: •50.4 Gray (Gy) in 28 fractions (1.8Gy/#) for the nodal PTV. For R1 and/or R2 resection increased to 54-56 Gy in 28 fractions based on the constraints achieved during planning. Patient assessments: Clinical: * Toxicity: 1. Weekly RT with toxicity scoring. 2. RTOG toxicity criteria at baseline, 6-8 weeks post RT and f/b 3 monthly x 2 years and 6 monthly x 5 years. 3. QOL will be assessed at baseline f/b 3-6 monthly. * Disease evaluation: i. first f/u all patients will be at 6-8 week to assess toxicity. ii. Clinical evaluation of the disease will be done at each f/u visit. iii. CT scan (abdomen and pelvis) 6 monthly from visit 2 onwards up to 2 years f/b 12 monthly or as clinically indicated.

Test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tata Memorial Centre: lead

Study Sites (1)

Tata Memorial Centre

Mumbai, Maharashtra, 410210, India

Location

Related Publications (2)

• Murthy 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 BACKGROUND

• Murthy 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 RESULT

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Radiation Oncologist

Study Record Dates

• First Submitted: October 26, 2016
• First Posted: November 1, 2016
• Study Start: June 2, 2016
• Primary Completion: May 8, 2024
• Study Completion (Estimated): April 13, 2030
• Last Updated: February 13, 2025

Record last verified: 2025-02

Locations

IN (1)