Bladder CancerPhase 3BARTNCT02951325
Bladder Cancer Adjuvant Radiotherapy Trial
A Phase 3 study testing Adjuvant RT in people with Bladder Cancer and Urothelial Carcinoma Bladder, run by Tata Memorial Centre at 1 site in India.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer, Urothelial Carcinoma Bladder
- What is being tested?
- Adjuvant RT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteIndia
- Study dates
- 2 Jun 2016to 13 Apr 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Trial of Adjuvant Radiotherapy Following Surgery and Chemotherapy in Muscle Invasive Transitional Cell Carcinoma of Urinary Bladder
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
Read the detailed description
Treatment details:
Surgery(Standard/routine care) All patients would have undergone radical surgery in the form of a cysto-prostatectomy and pelvic nodal dissection as part of their standard care. Patients would also have a urinary diversion (Ileostomy) or a continent neo bladder.
Chemotherapy All patients following cysto-prostatectomy will receive upto 4 cycles of adjuvant chemotherapy if medically fit for the same. Those patients who received neoadjuvant chemotherapy, will receive additional chemotherapy cycle after surgery to a total of 4 cycles if found suitable. The chemotherapy regimen, doses and schedule will be as per standard institutional practice using Platinum based chemotherapy. No concomitant chemotherapy with radiotherapy is recommended.
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 maximum of 8 weeks from the date of surgery if adjuvant chemotherapy has not been planned. If adjuvant chemo planned the patients will receive radiotherapy within 4 weeks of the last chemo cycle.
Dose Prescription:
50.4Gray (Gy) in 28fractions (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.
Clinical assessment:
- Toxicity will be assessed by
- Weekly physician assessment during RT with scoring of toxicity.
- RTOG toxicity criteria at baseline, 6-8 weeks post RT and at 3 monthly thereafter for 2 years and 6 monthly thereafter for 5 years.
- QOL will be assessed at baseline and 3-6 monthly thereafter
- Disease evaluation The first follow up all patients will be done at 6-8 week to assess toxicity. Clinical evaluation of the disease will be done at each follow up visits by clinical examination. CT scan of the abdomen and pelvis will be done 6 monthly from second visit onwards up to 2 years and 12 monthly thereafter or whenever clinically indicated as decided by the physician.
- Conditions
- Bladder Cancer, Urothelial Carcinoma Bladder
- Being tested
- Adjuvant RT
- Keywords
- adjuvant RT
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjuvant RTOther
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:
- Weekly RT with toxicity scoring.
- RTOG toxicity criteria at baseline, 6-8 weeks post RT and f/b 3 monthly x 2 years and 6 monthly x 5 years.
- QOL will be assessed at baseline f/b 3-6 monthly.
- Disease evaluation:
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Adjuvant RT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in loco-regional relapse free survival (LRFS)
Measured: 2 year
Secondary outcomes (5)
Disease free survival (DFS)
Measured: two and five years
Overall survival(OS)
Measured: two and five years
RT toxicity (acute and late)
RT toxicity will be measured using RTOG and CTCAE grading scale
Measured: 6 months and 2 years
QOL
FACT questionnaire will be used to assess QOL.
Measured: 2 years
Patterns of failure
The local, regional and distant metastasis rates will be assessed with 6 monthly CT scan
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study start2 Jun 2016
- Primary completion8 May 2024
- Study completion13 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Tata Memorial CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 153 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tata Memorial Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Vedang Murthy, Tata Memorial Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02951325
- Sponsor's protocol ID
- BART
- Acronym
- BART
- Status last verified
- Feb 2025
- First submitted
- 26 Oct 2016
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 37208232Murthy 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.
PubMed 39353477Murthy 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.
PubMed 42166701
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial of Adjuvant Radiotherapy Following Surgery and Chemotherapy in Muscle Invasive Transitional Cell Carcinoma of Urinary Bladder
- ClinicalTrials.gov ID
- NCT02951325
- Acronym / sponsor ID
- BART / BART
- Conditions
- Bladder Cancer, Urothelial Carcinoma Bladder
- Keywords
- adjuvant RT
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 153 participants (estimated)
- Lead sponsor
- Tata Memorial CentreUniversity, hospital or other
- Study start
- 2 Jun 2016 (actual)
- Primary completion
- 8 May 2024 (actual)
- Study completion
- 13 Apr 2030 (estimated)
- First posted
- 1 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Treatment details:
Surgery(Standard/routine care) All patients would have undergone radical surgery in the form of a cysto-prostatectomy and pelvic nodal dissection as part of their standard care. Patients would also have a urinary diversion (Ileostomy) or a continent neo bladder.
Chemotherapy All patients following cysto-prostatectomy will receive upto 4 cycles of adjuvant chemotherapy if medically fit for the same. Those patients who received neoadjuvant chemotherapy, will receive additional chemotherapy cycle after surgery to a total of 4 cycles if found suitable. The chemotherapy regimen, doses and schedule will be as per standard institutional practice using Platinum based chemotherapy. No concomitant chemotherapy with radiotherapy is recommended.
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 maximum of 8 weeks from the date of surgery if adjuvant chemotherapy has not been planned. If adjuvant chemo planned the patients will receive radiotherapy within 4 weeks of the last chemo cycle.
Dose Prescription:
50.4Gray (Gy) in 28fractions (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.
Clinical assessment:
- Toxicity will be assessed by
- Weekly physician assessment during RT with scoring of toxicity.
- RTOG toxicity criteria at baseline, 6-8 weeks post RT and at 3 monthly thereafter for 2 years and 6 monthly thereafter for 5 years.
- QOL will be assessed at baseline and 3-6 monthly thereafter
- Disease evaluation The first follow up all patients will be done at 6-8 week to assess toxicity. Clinical evaluation of the disease will be done at each follow up visits by clinical examination. CT scan of the abdomen and pelvis will be done 6 monthly from second visit onwards up to 2 years and 12 monthly thereafter or whenever clinically indicated as decided by the physician.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Adjuvant RTSurgery +/- 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adjuvant RTRadiation 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. | Other | Test |
Primary outcome
Improvement in loco-regional relapse free survival (LRFS)
Time frame: 2 year
5 secondary outcomes
Disease free survival (DFS)
Time frame: two and five years
Overall survival(OS)
Time frame: two and five years
RT toxicity (acute and late)
Time frame: 6 months and 2 years
QOL
Time frame: 2 years
Patterns of failure
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Background: PubMed 37208232Murthy 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.
- Results publication: PubMed 39353477Murthy 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.
- Derived from this study: PubMed 42166701Murthy 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Adjuvant RT in people with Bladder Cancer and Urothelial Carcinoma Bladder, run by Tata Memorial Centre at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in loco-regional relapse free survival (LRFS) (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02951325, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.