Bladder Cancer Adjuvant Radiotherapy Trial

Bladder Cancer Clinical Trial

— BART  

Official title:

Prospective Randomized Trial of Adjuvant Radiotherapy Following Surgery and Chemotherapy in Muscle Invasive Transitional Cell Carcinoma of Urinary Bladder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02951325
• Other study ID #: BART
• Status: Recruiting
• Phase: N/A
• Start date: June 2016
• Est. completion date: April 13, 2023

Study information

• Verified date: October 2021
• Source: Tata Memorial Centre
• Contact: Vedang Murthy, MD
• Phone: 022-24177000
• Email: vmurthy[@]actrec.gov.in
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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: 1. Toxicity will be assessed by 1. Weekly physician assessment during RT with scoring of toxicity. 2. 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. 3. QOL will be assessed at baseline and 3-6 monthly thereafter 2. 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Bladder Cancer
• Carcinoma
• Urinary Bladder Neoplasms
• Urothelial Carcinoma Bladder

Intervention

Other:
• Adjuvant RT
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: 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.

Locations

Country	Name	City	State
India	Tata Memorial Centre	Mumbai	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Tata Memorial Centre

Country where clinical trial is conducted

India, 

Outcome

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