Bladder Cancer Adjuvant Radiotherapy Trial

Phase 3

Active, not recruiting

• Conditions: Urothelial Carcinoma Bladder; Bladder Cancer
• Interventions: Other: Adjuvant RT

• Registration Number: NCT02951325
• Lead Sponsor: Tata Memorial Centre

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

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:

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.

Study Timeline

• Study Start: 2016-06-02
• Study First Submitted: 2016-10-26
• Study First Submitted QC: 2016-10-28
• Study First Posted: 2016-11-01
• Primary Completion: 2024-05-08
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-13
• Study Completion: 2030-04-13

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 153

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test	Adjuvant RT	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.

Primary Outcome Measures

Name	Time	Method
Improvement in loco-regional relapse free survival (LRFS)	2 year

Secondary Outcome Measures

Name	Time	Method
QOL	2 years	FACT questionnaire will be used to assess QOL.
RT toxicity (acute and late)	6 months and 2 years	RT toxicity will be measured using RTOG and CTCAE grading scale
Patterns of failure	2 years	The local, regional and distant metastasis rates will be assessed with 6 monthly CT scan
Disease free survival (DFS)	two and five years
Overall survival(OS)	two and five years

Trial Locations

Locations (1)

Tata Memorial Centre; 🇮🇳 Mumbai, Maharashtra, India