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Bladder Adjuvant Radiotherapy: Phase III Multicenter Randomized Controlled Trial of Adjuvant Radiotherapy or

Vedang Murthy¹, Priyamvada Maitre¹, Mahendra Pal²

¹Department of Radiation Oncology, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, India.

Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology

|May 21, 2026

Summary

This summary is machine-generated.

Adjuvant radiotherapy (RT) after chemotherapy and radical cystectomy (RC) significantly improves locoregional control in high-risk muscle-invasive bladder cancer (MIBC) patients. This treatment shows promising results for disease-free and overall survival without increased severe toxicity.

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Area of Science:

Uro-oncology
Radiation oncology
Clinical trial research

Background:

Muscle-invasive bladder cancer (MIBC) poses a significant treatment challenge, particularly in high-risk cases.
Adjuvant radiotherapy (RT) following radical cystectomy (RC) and chemotherapy is being investigated to improve outcomes.
Optimizing locoregional control is crucial for patients with high-risk MIBC post-RC.

Purpose of the Study:

To report the primary analysis of a phase III randomized trial evaluating adjuvant RT in high-risk MIBC.
To assess the efficacy and safety of adjuvant intensity-modulated radiotherapy (IMRT) after RC and chemotherapy.
To determine the impact of adjuvant RT on locoregional recurrence-free survival (LRFS) and other survival endpoints.

Main Methods:

A multicenter, phase III randomized trial assigned 153 high-risk, nonmetastatic MIBC patients to adjuvant RT or observation post-RC.
Patients received stratification based on nodal involvement and chemotherapy status; RT involved 50.4Gy in 28 fractions to the pelvic nodes.
Primary endpoint was 2-year LRFS; secondary endpoints included disease-free survival (DFS), bladder cancer-specific survival (BCSS), and overall survival (OS).

Main Results:

Adjuvant RT significantly improved 2-year LRFS compared to observation (87.1% vs. 76.0%, P=.04).
Trends favored RT for DFS (71.6% vs. 58.7%), BCSS (79.6% vs. 65.0%), and OS (70.4% vs. 57.4%), though not statistically significant.
Over 90% of patients received chemotherapy; no severe toxicity was reported with adjuvant pelvic IMRT.

Conclusions:

Adjuvant pelvic IMRT after RC and perioperative chemotherapy improves locoregional control in high-risk MIBC.
The findings suggest a potential benefit for adjuvant RT in improving oncological outcomes.
Adjuvant RT demonstrated an acceptable safety profile with no additional severe toxicity.