RTOG 0529 — RTOG 0529: A Phase 2 Evaluation of Dose-Painted Intensity Modulated Radiation Therapy in Combination With 5-Fluorouracil and Mitomycin-C for the Reduction of Acute Morbidity in Carcinoma of the Anal Canal

Phase 2 · 2013 · Anal Cancer

Design

Single-arm multi-institutional phase 2 trial of dose-painted IMRT with concurrent 5-fluorouracil and mitomycin-C, with acute toxicity compared to the 5-FU/mitomycin plus conventional 3D chemoradiation arm of RTOG 9811.

Population

52 evaluable patients with T2-T4 N0-N3 M0 squamous cell carcinoma of the anal canal.

Primary Endpoint

Reduction in acute grade 2+ combined gastrointestinal and genitourinary toxicity

Key Result

Dose-painted IMRT significantly reduced acute grade 3+ dermatologic (23% vs 49%, P<0.001) and gastrointestinal (21% vs 36%, P=0.008) toxicity versus RTOG 9811, though the primary endpoint of reduced grade 2+ GI/GU toxicity was not met, while maintaining comparable disease control.

Guideline Impact

IMRT adopted as standard radiotherapy technique for anal cancer (NCCN guidelines)