Preliminary Toxicity Analysis of 3DCRT versus IMRT on the High Dose Arm of the RTOG 0126 Prostate Cancer Trial
Abstract
Purpose A Preliminary report of clinical and treatment factors associated with toxicity in men receiving high dose radiation (RT) on a phase III dose escalation trial. Methods and Materials Trial was initiated with 3 dimensional RT (3DCRT) and amended after 1 year to allow intensity modulated RT (IMRT). Patients treated with 3DCRT received 55.8Gy to a planning target volume that included the prostate and seminal vesicles then 23.4Gy to prostate only. IMRT patients were treated to the prostate and proximal seminal vesicles to 79.2Gy. CTC v2.0 and RTOG/EORTC late morbidity scores were used for acute and late effects. Results 748 of 763 patients randomized to the 79.2 Gy arm of RTOG 0126 were eligible and evaluable. 491 and 257 were treated with 3DCRT and IMRT, respectively. For both bladder and rectum, the volumes receiving 65, 70, and 75Gy were significantly lower with IMRT (all p=15% are associated with G2+ rectal toxicity (p=0.034). Conclusions IMRT is associated with a significant reduction in acute G2+ GI/GU toxicity. There is a trend for a clinically meaningful reduction in late G2+ GI toxicity with IMRT. The occurrence of acute GI toxicity and large (>15%) volumes of rectum >70Gy are associated with late rectal toxicity.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 748 participants or records.
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