Phase 3 randomized trial of topical steroid versus placebo for prevention of radiation dermatitis in head and neck cancer patients receiving chemoradiation
Abstract
PURPOSE
Radiation dermatitis is one of the most common acute toxicities induced by chemoradiotherapy (CRT) for head and neck cancer (HNC). The benefit of topical steroids in the management of radiation dermatitis is still unclear. This phase 3, multi-institutional, randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of topical steroids for radiation dermatitis in patients with locally advanced HNC receiving CRT.
METHODS AND MATERIALS
Eligible patients were scheduled to receive bilateral neck irradiation (≥ 66 Gy) with concurrent cisplatin (≥ 200 mg/m2) as definitive or postoperative CRT. Patients were randomly assigned to receive either topical steroid or placebo when radiation dermatitis grade 1 was observed or the total radiation dose reached 30 Gy. Basic skin care including gentle washing and moistening in the head and neck region was performed in both groups. The primary endpoint was frequency of ≥ grade 2 radiation dermatitis, in accordance with NCI Common Terminology Criteria for Adverse Events version 4.0. Grading of radiation dermatitis was performed by independent central review using photographs taken weekly.
RESULTS
A total of 211 patients were enrolled (intention to treat: steroid 101 and placebo 102). The frequency of ≥ grade 2 radiation dermatitis was not significantly reduced with the steroid [73.3% (95% CI: 64.6-81.9)] compared with that with the placebo [80.4% (95% CI: 72.7-88.1), p = 0.23], while steroid significantly…
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: 211 participants or records.
Read the paper
Related studies
- Preliminary Toxicity Analysis of 3DCRT versus IMRT on the High Dose Arm of the RTOG 0126 Prostate Cancer Trial
- Adaptive Radiotherapy for Head and Neck Cancer: Initial Clinical Outcomes from a Prospective Trial
- American Association of Physicists in Medicine Task Group 263: Standardizing Nomenclatures in Radiation Oncology
- Motion Management Strategies and Technical Issues Associated with Stereotactic Body Radiotherapy of Thoracic and Upper Abdominal Tumors: A Review from NRG Oncology
- High-dose-rate interstitial brachytherapy as a monotherapy for localized prostate cancer: treatment description and preliminary results of a phase I/II clinical trial
- Highly efficient training, refinement, and validation of a knowledge-based plan quality control system for radiotherapy clinical trials
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.