Post-operative Concurrent Chemo-radiotherapy Versus Post-operative Radiotherapy for Cancer of the Head and Neck
Summary
The primary objective of the trial is to determine, in patients who have undergone surgery with curative intent for high-risk CSCC of the head and neck, whether there is a difference in time to loco-regional relapse between patients treated with post-operative concurrent chemo-radiotherapy ,consisting of Carboplatin, and post-operative radiotherapy alone. The target sample size for the trial is 266 patients and will take 3-4 years to accrue, based on an anticipated accrual of 80 patients/year. A further 2 years follow up is required.
Timeline
- Start
- 2005-04
- Primary completion
- 2016-03
- Completion
- 2016-03-31
Outcome
Missed primary endpoint
paper hazard ratio, 0.84; 95% CI, 0.46 to 1.55; P = .58 PMID 29537906 ↗
paper Although surgery and postoperative RT provided excellent FFLRR, there was no observed benefit with the addition of weekly carboplatin. PMID 29537906 ↗
Publications
- Porceddu SV, Connolly E, Bressel M, Wratten C, Liu HY, Rischin D. Prognostic Subgroups for Disease-Free Survival With Cutaneous Squamous Cell Carcinoma of the Head and Neck: A Secondary Analysis of a Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2025 Oct 1;151(10):938-945. doi: 10.1001/jamaoto.2025.2110.
- Porceddu SV, Bressel M, Poulsen MG, Stoneley A, Veness MJ, Kenny LM, Wratten C, Corry J, Cooper S, Fogarty GB, Collins M, Collins MK, Macann AMJ, Milross CG, Penniment MG, Liu HY, King MT, Panizza BJ, Rischin D. Postoperative Concurrent Chemoradiotherapy Versus Postoperative Radiotherapy in High-Risk Cutaneous Squamous Cell Carcinoma of the Head and Neck: The Randomized Phase III TROG 05.01 Trial. J Clin Oncol. 2018 May 1;36(13):1275-1283. doi: 10.1200/JCO.2017.77.0941. Epub 2018 Mar 14.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carboplatin | Small molecule | 2 unknown | Intravenous |