# RTOG 9501: postoperative concurrent radiotherapy and chemotherapy for high-risk head and neck squamous cell carcinoma

Source: https://onco.cc/key-papers/paper-cooper-rtog-9501-nejm-2004/  
OnCo record `paper-cooper-rtog-9501-nejm-2004` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

In this American trial, adding cisplatin to postoperative radiotherapy for high-risk head and neck cancer improved local control and disease-free survival but not overall survival, and doubled severe toxicity.

## Summary

Phase 3 trial of 459 patients with resected high-risk head and neck squamous cell carcinoma (two or more involved nodes, extracapsular extension or positive margins) randomised to postoperative radiotherapy alone or with concurrent cisplatin.

Locoregional control at two years was 82 versus 72 percent (hazard ratio 0.61) and disease-free survival was improved (hazard ratio 0.78), but overall survival did not differ significantly; grade 3 or worse adverse events were 77 versus 34 percent. Long-term follow-up confirmed benefit only in patients with extracapsular extension or positive margins.

## Fields

- Kind: Key paper
- Last checked: 2026-09-17
- Journal: New England Journal of Medicine
- Year: 2004
- DOI: 10.1056/NEJMoa032646
- Authors: Cooper JS, Pajak TF, Forastiere AA, et al.
- Findings: Two-year locoregional control 82 percent vs 72 percent.; Grade 3 or greater adverse events 77 percent vs 34 percent.
- What it means: With EORTC 22931, this trial defines who receives postoperative chemoradiation: patients with extranodal extension or positive margins, not those whose only risk factor is multiple nodes.
- Caveats: No overall survival benefit in the whole population.; Different high-risk definitions from the EORTC trial.

## Sources

- N Engl J Med 2004: https://doi.org/10.1056/NEJMoa032646
- PubMed: https://pubmed.ncbi.nlm.nih.gov/15128893/

## Connected records

- cancers: [Buccal mucosa and gingivobuccal cancer (oral cancer in India)](https://onco.cc/cancers/buccal-mucosa-cancer/), [HPV-negative head and neck squamous cell carcinoma (including HPV-negative oropharyngeal cancer)](https://onco.cc/cancers/hpv-negative-head-and-neck-cancer/), [Oral cavity cancer (mouth and tongue)](https://onco.cc/cancers/oral-cavity-cancer/)
- journals: [New England Journal of Medicine](https://onco.cc/journals/nejm/)

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