# RTOG 1016

Source: https://onco.cc/trials/rtog-1016/  
OnCo record `rtog-1016` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

RTOG 1016 tried to spare HPV-positive throat cancer patients the toxicity of cisplatin by using cetuximab instead, and found that survival was worse: cisplatin stays the standard.

## Summary

RTOG 1016 randomised 987 patients with HPV-positive oropharyngeal squamous cell carcinoma to accelerated radiotherapy with cisplatin or with cetuximab. Five-year overall survival was 84.6 percent with cisplatin and 77.9 percent with cetuximab, failing non-inferiority, and locoregional failure was higher with cetuximab; overall toxicity was similar (Gillison and colleagues, Lancet 2019). Together with De-ESCALaTE it closed the door on antibody substitution in this good-prognosis disease.

## Fields

- Kind: Trial
- Status: negative
- Last checked: 2026-09-17
- Tags: radiation-wave4
- Registry id: NCT01302834
- Phase: 3
- Setting: HPV-positive oropharyngeal cancer: radiotherapy with cetuximab versus radiotherapy with cisplatin
- Sponsor: NRG Oncology
- Enrolled: 987
- Result: 5-year overall survival 84.6% (cisplatin) vs 77.9% (cetuximab); non-inferiority not met.
- Outcomes: Overall survival at 5 years: Radiotherapy plus cisplatin 84.6% vs Radiotherapy plus cetuximab 77.9%

## Sources

- ClinicalTrials.gov NCT01302834: https://clinicaltrials.gov/study/NCT01302834
- Lancet 2019: https://doi.org/10.1016/S0140-6736(18)32779-X

## Connected records

- cancers: [Head and neck squamous cell carcinoma](https://onco.cc/cancers/head-and-neck/), [HPV-positive oropharyngeal cancer](https://onco.cc/cancers/hpv-positive-oropharyngeal-cancer/), [Oropharyngeal cancer (tonsil and base of tongue)](https://onco.cc/cancers/oropharyngeal-cancer/)
- technologies: [HPV DNA testing and self-sampling](https://onco.cc/technologies/hpv-testing/), [IMRT / IGRT (modern external beam)](https://onco.cc/technologies/imrt-igrt/)
- drugs: [Cetuximab](https://onco.cc/drugs/cetuximab/), [Cisplatin](https://onco.cc/drugs/cisplatin/)
- terms: [Chemoradiation (chemoradiotherapy, CRT)](https://onco.cc/terms/chemoradiation/)

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