# NRG-HN002 & NRG-HN005 (HPV+ de-escalation)

Source: https://onco.cc/trials/nrg-hn002-hn005/  
OnCo record `nrg-hn002-hn005` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Attempts to give HPV-positive throat cancer patients less radiation fell short: the standard dose remained better, so de-escalation is not yet routine.

## Summary

HN002 (phase 2, 2021) found 60 Gy with weekly cisplatin met its acceptability threshold, but 60 Gy alone did not. HN005 (phase 2/3, presented 2025) was stopped after the de-intensified arms showed diminished progression-free survival while the 70 Gy control reached 2-year PFS of 98%. HPV status alone is an insufficient selector; ctHPV-DNA and imaging-response-adapted designs are the next approach.

## Fields

- Kind: Trial
- Status: mixed
- Last checked: 2026-09-07
- Tags: lesson:de-escalation-needs-better-selection
- Registry id: NCT03952585
- Phase: 2/3
- Setting: Low-risk HPV-positive oropharyngeal cancer: reduced-dose radiation (60 Gy) with or without cisplatin, or with nivolumab, vs standard 70 Gy chemoradiation
- Sponsor: NRG Oncology / NCI
- Result: HN005: de-escalated arms had worse PFS; control 2-year PFS 98%.
- Outcomes: HN005: progression-free survival at 2 years (phase II non-inferiority): 70 Gy + cisplatin (standard) 98.1% vs 60 Gy + cisplatin 88.6% vs 60 Gy + nivolumab 90.3%; HN002: progression-free survival at 2 years (randomised phase II vs 85% historical control): 60 Gy IMRT + weekly cisplatin 90.5% vs 60 Gy IMRT alone 87.6%
- Replication: HN005 confirmed the HN002 lesson in a randomised comparison: unselected dose de-escalation in HPV-positive oropharynx cancer costs disease control, consistent with the negative De-ESCALaTE and RTOG 1016 cetuximab-substitution trials.

## Sources

- ClinicalTrials.gov NCT03952585: https://clinicaltrials.gov/study/NCT03952585
- NRG Oncology HN005 summary: https://www.nrgoncology.org/Home/News/Post/treatment-de-intensification-for-early-stage-hpv-positive-oropharyngeal-cancer-nrg-hn005/

## 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: [IMRT / IGRT (modern external beam)](https://onco.cc/technologies/imrt-igrt/)
- companies: [NRG Oncology](https://onco.cc/companies/nrg-oncology/)
- terms: [HPV-positive (p16) head and neck cancer](https://onco.cc/terms/hpv-p16/), [Seamless, adaptive and Bayesian trial designs](https://onco.cc/terms/seamless-adaptive/)
- people: [Quynh-Thu Le](https://onco.cc/people/quynh-thu-le/)
- pairings: [Caution: de-escalating radiation on HPV status alone](https://onco.cc/pairings/hpv-deescalation-caution/)
- ideas: [ctHPV-DNA-adapted de-escalation of chemoradiation](https://onco.cc/ideas/idea-cthpv-adapted-deescalation/)
- roadmaps: [Radiotherapy roadmap: X-rays → shaped beams → fewer fractions, particles and FLASH](https://onco.cc/roadmaps/radiation-roadmap/)

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