NRG-HN002
Reduced-Dose Radiation Therapy for HPV-Associated Oropharyngeal Carcinoma (NRG Oncology HN002)
Phase 2N = 306NCT02254278
- Population
- p16-positive oropharyngeal squamous cell carcinoma, T1-T2 N1-N2b or T3 N0-N2b, 10 pack-years of smoking or fewer
- Design
- Randomised phase II trial: 306 patients with p16-positive T1-T2 N1-N2b M0 or T3 N0-N2b M0 oropharyngeal squamous cell carcinoma (7th edition staging) and 10 pack-years of smoking or fewer were randomly assigned and eligible to 60 Gy IMRT over 6 weeks with concurrent weekly cisplatin, or 60 Gy IMRT over 5 weeks. To be considered for a phase III study an arm had to show a 2-year PFS rate superior to a historical control rate of 85% and a 1-year mean MDADI composite score of 60 or more. The arms were each compared with these benchmarks, not with a standard-dose control.
- Primary endpoint
- PFS, Swallowing-related quality of life (MDADI)
- Arms
- 60 Gy IMRT with weekly cisplatin (experimental): 60 Gy IMRT over 6 weeks with concurrent weekly cisplatin
- 60 Gy IMRT over 5 weeks (experimental): 60 Gy IMRT over 5 weeks
- People
- Yom SS, NRG Oncology
Show the numbers
| Endpoint | Analysis | 60 Gy IMRT with weekly cisplatin / 60 Gy IMRT over 5 weeks | Control | Effect |
|---|---|---|---|---|
| PFSRandomly assigned and eligible patients (306) | primaryYom 2021 | 90.5% at 2 y | — | P=0.04 (IMRT + C); 0.23 (IMRT alone)P-values test 2-year PFS against the historical control rate of 85%, not one arm against the other. |
| OSRandomly assigned and eligible patients (306) | primaryYom 2021 | 96.7% at 2 y | — | — |
| Severe adverse events (grade 3 or higher)Randomly assigned and eligible patients (306); acute adverse events | primaryYom 2021 | 79.6% | — | P<0.001Grade 3-4 acute adverse events (within 180 days of the end of treatment). |
| Severe adverse events (grade 3 or higher)Randomly assigned and eligible patients (306); late adverse events | primaryYom 2021 | 21.3% | — | P=0.56Grade 3-4 late adverse events. |
| Endpoint | Analysis | 60 Gy IMRT with weekly cisplatin / 60 Gy IMRT over 5 weeks | Control | Effect |
|---|---|---|---|---|
| PFSRandomly assigned and eligible patients (306) | primaryYom 2021 | 90.5% at 2 y | — | P=0.04 (IMRT + C); 0.23 (IMRT alone)P-values test 2-year PFS against the historical control rate of 85%, not one arm against the other. |
| OSRandomly assigned and eligible patients (306) | primaryYom 2021 | 96.7% at 2 y | — | — |
| Severe adverse events (grade 3 or higher)Randomly assigned and eligible patients (306); acute adverse events | primaryYom 2021 | 79.6% | — | P<0.001Grade 3-4 acute adverse events (within 180 days of the end of treatment). |
| Severe adverse events (grade 3 or higher)Randomly assigned and eligible patients (306); late adverse events | primaryYom 2021 | 21.3% | — | P=0.56Grade 3-4 late adverse events. |