E3311
Phase II Randomized Trial of Transoral Surgery and Low-Dose Intensity Modulated Radiation Therapy in Resectable p16+ Locally Advanced Oropharynx Cancer: An ECOG-ACRIN Cancer Research Group Trial (E3311)
Phase 2N = 495NCT01898494
- Population
- Resectable stage III-IVa HPV-positive (p16-positive) oropharynx cancer
- Design
- Phase II trial of transoral surgery followed by risk-adapted postoperative treatment in resectable stage III-IVa (AJCC 7th edition) HPV-positive oropharynx cancer: transoral surgery was performed in 495 patients. Arm A (low risk) was observed; intermediate-risk patients were randomly allocated to 50 Gy (arm B) or 60 Gy (arm C) radiotherapy; arm D (high risk) received 66 Gy plus weekly cisplatin. Primary goals: feasibility of prospective multi-institutional study and 2-year progression-free survival; transoral surgery plus 50 Gy was considered promising if the lower limit of the exact 90% binomial confidence interval exceeded 85%. Arms A and D were assigned by pathological risk, not randomised.
- Primary endpoint
- PFS
- Arms
- Arm A: low risk, observation (experimental, n = 38): Observation after transoral surgery
- Arm B: intermediate risk, 50 Gy (experimental, n = 100): Postoperative radiotherapy 50 Gy
- Arm C: intermediate risk, 60 Gy (control, n = 108): Postoperative radiotherapy 60 Gy
- Arm D: high risk, 66 Gy plus cisplatin (experimental, n = 113): Postoperative radiotherapy 66 Gy plus weekly cisplatin
- People
- Ferris RL, ECOG-ACRIN Cancer Research Group
Δ 24-month PFS+0.9 points
Show the numbers
| Endpoint | Analysis | Arm A: low risk, observation / Arm B: intermediate risk, 50 Gy / Arm D: high risk, 66 Gy plus cisplatin | Arm C: intermediate risk, 60 Gy | Effect |
|---|---|---|---|---|
| PFS359 evaluable patients (eligible and treated) | primarymedian follow-up 35.2 monthsFerris 2022 | 96.9% at 2 y | 96% at 2 y | 359 evaluable patients. Intervals are exact 90% binomial or 90% CIs, not 95%: arm A 91.9 to 100, arm B 91.3 to 98.6, arm C 92.8 to 99.3, arm D 86.2 to 95.4. Arms B and C were randomised; arms A and D were assigned by risk. |
| Endpoint | Analysis | Arm A: low risk, observation / Arm B: intermediate risk, 50 Gy / Arm D: high risk, 66 Gy plus cisplatin | Arm C: intermediate risk, 60 Gy | Effect |
|---|---|---|---|---|
| PFS359 evaluable patients (eligible and treated) | primarymedian follow-up 35.2 monthsFerris 2022 | 96.9% at 2 y | 96% at 2 y | 359 evaluable patients. Intervals are exact 90% binomial or 90% CIs, not 95%: arm A 91.9 to 100, arm B 91.3 to 98.6, arm C 92.8 to 99.3, arm D 86.2 to 95.4. Arms B and C were randomised; arms A and D were assigned by risk. |
Appears in
Sources
Ferris RL, Flamand Y, Weinstein GS, Li S, Quon H, Mehra R, et al. Phase II Randomized Trial of Transoral Surgery and Low-Dose Intensity Modulated Radiation Therapy in Resectable p16+ Locally Advanced Oropharynx Cancer: An ECOG-ACRIN Cancer Research Group Trial (E3311). J Clin Oncol. 2022;40(2):138-149.