Table 4 Active Phase II/III Trials of Surgically-treated HPV-OPC
From: De-intensification of adjuvant therapy in human papillomavirus-associated oropharyngeal cancer
Trial | Details | Inclusion Criteria | Stratify | Definition | Treatment |
|---|---|---|---|---|---|
ECOG 3311 [33] | Phase II RCT Multi-site | Post trans-oral surgery Stage III, IVA, IVB | Low | R0 0–1 LN+ -ECE | Observation |
Intermediate | R0 2–4 LN+ +ENE (≤1 mm) | Randomized: 50 in 25 fx Gy vs 60 Gy in 30 fx | |||
High | R1-2 5+ LN+ +ENE (>1Â mm) | 66Â Gy with weekly cisplatin (40Â mg/m2 weekly) | |||
ADEPT [50] | Phase III RCT WashU | Post trans-oral surgery Stage III, IV +ENE, R0 | None | Randomized: 60Â Gy +/- cisplatin (40Â mg/m2 weekly) | |
PATHOS [51] | Phase II/III UK, multi-site T1–T3 N0-N2b | Post trans-oral surgery T1-3, N1-2b | Low | T1-T2 | Observation |
Intermediate | T3 T1-T2 with:  • N2a/2b  • PNI  • LVI  • Close margins (1–5 mm) | Randomized: 50 Gy in 25 fx vs 60 Gy in 30 fx | |||
High | Positive margin (<1Â mm) Negative marginal biopsy +ENE | Randomized: 60Â Gy +/- cisplatin (40Â mg/m2 weekly) | |||
SIRS [52] | Phase II Mount Sinal | Post-surgery T1N1-2b or T2N0-2b | Low | R0 -LVI, -PNI, no LN+ | observation |
Intermediate | R0 +LVI +PNI <3 LN+ ENE (<1Â mm) | 50Â Gy | |||
High | R1/R2 3+ LN+ ENE (≥1 mm) Matted or SCV nodes | 56 Gy with cisplatin (40 mg/m2 weekly) | |||
Mayo Clinic [41] | Phase II | Post-surgery Stage I-IVB R0 resection | At least one of following:  • LN > 3 cm  • >1 LN+  • PNI  • LVI  • T3 or microscopic T4a  • +ENE | Concurrent chemoradiation: Accelerated/hyperfractionated: 36 Gy in 20 fractions  • BID 5 days/week, days 1-12  • Concurrent docetaxel | |
University of Pennsylvania [43] | Phase II | Post-TORS and Selective Neck Dissection pT1-T2, N2a-c | Notable exclusion criteria:  • Positive or microscopically positive surgical margins (negative or close (<2 mm) margins of primary cancer  • PNI of primary cancer | All trial patients forgo adjuvant radiotherapy to the primary cancer | |