Table 1 De-escalation trials in HPV-associated OPSCCA
From: Considerations in surgical versus non-surgical management of HPV positive oropharyngeal cancer
Trial | Phase | Population | Intervention | Primary outcome |
|---|---|---|---|---|
Surgical trials | ||||
 NCT01898494 ECOG 3311 | II | Stage III-Iva (no T1-2, N1) | Transoral surgery followed by risk stratification -Low: no adjuvant -Intermediate: 50 vs 60 Gy IMRT randomization -High: 66 Gy IMRT with weekly cisplatin (40 mg/m2) | 2 year DFS |
 NCT01932697 | II | <10 pack year smoker, must have one: T3/T4a, N2a-N3, ECE/PNI/LVI | Transoral surgery with negative margin followed by hyperfractionated IMRT + docetaxel | 2 year LRC/DFS |
 NCT01687413, ADEPT | III | T1-4a with negative margins and cervical metastasis with ECE | Transoral surgery followed by IMRT: randomized into 60 Gy alone vs with concurrent cisplatin (40 mg/m2) | 2 year DFS/LRC |
 NCT02215265, PATHOS | II/III | T1-3, N0-2b, <10 pack year smoker | Transoral surgery followed by risk stratification -Low: no adjuvant -Intermediate: 50 vs 60 Gy IMRT randomization -High: chemoradiation vs IMRT (60 Gy) randomization | 2 year PFS |
 NCT01590355, ORATOR | II | T1-2, N0-1 or N2b (up to 2 nodes); stratify groups by HPV status | Transoral surgery plus neck dissection vs IMRT +/- chemotherapy | 1 year QOL |
 EORTC 1420-HNCG-ROG | III | Stage I/II, HPV positive and negative | Transoral surgery plus neck dissection randomized vs IMRT | 1 year QOL |
 NCT02072148, SIRS | II | T1N0-2b, T2N0-2b; <20 pack year smoker (or >10 year smoke free) | Transoral surgery followed by risk stratification -Low: no adjuvant -Intermediate: 50 Gy IMRT -High: IMRT (56 Gy) + cisplatin (40 mg/m2) | 3 & 5 year DFS/LRC |
Non-surgical trials | ||||
 NCT01084083, ECOG 1308 | II | Stage III/IVa-b | Low dose IMRT (50 Gy) + cetuximab vs standard dose (60 Gy) | 2 year OS |
 NCT02254278, NRG HN002 | II | Stage III/IV (T1-2, N1-2b, or T3, N0-2b); <10 pack year smoker | IMRT (60 Gy) +/- cisplatin | 2 year PFS |
 NCT01302834, RTOG 1016 | III | Stage III/IV | IMRT (60 Gy) with high dose cisplatin vs IMRT with cetuximab | 5 year OS |
 NCT01874171, De-ESCALATE | III | T3N0-T4N0 and T1N1-T4N3), <10 pack year smoker | Standard dose IMRT (70 Gy) with cisplatin (100 mg/m2) vs IMRT + cetuximab | Severe toxicity |
 NCT01855451, TROG 12.01 | III | Stage III (except T1-2 N1), stage IVa (except T4), <10 pack year smoker (if >10 pack year, must be N0-N2a) | Standard dose radiation (70 Gy) with cisplatin (40 mg/m2) vs cetuximab | Symptom severity |
 NCT01663259, University of Michigan | II | Stage III/IV (no T4,N3), <10 pack year smoker | Standard dose radiation (70 Gy) + cetuximab | Recurrence rate |
 NCT01530997, Lineberger Comprehensive Cancer Center | II | T1-3, N0-2c; <10 pack year smoker (or > 5 years smoke free) | IMRT (54-60 Gy) with cisplatin (30 mg/m2) | Complete pathologic response |
 NCT01088802, Kimmel Comprehensive Cancer Center | II | T1-3, any N (resectable) | IMRT, dose de-escalation from 70 Gy to 63 Gy, and from 58.1 Gy to 50.75 Gy, while receiving cisplatin | Severe toxicity, QOL |