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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
  1. Abbreviations: ECOG Eastern cooperative oncology group, ADEPT adjuvant de-escalation, extracapsular spread, p16-positive, transoral, ECE extracapsular extension, DFS disease-free survival, LRC loco-regional control, HPV human papilloma virus, OPSCCA oropharyngeal squamous cell carcinoma, PATHOS postoperative adjuvant treatment for HPV-positive tumors, PFS progression free survival, IMRT intensity modulated radiation therapy, ORATOR oropharynx:radiotherapy vs transoral robotic surgery, QOL quality of life, EORTC European organization for research and treatment of cancer, HNCG-ROG head and neck cancer group- radiation oncology group, ECE extracapsular extension, PNI perineural invasion, LVI lymphovascular invasion, OS overall survival, RTOG radiation therapy oncology group, SIRS Sinai robotic surgery trial, TROG trans-tasman radiation oncology group