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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 (>1 mm)
66 Gy with weekly cisplatin (40 mg/m2 weekly)
ADEPT [50] Phase III
RCT
WashU
Post trans-oral surgery
Stage III, IV
+ENE, R0
None Randomized: 60 Gy +/- cisplatin (40 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 (<1 mm)
Negative marginal biopsy
+ENE
Randomized: 60 Gy +/- cisplatin (40 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 (<1 mm)
50 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
  1. R0 negative surgical margin, R1/R2 positive surgical margin, PNI perineural invasion, LVI lymphovascular invasion, ENE extranodal extension, LN+ involved lymph nodes, SCV nodes supraclavicular lymph nodes