Role of human papillomavirus in oropharyngeal squamous cell carcinoma: A review

Table 1 Ongoing clinical trials pertaining to treatment of human papillomavirus-related oropharyngeal squamous cell carcinoma

Trial	Phase	Inclusion	Arm 1	Arm 2	Outcomes
RTOG 1016	III	p16 positive locally advanced oropharyngeal SCC	Radiation and concurrent chemotherapy	Radiation and concurrent cetuximab	Survival, toxicity, locoregional recurrence and quality of life
ECOG E1308	II	Stage III-IVa HPV positive oropharyngeal SCC	Complete response to induction chemotherapy and reduced dose radiation with concurrent cetuximab	Incomplete response to induction chemotherapy and standard dose radiation with concurrent cetuximab	Survival, toxicity, response, quality of life and biomarker correlation
De-ESCALaTE HPV	III	StageIII-IVa HPV positive oropharyngeal SCC	Cetuximab and concurrent radiotherapy	standard concurrent cisplatin and chemoradiotherapy	Morbidity, quality of life, cost, survival and recurrence
QUARTERBACK	III	Locally advanced HPV-16 positive oropharyngeal, unknown primary or nasopharyngeal SCC showing complete or partial response to induction therapy	Reduced dose radiation with cetuximab and chemotherapy	Standard dose radiation with chemotherapy	Survival, locoregional control, toxicity and biomarker correlation.
LCCC 1120	II	HPV positive and/or p16 positive low-risk oropharyngeal SCC	Decreased dose of radiation and chemotherapy	Standard radiation and chemotherapy	Pathological response rate, locoregional control, survival and quality of life
NCT01221753	II	Locally advanced HPV positive oropharyngeal SCC	Docetaxel/cisplatin/5-fluorouracil (TPF) induction chemotherapy followed by concurrent chemoradiation using a modified radiation dose	N/A	Locoregional control, survival and toxicity
SIRS	II	Early to mid-stage HPV positive oropharyngeal SCC who receive transoral robotic surgery plus a neck dissection, where clinically indicated	Observation only	Low dose postoperative radiation only Arm 3: Chemoradiation	Rates of locoregional control, overall survival and use of salvage chemoradiation in the observation group
TROG 12.01	III	HPV positive oropharyngeal SCC	Radiation and cetuximab	Radiation and cisplatin	Symptoms severity, swallowing, quality of life, toxicity, survival, locoregional recurrence
ADEPT	III	p16 positive oropharyngeal SCC that has undergone transoral resection with negative margins	Postoperative radiation alone	Postoperative radiation with cisplatin	Survival, locoregional control, toxicity and quality of life
NCT01088802	I/II	HPV positive T1-3 oropharyngeal SCC	De-escalated radiation from 70 Gy to 63 Gy with concurrent chemotherapy	De-escalated radiation from 58.1 Gy to 50.75 Gy with concurrent chemotherapy	Toxicity, quality of life and adverse events
ECOG E3311	II	Stage III-IVa HPV positive oropharyngeal SCC after transoral surgery and neck dissection with negative margins, no extracapsular spread and less than 4 lymph nodes involved	Transoral surgery with standard radiation	Transoral surgery with low-dose radiation	Survival, surgical complications, toxicity and swallowing

SCC: Squamous cell carcinoma; HPV: Human papillomavirus.