Ghi 2017.

Study characteristics
Methods	Randomised controlled trial conducted in: Italy Number of centres: 48 Recruitment period: January 2003 to January 2006 Funding source: Sanofi Aventis, AVAPO Trial identification number: NCT01086826
Participants	Inclusion: adults (age > 18 years) with diagnosis of histologically/cytologically‐confirmed, previously untreated stage III/IV locally advanced squamous cell carcinoma of the head and neck (oral cavity, oropharynx, hypopharynx). Included patients were of Eastern Cooperative Oncology Group Performance Status 0‐1 with normal haematological, renal and hepatic function and a life‐expectancy of > 6 months. Patients must have been deemed unsuitable for radical surgery for technical reasons or low surgical curability. Exclusion: peripheral neuropathy or altered hearing > grade 2, weight loss > 20% in the preceding 3 months or deemed unresectable due to "medical conditions" 272 patients were evaluable.
Interventions	Comparison 1: Induction chemotherapy followed by locoregional treatment (LRT) versus LRT alone Gr A (n = 206): Induction chemotherapy with three cycles of docetaxel (75 mg/m2), cisplatin (80 mg/m2) and 5‐fluorouracil (800 mg/m2 on day 1‐4) followed by concurrent chemoradiotherapy with either: a) two cycles of cisplatin (20 mg/m2) and 5‐fluorouracil (800 mg/m2 on day 1‐4) in week 1 and 6 of radiation therapy or; b) weekly cetuximab (begin with loading dose 400 mg/m2 followed by 250 mg/m2 weekly during radiation therapy). Radiation therapy was 70 Gy delivered 2 Gy per day, 5 days a week. Gr B (n = 208): Concurrent chemoradiotherapy with either: a) two cycles of cisplatin (20 mg/m2) and 5‐fluorouracil (800 mg/m2 on day 1‐4) in week 1 and 6 of radiation therapy or; b) weekly cetuximab (begin with loading dose 400 mg/m2 followed by 250 mg/m2 weekly during radiation therapy). Radiation therapy was 70 Gy delivered 2 Gy per day, 5 days a week.
Outcomes	Overall survival, response rate, locoregional control rate, progression‐free survival
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated random sequence generation
Allocation concealment (selection bias)	Low risk	Reported allocation concealment
Blinding of participants?	Unclear risk	No blinding of participants
Blinding of carers?	Unclear risk	No blinding of carers
Blinding of outcome assessors?	Unclear risk	Unclear if outcome assessors blinded
Incomplete outcome data addressed?	Low risk	Outcome data available for nearly all participants
Free of selective reporting?	Low risk	All outcomes reported
Free of other bias?	Low risk	No other bias identified