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. 2010 Dec 8;2010(12):CD006387. doi: 10.1002/14651858.CD006387.pub2

Hukku 1991.

Methods Location of trial: India.
Number of centres: 1.
Funding: not stated.
Trial ID: not stated.
Participants Inclusion criteria: histologically proven squamous cell carcinoma, T3‐4, N0‐3, with primary tumours in oral cavity, oropharynx, larynx and nasopharynx.
Exclusion criteria: chronic medical problems and distant metastases.
Recruitment period: January 1980 to August 1983.
OC: 7/110 (6%).
OP: 72/110 (65%).
OC+OP: 79/110 (70%).
Number randomised: 110.
Number analysed: 110.
Interventions Split course radiotherapy versus accelerated radiotherapy
Split course (n = 50): Phase 1: 15 fractions of 2.3 Gy over 3 weeks to primary tumour and bilateral neck. 2‐week break. Phase 2: 2.5 Gy per fraction for 10 fractions over 2 weeks to primary tumour and residual lymphatic disease if present or upper neck if lymph nodes not palpable.
Conventional (n = 60): 4 Gy per fraction in 2 opposing fields, 5 fractions per week, total of 11 fractions and 44 Gy. Treatment delivered to primary tumour along with bilateral neck with reduction of neck field after 7 fractions.
Outcomes Primary: locoregional control.
Secondary: overall survival, disease free survival, toxicity.
Duration of follow‐up: 2 years.
Notes Dichotomous data only; unable to calculate HR.
Risk of bias
Bias Authors' judgement Support for judgement
Adequate sequence generation? Unclear risk "Randomisation of patients...". No details of method of sequence generation provided.
Allocation concealment? Unclear risk Insufficient information.
Blinding ‐ Outcome Assessors High risk Not mentioned.
Incomplete outcome data addressed? Low risk All randomised patients included in the outcome analyses.
Free of selective reporting? Low risk Important outcomes of overall survival, disease free survival, locoregional control and adverse events reported.
Free of other bias? Low risk Groups appear similar at baseline. No other apparent bias.