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. |