Bartelink 2002.
| Methods | Location of trial: Europe. Number of centres: 11. Funding: not stated. Trial ID: not stated (EORTC trial). |
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| Participants | Inclusion criteria: locally advanced, inoperable head & neck cancer with primaries in oral cavity, oropharynx, larynx and hypopharynx. T2‐T4 included. Exclusion criteria: not explicit. Recruitment period: not stated. OC: 16/49 (33%). OP: 23/49 (47%). OC+OP: 39/49 (80%). Number randomised: 53. Number analysed: 49. |
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| Interventions |
Hyperfractionated/accelerated/split course radiotherapy plus chemotherapy versus conventional radiotherapy plus chemotherapy Hyperfractionated/accelerated/split (n = 25): 1.6 Gy per fraction, 3 fractions per day on weeks 1, 4 & 7 (total dose 72 Gy) with 10 mg/m2 cisplatin IV administered daily between fractions 1 & 2. Interfraction interval varied between 3 & 4 hours. Conventional (n = 24): 2 Gy per fraction, 5 fractions per week for a total dose of 70 Gy over 7 weeks together with 6 mg/m2 cisplatin IV 30‐60 minutes prior to RT daily. |
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| Outcomes | Primary: toxicity. Secondary: overall survival, locoregional control. Duration of follow‐up: minimum 24 months. |
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| Notes | HR data taken from Kaplan‐Meier graphs (numbers at risk presented). | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Adequate sequence generation? | Unclear risk | "Patients were randomised between" ‐ method of sequence generation not described. |
| Allocation concealment? | Unclear risk | Insufficient information. |
| Blinding ‐ Outcome Assessors | High risk | Not mentioned. |
| Incomplete outcome data addressed? | Unclear risk | 3/28 (11%) patients in Gr A and 1/25 (4%) in Gr B did not receive allocated treatment. In this small trial this may have resulted in differences between groups with regard to prognostic factors and introduced bias. |
| Free of selective reporting? | Low risk | Primary outcomes are acute and late side effects, but also planned and reported treatment compliance, locoregional control and overall survival. |
| Free of other bias? | Unclear risk | There appear to be differences between treatment groups at baseline eg T stage, location of primary tumour and degree of tumour differentiation. No other bias apparent. |