Combined postoperative radiotherapy and weekly cisplatin infusion for locally advanced squamous cell carcinoma of the head and neck: preliminary report of a randomized trial.

A prospective clinical trial was designed to evaluate efficacy, toxicity, and patient compliance of concomitant postoperative radiotherapy and Cisplatin infusion in patients with Stage III or IV S.C.C. of the head and neck and histological evidence of extra-capsular spread of tumor in lymph node metastase(s). Cisplatin 50 mg IV with forced hydration was given or not every week (i.e., 7 to 9 cycles) concurrently with radiotherapy. Between 1984 and 1988, 83 patients were randomized: 44 were treated by irradiation without chemotherapy (RT group) and 39 by the combined modality (CM group). There was no significant difference between the two groups in terms of patient characteristics, primary sites, tumor differentiation, T.N. stages, or postoperative prognostic factors. All patients completed the planned radiotherapy. There were seven severe toxicities (greater than grade 3) in the RT group. In the CM group, 30 severe toxicities occurred in 16/39 (41%) patients but none was life-threatening. Seven of 39 (18%) patients received less than two-thirds of the scheduled Cisplatin courses because of intolerance, mainly nausea and vomiting. Preliminary results show a better disease-free survival for the CM group (65% at 24 months) than for the RT group (41% at 24 months). This significant difference is largely due to increased loco-regional control in the CM group (79% vs 59%), the actuarial distant metastasis rates in patients controlled above the clavicles not being statistically different in the two groups.

RCT Entities:   Population Interventions Outcomes