Radiotherapy and cis-diammine dichloroplatinum (II) as a combined treatment modality for inoperable non-small cell lung cancer: a dose finding study.

A dose finding study was carried out to establish the dose of cis-diammine dichloroplatinum (II), cDDP, that can be combined with high dose radiotherapy routinely in patients with inoperable non-small cell lung cancer. The patients were irradiated over a period of 2 weeks, 5 fractions a week, followed by a rest period of 14 days. Thereafter a second course of 2 weeks was given; a total dose of 55 Gy was achieved. The weekly cDDP administration in a 3 hour infusion with pre- and posthydration preceded the first day irradiation. Twenty patients were evaluable for acute toxicity. The dose limiting factor appeared to be severe nausea and vomiting, which was not responsive to anti-emetic therapy at a cDDP level of 35 mg/m2. No renal or significant hematological side effects were observed. Complete response was seen in 10 patients, using X rays and CT scans; this was confirmed by bronchoscopy with biopsies in 9 patients. Partial remission was scored in 7 patients and no change in 4 patients. cDDP as a radiosensitizer will be further studied at a dose level of 30 mg/m2 a week or 6 mg/m2 a day in a prospective, randomized EORTC Phase II study.

RCT Entities:   Population Interventions Outcomes