Results of the Dutch National Study of the Palliative Effect of Irradiation Using Two Different Treatment Schemes for Non–Small-Cell Lung Cancer

Purpose A national multicenter randomized study compared the efficacy of 2 × 8 Gy versus our standard 10 × 3 Gy in patients with inoperable stage IIIA/B (with an Eastern Cooperative Oncology Group score of 3 to 4 and/or substantial weight loss) and stage IV non–small-cell lung cancer. Patients and Methods Between January 1999 and June 2002, 297 patients were eligible and randomized to receive either 10 × 3 Gy or 2 × 8 Gy by external-beam irradiation. The primary end point was a patient-assessed score of treatment effect on seven thoracic symptoms using an adapted Rotterdam Symptom Checklist. Study sample size was determined based on an average total symptom score difference of more than one point over the initial 39 weeks post-treatment. The time course of symptom scores were also evaluated, and other secondary end points were toxicity and survival. Results Both treatment arms were equally effective, as the average total symptom score over the initial 39 weeks did not differ. However, the pattern in time ...