Treatment of endotracheal or endobronchial obstruction by non-small cell lung cancer: lack of patients in an MRC randomized trial leaves key questions unanswered. Medical Research Council Lung Cancer Working Party.

Symptoms of endotracheal or endobronchial obstruction caused by non-small cell lung cancer (NSCLC) may be relieved with external beam radiotherapy (XRT) or endobronchial treatment. The comparative roles of these two methods need to be established. Patients with predominantly intraluminal obstruction of the trachea, a main bronchus or a lobar bronchus by unresectable NSCLC were randomized to XRT versus the clinician's choice of endobronchial treatment with brachytherapy, laser resection or cryotherapy, according to local availability and practice. Clinicians' assessments included symptoms of obstruction, WHO performance status, lung function tests and adverse effects of treatment. Patients completed a Rotterdam Symptom Checklist at all assessments and a daily diary card to record the severity of major symptoms during the first 4 weeks. To show a difference of 15% in the relief of breathlessness rates at 4 months (from 65% to 80%), 400 patients were required. In spite of our many previously successful lung cancer trials, and initial interest from clinicians in 24 UK centres, who estimated they could randomize 200 patients per year into the present trial, only 75 patients were randomized from seven centres over 3.5 years. Intake to the trial was therefore abandoned in November 1996 although an independent Data Monitoring and Ethics Committee had concluded in April 1996 that the scientific case for the trial was still strong; there were no competing trials; there were no design problems; and much had been done to promote the trial. The main reasons given by centres for the slow intake were: lack of referrals of untreated patients; patients being referred specifically for endobronchial treatment; patients having already received XRT; emergency endobronchial relief of obstruction being necessary; and XRT and endobronchial treatment being considered complementary and not as alternatives. The relative advantages and disadvantages of XRT versus endobronchial treatment remain to be determined. The lack of recruitment to this trial raises the issue of innovative techniques not being given the chance of proving their worth compared with traditional treatments.