Recruitment of patients with lung cancer into a randomised clinical trial: experience at two centres

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Abstract
BACKGROUND The entry of patients into randomised clinical trials (RCTs) in lung cancer is low. A study was undertaken to assess the reasons why patients with non-small cell lung cancer did not enter a trial involving randomisation to receive or not receive three courses of cisplatin based chemotherapy in addition to primary treatment by surgery, radiotherapy, or best supportive care. METHODS The study was carried out in two large London institutions with a special interest in recruiting patients to lung cancer trials. Patients recently diagnosed as having non-small cell lung cancer were prospectively identified and followed to see whether they entered the RCT and, if not, to identify the main reasons why. RESULTS Six hundred and eighty eight patients newly diagnosed with non-small cell lung cancer were identified between November 1995 and July 1998; 274 (39.8%) were deemed ineligible for the RCT for clinical reasons, most frequently their general condition rendering them unfit for chemotherapy. Another 161 (23.4%) were ineligible for logistical reasons—for example, they were discharged to centres not participating in the RCT or they were not considered for the trial at an appropriate time in their management. Of 253 potentially eligible patients, only 63 (24.9% of those eligible) agreed to enter the RCT and four entered another study. Of those who did not enter, 77 (41.4%) declined without stating a reason, 61 (32.8%) did not want chemotherapy, and only eight (4.3%) expressed a wish to have chemotherapy. CONCLUSIONS Despite considerable time and effort, the proportion of patients recruited was small (9.2%). Many seen were ineligible but, of 253 potentially eligible patients, 186 (73.5%) refused to enter the RCT.