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

Background-The entry of patients into randomised clinical trials (RCTs) in lung cancer is low. A study was undertaken to assess the reasons why patien ts with non-small cell lung cancer did not enter a trial involving randomis ation to receive or not receive three courses of cisplatin based chemothera py in addition to primary treatment by surgery, radiotherapy, or best suppo rtive care. Methods-The study was carried out in two large London institutions with a s pecial interest in recruiting patients to lung cancer trials. Patients rece ntly diagnosed as having non-small cell lung cancer were prospectively iden tified and followed to see whether they entered the RCT and, if not, to ide ntify the main reasons why. Results-Six hundred and eighty eight patients newly diagnosed with non-smal l cell lung cancer were identified between November 1995 and July 1998; 274 (39.8%) were deemed ineligible for the RCT for clinical reasons, most freq uently their general condition rendering them unfit for chemotherapy. Anoth er 161 (23.4%) were ineligible for logistical reasons-for example, they wer e discharged to centres not participating in the RCT or they were not consi dered for the trial at an appropriate time in their management. Of 253 pote ntially eligible patients, only 63 (24.9% of those eligible) agreed to ente r the RCT and four entered another study. Of those who did not enter, 77 (4 1.4%) declined without stating a reason, 61 (32.8%) did not want chemothera py, and only eight (4.3%) expressed a wish to have chemotherapy. Conclusions-Despite considerable time and effort, the proportion of patient s recruited was small (9.2%). Many seen were ineligible but, of 253 potenti ally eligible patients, 186 (73.5%) refused to enter the RCT.