Recruitment of patients with lung cancer into a randomised clinical trial: experience at two centres
S G Spiroa, N H Gowera b, M T Evansb, F M Facchinia, R M Ruddb, on behalf of the Big Lung Trial Steering Committee
a Department of
Thoracic Medicine, University College London Hospitals NHS Trust,
London, UK, b Department of Medical Oncology, St
Bartholomew's and The London NHS Trust, London, UK
Correspondence to: N H Gower, London Lung Cancer Group, CRC and UCL Cancer Trials Centre, RF and UC Medical School, John Astor House, Foley Street, London W1P 8AN, UK email: n.gower{at}ctc.ucl.ac.uk
Received 13 September 1999; Accepted for publication 22 December 1999
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.
METHODSThe 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.
RESULTSSix 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
reasonsfor 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.
CONCLUSIONSDespite
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.
Keywords: lung cancer; chemotherapy; randomised controlled trials; patient recruitment
© 2000 by Thorax
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