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. 2011 May;7(3):148-53.
doi: 10.1200/JOP.2010.000106.

Characteristics and outcomes of patients with advanced gastric cancer who declined to participate in a randomized clinical chemotherapy trial

Chiharu Tanai  1 , Takako Eguchi Nakajima, Kengo Nagashima, Ken Kato, Tetsuya Hamaguchi, Yasuhide Yamada, Kei Muro, Kuniaki Shirao, Hideo Kunitoh, Yasuhiro Matsumura, Seiichiro Yamamoto, Yasuhiro Shimada
Affiliations

Characteristics and outcomes of patients with advanced gastric cancer who declined to participate in a randomized clinical chemotherapy trial

Chiharu Tanai et al. J Oncol Pract. 2011 May.

Abstract

Purpose: There is insufficient data to verify whether participation in clinical trials in itself can lead to better clinical outcomes. We have analyzed the characteristics and outcomes of patients who declined to participate in a randomized trial in comparison with those who participated in the trial.

Patients and methods: A randomized trial for naive advanced gastric cancer was offered to 286 patients. The trial investigated the superiority of irinotecan plus cisplatin and the noninferiority of S-1 compared with continuous fluorouracil infusion. We retrospectively reviewed the characteristics and outcomes for both participants and nonparticipants in this trial.

Results: Of the 286 patients, 98 (34%) declined to participate in the trial. The rate of declining was significantly higher among younger patients (P = .003), and it varied significantly between attending physicians (range, 23% to 58%; P = .004). There were no other significant correlations between rate of declining and patient characteristics. No significant differences were observed in the clinical outcomes between the participants and nonparticipants, for whom the median survival times were 367 versus 347 days, respectively. The hazard ratio for overall survival, adjusted for other confounding variables, was 1.21 (95% CI, 0.91 to 1.60). No interaction was observed between participation and the various regimens.

Conclusion: There was no difference in clinical outcomes between participants and nonparticipants. However, the patient's age and the doctor-patient relationship may have an effect on patient accrual to randomized trials.

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Figures

Figure 1.
Figure 1.
Overall survival of nonparticipants in randomized trials compared with that of participants. No significant difference were observed.
Figure A1.
Figure A1.
Overall survival of patients who were treated with fluorouracil.
Figure A2.
Figure A2.
Overall survival of patients who were treated with irinotecan plus cisplatin.
Figure A3.
Figure A3.
Overall survival of patients who were treated with S-1.
See this image and copyright information in PMC

Comment in

  • J Oncol Pract. 7(3):153.

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References

    1. Lara PN, Jr, Higdon R, Lim N, et al. Prospective evaluation of cancer clinical trial accrual patterns: Identifying potential barriers to enrolment. J Clin Oncol. 2001;19:1728–1733. - PubMed
    1. Corrie P, Shaw J, Harris R. Rate limiting factors in recruitment of patients to clinical trials in cancer research: Descriptive study. BMJ. 2003;327:320–321. - PMC - PubMed
    1. Go RS, Frisby KA, Lee JA, et al. Clinical trial accrual among new cancer patients at a community-based cancer center. Cancer. 2006;106:426–433. - PubMed
    1. Nott L, Yeend S, Pirc L, et al. Successfully improving access and accrual to oncology clinical trials. Cancer. 2007;109:1451–1453. - PubMed
    1. Umutyan A, Chiechi C, Beckett LA, et al. Overcoming barriers to cancer clinical trial accrual. Cancer. 2008;112:212–219. - PubMed