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Randomized discontinuation design: application to cytostatic antineoplastic agents.

Gary L Rosner1, Walter Stadler, Mark J Ratain

  • 1Cancer and Leukemia Group B Statistical Office and Department of Biostatistics, The University of Texas M.D. Anderson Cancer Center, Houston, TX 77030-4009, USA. glr@odin.mdacc.tmc.edu

Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology
|November 15, 2002
PubMed
Summary

This study proposes a randomized discontinuation design for phase II trials of cytostatic anticancer agents. This method effectively distinguishes drug activity from natural slow tumor growth, improving trial efficiency.

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Area of Science:

  • Oncology
  • Clinical Trial Design

Background:

  • Tumor growth rates in patients with renal cell carcinoma can vary significantly.
  • Distinguishing true antiproliferative drug activity from naturally slow-growing tumors is crucial in clinical trials.

Purpose of the Study:

  • To propose a phase II study design for evaluating cytostatic agents.
  • To address the challenge of heterogeneous tumor growth rates in patient populations.

Main Methods:

  • A randomized discontinuation design is proposed.
  • Stage 1: All patients receive the study agent.
  • Stage 2: Patients with stable disease are randomized to continue therapy or placebo.

Main Results:

  • The design enhances homogeneity in the randomized patient group.

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  • It requires fewer patients compared to traditional randomization at entry.
  • It mitigates confounding from heterogeneous tumor growth rates.

    • Conclusions:

    • The randomized discontinuation design is a feasible and effective approach for phase II trials.
    • It accurately determines the activity of cytostatic anticancer agents.