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U.S. National Institutes of Health
Cancer Diagnosis Program Cancer Imaging Program Cancer Therapy Evaluation Program Developmental Therapeutics Program Radiation Research Program Translational Research Program Biometric Research Branch Office of Cancer Complementary and Alternative Medicine
Last Updated: 04/25/2012


The NCI Best Case Series Program New Protocol: A Retrospective Review of Cases of Cancer Patients Treated with an Alternative Regimen

NCI is committed to finding innovative, promising treatments for people with cancer. A research protocol entitled “NCI Best Case Series Program: A Retrospective Review of Cases of Cancer Patients Treated with an Alternative Regimen” provides a process for independent review of medical records and medical imaging from patients treated with unconventional cancer therapies to determine if NCI-initiated research on a specific intervention is warranted. The program has been in existence since about 1991 and approval of a new protocol allows for more details of the reviews conducted to be made available to the public through scientific publications.

Primary Objectives

  • To verify the pathological diagnosis of cancer
  • To verify objective changes in the tumor measurements during the time period of the alternative intervention
  • To verify the medical history

Secondary Objectives

  • To verify the progression-free survival time of individual patients
  • To verify the overall survival time of individual patients

Eligibility Criteria

  • Pathologically or cytologically confirmed diagnosis of cancer
  • Treatment with an alternative approach exclusively or ≥ 4 weeks after conventional treatment
  • Detectable disease prior to the start of the alternative treatment
  • Adequate documentation in the medical records of conventional and alternative regimens, and dates of interventions
  • Identifiable, objective changes in the malignancy during time of treatment

Program Outcomes

  • Potential recommendation for NCI-initiated research
  • Potential publication of NCI review in a peer-reviewed journal

For more information, contact:
Dr. Oluwadamilola Olaku
Case Review and Intramural Science Program
Office of Cancer Complementary and Alternative Medicine (OCCAM)
6116 Executive Boulevard, Suite 609
Bethesda, MD 20892-8339
Phone: 301-435-7980; Fax: 301-480-0075