Clinical Research Protocols
Clinical Research Protocols for Cancer Prevention
Compiled by Margaret Gross-King, RN, MS, OCN, and
Gail L. Shaw, MD, FACP
H. Lee Moffitt Cancer Center & Research Institute
This list of clinical research protocols relating to cancer prevention
is compiled for your convenience.
Head and Neck Cancer
RTOG-9115 NCI-C91-0002 Chemoprevention Trial With Low-Dose 13-Cis-Retinoic Acid
to Prevent Second Primary Tumors in Head and Neck Cancer Patients (Summary last modified
02/93).
Chairman Waun Ki Hong, University of Texas-MD Anderson Cancer Center, Houston, Tex. Lead
organization: Radiation Therapy Oncology Group. Acceptable age range: 18 to 74.
EST-C-0590 Phase III Double-Blind Randomized Study of Low-Dose 13-CRA on
Prevention of Second Primaries in Patients With Totally Resected Stage I/II Squamous Cell
Carcinoma of the Head and Neck (Summary last modified 10/96).
Chairman Harlan A. Pinto, Stanford University Medical Center, Stanford, Calif. Lead
organization: Eastern Cooperative Oncology Group. Acceptable age range: over 18.
MDA-DM-90096 Phase III Randomized Chemoprevention Study of Long-Term, Low-Dose
Isotretinoin vs Vitamin A in Patients With Premalignant Lesions of the Oral Cavity
(Summary last modified 12/96).
Chairman Scott M. Lippman, University of Texas-MD Anderson Cancer Center, Houston, Tex.
Lead organization: University of Texas-MD Anderson Cancer Center. Acceptable age range: 18
and over.
Colorectal Cancer
CLB-9270 Phase III Randomized Chemoprevention Study of Aspirin in Patients With
Curatively Treated Dukes Stage A/B1/B2/C Colorectal Cancer (Summary last modified 10/95).
Chairman Robert A. Sandler, University of North Carolina, Chapel Hill, NC. Lead
organization: Cancer and Leukemia Group B. Acceptable age range: over 30 and under 75.
UARIZ-A88138 NCI-P92-0008 Phase III Randomized Study of the Effect of Wheat Bran
Fiber on Adenomatous Polyp Recurrence and Rectal Mucosal Proliferation Rates in Patients
With Resected Colorectal Adenoma (Summary last modified 06/96).
Chairman David S. Alberts, Arizona Cancer Center, Tucson, Ariz. Lead organization: Arizona
Cancer Center, Tucson, Ariz. Acceptable age range: 40 to 80.
E-8292 Phase II Randomized, Double-Blind, Placebo-Controlled Study of High-Dose
Folic Acid for the Prevention of Colorectal Cancer in Patients With Resected Adenomatous
Polyps (Summary last modified 10/96).
Chairman Joel Mason, New England Medical Center, Boston, Mass. Lead organization: Eastern
Cooperative Oncology Group. Acceptable age range: 21 and over.
SWOG-9041 Pilot Randomized, Placebo-Controlled Study of Calcium for
Chemoprevention of Colorectal Adenomas and New Primary Carcinomas in Surgically Treated
Patients (Summary last modified 02/95).
Chairman David Z. J. Chu, Beckman Research Institute of the City of Hope, Duarte, Calif.
Lead organization: Southwest Oncology Group. Acceptable age range: any age.
DMS-CPHS-10293, NCI-P95-0063 Randomized,Double-Blind,Placebo-Controlled Study of
Two Different Doses of Aspirin and Folic Acid (1 mg/d) for the Prevention of Recurrent
Neoplastic Polyps of the Large Bowel in Patients With a History of Large Bowel Adenoma
(Summary last modified 07/95).
Chairman John Baron, Norris Cotton Cancer Center, Dartmouth-Hitchcock Medical Center,
Lebanon, NH. Lead organization: Norris Cotton Cancer Center. Acceptable age range: 21 to
80.
Gynecologic Sites
NCCTG-906951 NCI-P91-0010 Phase III Randomized Study of Interferon Alpha Plus
Laser Therapy Ablation vs Ablation Alone in Patients With CIN Grades I-III (Summary last
modified 10/92).
Chairman Michael J. O’Connell, Mayo Clinic, Rochester, Minn. Lead organization: North
Central Cancer Treatment Group. Acceptable age range: no age specified.
Prostate Cancer
SWOG-9217 NCI-P93-0049 Phase III Randomized, Double-Blind, Placebo-Controlled
Study of Finasteride (Proscar) for the Chemoprevention of Prostate Cancer (Closed
12/6/96).
Chairman Ian M. Thompson, Brooke Army Medical Center, Fort Sam Houston, Tex. Lead
organization: Southwest Oncology Group. Acceptable age range: 55 and over.
Lung Cancer
UCHSC-92382 Phase II Study of 13-CRA With or Without VIT-E for the
Chemoprevention of Lung Cancer (Summary last modified 12/96).
Chairman Karen Kelly, University of Colorado Cancer Center, Denver, Colo. Lead
organization: University of Colorado Cancer Center. Acceptable age range: over 18.
E-5593 Early Detection of Second Primary Lung Cancer by Sputum Cytology
Immunostaining in Patients With Curatively Resected Stage I Non-Small Cell Lung Cancer
(Summary last modified 10/95).
Chairman John C. Ruckdeschel, H. Lee Moffitt Cancer Center & Research Institute,
Tampa, Fla. Lead organization: Eastern Cooperative Oncology Group. Acceptable age range:
18 and over.
NCI-92-C-0052C Pilot Study of Neuroendocrine Peptide Levels as Potential
Predictors of Second Lung Cancer After Surgical Resection With Curative Intent in Stage
I/II Non-Small Cell Lung Cancer (Summary last modified 03/96).
Chairman Michael J. Kelly, NCI-Navy Medical Oncology Branch, National Institutes of
Health, Bethesda, Md. Lead organization: National Cancer Institute. Acceptable age range:
18 and over.
UCHSC-92385 Study to Evaluate the Reversion of Premalignant Markers Following
Smoking Cessation in Patients at High Risk for Developing Lung Cancer (Summary last
modified 06/96).
Chairman Allan Prochazka, University of Colorado Cancer Center, Denver, Colo. Lead
organization: University of Colorado Cancer Center. Acceptable age range: over 30.
MDA-ID-91025 Phase III Double-Blind, Randomized Trial of 13-CRA vs Placebo to
Prevent Second Primary Tumors in Patients With Totally Resected Stage I Non-Small Cell
Lung Cancer (Summary last modified 07/96).
Chairman Scott M. Lippman, University of Texas-MD Anderson Cancer Center, Houston, Tex.
Lead organization: University of Texas-MD Anderson Cancer Center. Acceptable age range:
over 18.
Breast Cancer
UKCCCR-IBIS EU-94041 Randomized, Double-Blind, Placebo-Controlled Study of
Tamoxifen for the Prevention of Breast Cancer in High-Risk Women: International Breast
Cancer Intervention Study (Summary last modified 12/96).
Chairman Jack Cuzick, Imperial Cancer Research Fund, London, England. Lead organization:
United Kingdom Coordinating Committee on Cancer Research. Acceptable age range: 35 to 65.
NCI-94-C-0056J Pilot Chemoprevention Study of Tamoxifen and Fenretinide in
Subjects at High Risk for Developing Invasive Breast Cancer (Summary last modified 10/96).
Chairman Joanne Zujewski, NCI Medicine Branch, Bethesda, Md. Lead organization: National
Cancer Institute. Acceptable age range: 35 and over.
UARIZ-HSC-A93.116 NCI-P94-0060 Randomized Pilot Study to Evaluate the Role of
Dietary Fat Reduction and an Increased Intake of Fruits and Vegetables for Prevention of
Breast Cancer in Postmenopausal Women (Summary last modified 12/96).
Chairman Yei-Mei Peng, University of Arizona Cancer Center, Tucson, Ariz. Lead
organization: University of Arizona Cancer Center. Acceptable age range: 50 to 65.
NSABP-P-1 Randomized, Placebo-Controlled Clinical Trial to Determine the Worth
of Tamoxifen for Preventing Breast Cancer (Summary last modified 02/97).
Chairman Norman Wolmark, Allegheny General Hospital, Pittsburgh, Pa. Lead organization:
National Surgical Adjuvant Breast and Bowel Project. Acceptable age range: 35 and over.
Skin Cancer
NIAMS-91-AR-0161 Use of Isotretinoin for the Prevention of Skin Cancer in
Patients With Xeroderma Pigmentosum or Nevoid Basal Cell Carcinoma Syndrome (Summary last
modified 06/96).
Chairman John J. DiGiovanna, Intramural Research Program, National Institute of Arthritis
and Musculoskeletal and Skin Diseases, National Institutes of Health, Bethesda, Md. Lead
organization: NIAMS. Acceptable age range: over 2.
Multiple Sites
EORTC-08871 Phase III Randomized Comparison of the Influence of Chemoprevention
With Vitamin A and/or N-Acetylcysteine vs No Treatment on Development and Detection of
Second Primary Cancers in Patients Curatively Treated for Laryngeal, Oral Cavity, and
Non-Small Cell Lung Carcinoma (Summary last modified 11/94).
Chairman Guisseppe Giaccone, Academish Ziekenhuis der Vrije Universiteit, Amsterdam, The
Netherlands. Lead organization: European Organization for the Research and Treatment of
Cancer. Acceptable age range: 75 and under.
PLCO-1 A 16-Year Randomized Screening Trial for Prostate, Lung, Colorectal, and
Ovarian Cancer - PLCO Trial (Summary last modified 12/96).
Chairman John K. Gohagan, Early Detection Branch, National Cancer Institute, National
Institutes of Health, Bethesda, Md. Lead organization: National Cancer Institute.
Acceptable age range: 55 to 74.
Legend for Abbreviations:
CLB = Cancer & Leukemia Group B
DMS = Dartmouth-Hitchcock Medical Center
E, EST = Eastern Cooperative Oncology Group
EORTC = European Organization for Research on Treatment of Cancer
MDA = MD Anderson Cancer Center
NCCTG = North Central Cancer Treatment Group
NCI = National Cancer Institute
NIAMS = National Institute of Arthritis and Musculoskeletal and Skin Diseases
NSABP = National Surgical Adjuvant Breast & Bowel Project
PLCO = Prostate, Lung, Colorectal, and Ovarian Cancer Trial
RTOG = Radiation Oncology Group
SWOG = Southwest Oncology Group
UARIZ = University of Arizona
UCHSC = University of Colorado Health Sciences Center
UKCCCR = United Kingdom Coordinating Committee on Cancer Research
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