Listed below are clinical trials related to cancer prevention. If you are interested in learning more about a trial, access the Web site address or call the phone number provided for additional information.
Prevention
Lung
Phase II Randomized Pilot Chemoprevention Study of Celecoxib in Former Heavy Smokers At High Risk of Primary or Second Primary Lung Cancer (sponsored by the Jonsson Comprehensive Cancer Center and the NCI)
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Phase I Study of Inositol for the Prevention of Lung Cancer in Patients With Bronchial Epithelial Dysplasia Who Are Current or Former Smokers (sponsored by the British Columbia Cancer Agency and the NCI)
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Phase II Study of Zileuton for the Prevention of Lung Cancer in Patients With Bronchial Dysplasia (sponsored by the Barbara Ann Karmanos Cancer Institute and the NCI)
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Breast
The STAR (Study of Tamoxifen and Raloxifene) trial, one of the largest breast cancer prevention studies ever, is recruiting volunteers at more than 500 centers across the US, Puerto Rico, and Canada. The trial, (sponsored by the National Surgical Adjuvant Breast and Bowel Project [NSABP] and the NCI), will include 22,000 postmenopausal women at increased risk of breast cancer to determine whether the osteoporosis prevention drug raloxifene (Evista®) is as effective in reducing the chance of developing breast cancer as tamoxifen (Nolvadex®). For more information about STAR call the NCI at 1-800-4-CANCER (1900-422-6237) or the Canadian Cancer Society's Cancer Information Service at 1-888-939-3333.
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IBIS-II (International Breast Cancer Intervention Study) is an international, multicenter study of anastrozole versus placebo in 6,000 postmenopausal women at increased risk of breast cancer (a separate part of the study will evaluate anastrozole versus tamoxifen in postmenopausal women with ductal carcinoma in situ).
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PREVENT: Soy for Premenopausal Women at High Risk for Breast Cancer. This study examines if the consumption of dietary soy for 6 months reduces breast cancer risk.
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Phase II Chemoprevention Study of Celecoxib in Premenopausal Women at High Risk For Estrogen Receptor-Negative Breast Cancer (sponsored by the University of Kansas and the NCI)
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Randomized Chemoprevention Study of Bexarotene in Women at High Genetic Risk for Breast Cancer (sponsored by the Baylor College of Medicine and the NCI)
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Pilot Randomized Study of Raloxifene and Goserelin Versus No Medical Intervention in Women at High Genetic Risk for Developing Breast Cancer (sponsored by the National Cancer Research Institute)
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Phase II Chemoprevention Study of Celecoxib in Premenopausal Women at High Risk For Estrogen Receptor-Negative Breast Cancer
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Phase II Randomized Study of Polyphenon E (Green Tea Extract) and Low-Dose Aspirin in Women at High Risk For Developing Breast Cancer
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Randomized Study of Exemestane for the Reduction of Breast Density in Postmenopausal Women at Increased Risk for Breast Cancer
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Prostate
SELECT (Selenium and Vitamin E Cancer Prevention Trial) is the largest-ever prostate cancer prevention trial. SELECT is coordinated by the Southwest Oncology Group (SWOG) and is sponsored by the National Cancer Institute (NCI). Previous studies suggest that selenium and vitamin E (alone or in combination) may reduce the risk of developing prostate cancer by 60% and 30%, respectively, but only a large clinical trial such as SELECT can confirm those initial findings. SELECT began enrolling patients in August 2001 and hopes to enroll 32,400 men over a five-year period. The study is open to men 55 and older. African-American men, 50 and over, are eligible to enroll because prostate cancer strikes African-American men earlier and more often than Caucasian men. There are 435 SELECT sites throughout the United States, Puerto Rico, and Canada. For more information about SELECT, call the NCI at 1-800-4-CANCER or the Canadian Cancer Society's Cancer Information Service at 1-888-939-3333.
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Phase I Study of Lycopene for the Chemoprevention of Prostate Cancer (sponsored by the University of Illinois and the NCI)
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Phase IIB Randomized Chemoprevention Study of Eflornithine (DFMO) in Patients at High Genetic Risk For Prostate Cancer
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Phase II Randomized Study of Dietary Soy in Patients With Elevated PSA Levels (sponsored by the Cancer and Leukemia Group B [CALGB] and the NCI)
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Phase II Randomized Study of Vitamin E, Selenium, and Soy Protein Isolate in Patients With High-Grade Prostatic Intraepithelial Neoplasia
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Phase II Randomized Prevention Study of Fat- and/or Flaxseed-Modified Diets in Patients With Newly Diagnosed Prostate Cancer
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Phase II Randomized Study of the Effects of a Low Fat, High Fiber Diet on Serum Factors in Patients With Prostate Cancer
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Randomized Study of Isoflavones in Reducing Risk Factors in Patients With Stage I or II Prostate Cancer
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Gastrointestinal
Phase II Randomized Study of Celecoxib With or Without Eflornithine For the Prevention of Colorectal Cancer in Participants With Familial Adenomatous Polyposis of the Colorectum (sponsored by the MD Anderson Cancer Center and the NCI)
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Phase II Randomized Chemoprevention Study of Celecoxib in Patients With Premalignant Rectal Polyps or Prior Sporadic Colorectal Neoplasia
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Phase I Study of Curcumin for the Chemoprevention of Colon Cancer (sponsored by the University of Michigan Comprehensive Cancer Center and the NCI)
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Phase II/III Randomized Study of Exisulind as Chemoprevention of Duodenal Polyps in Patients With Familial Adenomatous Polyposis
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Phase II Randomized Study of Sulindac Versus Aspirin Versus Ursodiol for the Prevention of Colorectal Cancer in Patients With Aberrant Crypt Foci and a History of Colorectal Carcinoma or Adenoma
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Phase II Randomized Chemoprevention Study of Celecoxib in Patients With Barrett's Esophagus (sponsored by the Sidney Kimmel Cancer Center and the NCI)
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Gynecologic
Randomized Study of Fenretinide as Chemoprevention in Patients at Increased Risk for Ovarian Cancer (sponsored by the Gynecologic Oncology Group [GOG] and the NCI)
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Phase II Randomized Study of Medroxyprogesterone Versus Ethinyl Estradiol and Norgestrel For the Prevention of Endometrial Carcinogenesis in Women With a Known Hereditary Non-Polyposis Colon Cancer-Associated Gene Mutation
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Phase II Randomized Chemoprevention Study of Topical Imiquimod Preceding Local Ablative or Excisional Therapy in Patients With Recurrent or High-Grade Cervical Intraepithelial Neoplasia
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Phase II Randomized Study of SGN-00101 in Patients With Grade II or III Cervical
Intraepithelial Neoplasia
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Skin
Phase II Randomized Study of Celecoxib for Chemoprevention of Basal Cell Carcinoma in Patients With Basal Cell Nevus Syndrome
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Phase II Randomized Study of Celecoxib as a Chemopreventive Agent Inhibiting UV-Induced Erythema and Biomarkers of Cutaneous Carcinogenesis Participants With FitzpatrickType I-IV Skin (sponsored by the Herbert J. Irving Cancer Center and the NCI)
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Phase II/III Randomized Chemoprevention Study of Celecoxib in Patients With Actinic Keratoses
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Hematologic
Phase II Pilot Study of Celecoxib as Chemoprevention of Head and Neck Squamous Cell Cancer in Patients With Oral Leukoplakia and/or Dysplasia
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Phase II Randomized Chemoprevention Study of Dehydroepiandrosterone (DHEA) Versus Clarithromycin in Patients With Monoclonal Gammopathy of Undetermined or Borderline Significance (sponsored by the Mayo Clinic Cancer Center and the NCI)
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Bladder
Phase IIB/III Randomized Chemoprevention Study of Celecoxib in Patients With Superficial Transitional Cell Carcinoma of the Bladder at High Risk for Recurrence
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Oral
Phase I/II Study of Oral and Intramucosal Ad5CMV-p53 Gene in Patients With Diffuse Premalignant Carcinoma of the Oral Cavity or Oral Pharynx
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Screening/Detection
Lung
NLST (National Lung Screening Trial) is sponsored by the NCI and is enrolling men and women at risk for lung cancer until September 2004. NLST will compare two ways of detecting lung cancer: spiral computed tomography (CT) and standard chest X-ray. This study will aim to show if either test is better at reducing deaths from this disease. The trial also will examine the risks and benefits of spiral CT scans compared to chest X-rays. NLST will enroll 50,000 current or former smokers and take place at 30 study sites throughout the US.
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Randomized Screening Study of Low-Dose Helical Computed Tomography Versus Radiography of the Chest in Participants at High Risk for Lung Cancer
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Screening and Diagnostic Study of Computerized Tomography in Women at High Risk for Lung Cancer
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Breast
Pilot Screening Study of Breast Imaging Outcome Measures in Women At High Genetic Risk of Breast Cancer
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Screening Study of Breast Imaging Outcome Measures and Phase of Menstrual Cycle in Women At High Genetic Risk of Breast Cancer
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Colon
Diagnostic and Screening Comparison Study of Air Contrast Barium Enema, Computed Tomographic Colonography (Virtual Colonoscopy), and Colonoscopy For the Detection of Colonic Lesions in Patients With Factors Related to Colon Cancer
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Gastrointestinal
Randomized Screening Study of Fecal Occult Blood Testing and Multitarget DNA-Based Assay Panel Testing Followed By Colonoscopy in the Detection of Colorectal Cancer
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Gynecologic
Study of Clinical, Genetic, Behavioral, Laboratory, and Epidemiologic Characteristics of Individuals and Families at High Risk of Breast or Ovarian Cancer
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National Ovarian Cancer Early Detection Program: Screening and Genetic Study is sponsored by the NCI and seeks to identify women at high risk of developing ovarian cancer as well as to identify and develop very sensitive and specific tumor markers for the detection of early stage disease. Six thousand women will be entered into the study. For more information, call the NCI at 1-800-4-CANCER.
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Randomized Screening Study of CA 125 and Ultrasound in the Detection of Ovarian Cancer in Postmenopausal Women
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Screening Study for Ovarian Cancer in Women Who are at High Genetic Risk for Developing Ovarian Cancer
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Prospective Screening Study of Risk-Reducing Salpingo-oophorectomy and Longitudinal CA 125 Screening in Participants at Increased Genetic Risk of Ovarian Cancer (sponsored by the GOG and the NCI)
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Study of Primary Screening Strategies For the Detection of Cervical Neoplasia
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Skin
Study of Clinical, Laboratory, and Epidemiologic Characteristics of Individuals and Families at High Risk for Melanoma
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Screening Study of Cancer Risk in Participants Who are Heterozygous Carriers of Xeroderma Pigmentosum Disease Gene Mutations Versus Non-Carrier Blood Relatives or Spouses
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Hematologic
Prospective Study of Clinical, Laboratory, Genetic, and Epidemiological Characterization of Individuals and Families at High Risk for Hematological Cancer
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