Selenium in Preventing Tumor Growth in Patients With Previously Resected Stage I Non-Small Cell Lung Cancer

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Selenium in Preventing Tumor Growth in Patients With Previously Resected Stage I Non-Small Cell Lung Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), February 2009
Sponsors and Collaborators: Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Southwest Oncology Group
North Central Cancer Treatment Group
National Cancer Institute of Canada
Cancer and Leukemia Group B

Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00008385

Purpose
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. It is not yet known if selenium is effective in preventing the growth of new tumors in patients with previously resected non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying selenium to see how well it works compared to a placebo in preventing the development of second primary lung tumors in patients who have undergone surgery to remove stage I non-small cell lung cancer.



Condition Intervention Phase
Lung Cancer
Dietary Supplement: selenium
Other: placebo
Phase III




MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Selenium
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control
Official Title: Phase III Chemoprevention Trial Of Selenium Supplementation In Persons With Resected Stage I Non-Small Cell Lung Cancer


Further study details as provided by National Cancer Institute (NCI):


Primary Outcome Measures:
Incidence second of primary lung tumors [ Designated as safety issue: No ]

Toxicity [ Designated as safety issue: Yes ]

Incidence of specific cancers, mortality from cancer, and overall survival [ Designated as safety issue: No ]


Estimated Enrollment: 1960
Study Start Date: October 2000
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Arm I: Experimental
Participants receive oral selenium yeast daily for 6 months. Treatment repeats every 6 months for 8 courses for a total of 4 years in the absence of unacceptable toxicity. Dietary Supplement: selenium
Given orally
Arm II: Placebo Comparator
Participants receive an oral yeast placebo as in arm I. Other: placebo
Given orally


Detailed Description:
OBJECTIVES:

Determine the efficacy of selenium in terms of reducing the incidence of second primary lung tumors in participants with previously resected stage I non-small cell lung cancer.
Evaluate the qualitative and quantitative toxicity of selenium in these patients.
Compare the incidence of specific cancers, mortality from cancer, and overall survival of participants treated with selenium vs those treated with placebo.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Participants are stratified according to smoking status (actively smoking or stopped less than 1 year ago vs stopped at least 1 year ago vs never smoked or no more than 100 cigarettes ever), gender, and stage and previous therapy (stage IA vs stage IB with previous therapy vs. stage IB with no previous therapy). Participants are randomized to one of two arms.

Arm I: Participants receive oral selenium yeast daily for 6 months. Treatment repeats every 6 months for 8 courses for a total of 4 years in the absence of unacceptable toxicity.
Arm II: Participants receive an oral yeast placebo as in arm I. Participants are followed annually.
PROJECTED ACCRUAL: A total of 1,960 participants (980 per arm) will be accrued for this study within 4 years.

Eligibility


Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Criteria
DISEASE CHARACTERISTICS:

Histologically confirmed, completely resected stage IA (pT1, N0) or IB (pT2, N0) non-small lung cancer (except carcinoid)*

Completion of treatment for stage I lung cancer within the past 6 to 36 months and currently disease free
At least one mediastinal lymph node sampled at resection NOTE: *SWOG and CALGB patients must be T1, N0; CALGB patients may be T2, N0 provided disease was completely resected prior to June 1, 2001 and participation in CALGB 9633 was refused if offered
No evidence of new or recurrent lung cancer on chest x-ray within the past 8 weeks
No synchronous lung or non-lung lesions or metastasis, even if resectable
No history of more than one primary lung cancer at any time
PATIENT CHARACTERISTICS:

Age:

18 and over
Performance status:

ECOG 0-1
Life expectancy:

Not specified
Hematopoietic:

Not specified
Hepatic:

Bilirubin no greater than upper limit of normal (ULN)
SGOT or SGPT no greater than ULN
Renal:

Not specified
Other:

No concurrent or other prior cancer within the past 5 years except localized non-melanoma skin cancer
PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified
Chemotherapy:

No prior or concurrent chemotherapy for recurrent lung cancer
Endocrine therapy:

Not specified
Radiotherapy:

No prior or concurrent radiotherapy for recurrent lung cancer
Surgery:

See Disease Characteristics
No concurrent surgery
Other:

Prior mineral, herbal, phytochemical, or vitamin supplementation allowed
No concurrent supplement(s) containing more than 50 micrograms of selenium
Concurrent non-selenium containing mineral, herbal, phytochemical, or vitamin supplementation allowed if schedule and supplementation prior to study remains unchanged
Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00008385

Show 532 Study Locations

Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Southwest Oncology Group
North Central Cancer Treatment Group
National Cancer Institute of Canada
Cancer and Leukemia Group B
Investigators
Study Chair: Daniel D. Karp, MD M.D. Anderson Cancer Center
Study Chair: Omer Kucuk, MD Barbara Ann Karmanos Cancer Institute
Study Chair: Randolph S. Marks, MD Mayo Clinic
Study Chair: Michael R. Johnston, MD, FRCSC Nova Scotia Cancer Centre
Study Chair: Gerald H. Clamon, MD Holden Comprehensive Cancer Center
Study Chair: Gord Okawara, MD Margaret and Charles Juravinski Cancer Centre

More Information


Clinical trial summary from the National Cancer Institute's PDQ® database
Featured trial article

Study ID Numbers: CDR0000068402, ECOG-5597, CAN-NCIC-BR16, CALGB-79803, NCCTG-E5597, SWOG-E5597, NCI-P00-0176
Study First Received: January 6, 2001
Last Updated: February 10, 2009
ClinicalTrials.gov Identifier: NCT00008385 [history]
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage I non-small cell lung cancer



Study placed in the following topic categories:
Thoracic Neoplasms
Selenium
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma



Additional relevant MeSH terms:
Neoplasms by Site
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Histologic Type
Antioxidants
Molecular Mechanisms of Pharmacological Action
Growth Substances
Physiological Effects of Drugs
Trace Elements
Micronutrients
Protective Agents
Pharmacologic Actions



ClinicalTrials.gov processed this record on February 10, 2009


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