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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Southwest Oncology Group
North Central Cancer Treatment Group
NCIC Clinical Trials Group
Cancer and Leukemia Group B
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00008385
First received: January 6, 2001
Last updated: November 21, 2009
Last verified: November 2009
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Phase III Chemoprevention Trial Of Selenium Supplementation In Persons With Resected Stage I Non-Small Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

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
Experimental: 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.
 Dietary Supplement: selenium
Given orally
Placebo Comparator: Arm II
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
NCIC Clinical Trials Group
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

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
Featured trial article  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Robert L. Comis, ECOG Group Chair's Office
ClinicalTrials.gov Identifier: NCT00008385     History of Changes
Other 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: November 21, 2009
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
 Selenium
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on May 16, 2013