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

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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>OBJECTIVES:\n<ul>\n<li>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.</li>\n<li>Evaluate the qualitative and quantitative toxicity of selenium in these patients.</li>\n<li>Compare the incidence of specific cancers, mortality from cancer, and overall survival of participants treated with selenium vs those treated with placebo.</li>\n</ul>\n</p><p> 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.\n<ul>\n<li>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.</li>\n<li>Arm II: Participants receive an oral yeast placebo as in arm I. Participants are followed annually.</li>\n</ul>\n</p><p> PROJECTED ACCRUAL: A total of 1,960 participants (980 per arm) will be accrued for this study within 4 years.</p>\n', created = 1283570180, expire = 1283656580, headers = '', serialized = 0 WHERE cid = '1:1832876247121f8f901c956c4c5d1d51' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>DISEASE CHARACTERISTICS:\n<ul>\n<li>Histologically confirmed, completely resected stage IA (pT1, N0) or IB (pT2, N0) non-small lung cancer (except carcinoid)*\n<ul>\n<li>Completion of treatment for stage I lung cancer within the past 6 to 36 months and currently disease free</li>\n<li>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</li>\n</ul>\n</li>\n<li>No evidence of new or recurrent lung cancer on chest x-ray within the past 8 weeks</li>\n<li>No synchronous lung or non-lung lesions or metastasis, even if resectable</li>\n<li>No history of more than one primary lung cancer at any time</li>\n</ul>\n</p><p> PATIENT CHARACTERISTICS: Age:\n<ul>\n<li>18 and over</li>\n</ul>\n</p><p> Performance status:\n<ul>\n<li>ECOG 0-1</li>\n</ul>\n</p><p> Life expectancy:\n<ul>\n<li>Not specified</li>\n</ul>\n</p><p> Hematopoietic:\n<ul>\n<li>Not specified</li>\n</ul>\n</p><p> Hepatic:\n<ul>\n<li>Bilirubin no greater than upper limit of normal (ULN)</li>\n<li>SGOT or SGPT no greater than ULN</li>\n</ul>\n</p><p> Renal:\n<ul>\n<li>Not specified</li>\n</ul>\n</p><p> Other:\n<ul>\n<li>No concurrent or other prior cancer within the past 5 years except localized non-melanoma skin cancer</li>\n</ul>\n</p><p> PRIOR CONCURRENT THERAPY: Biologic therapy:\n<ul>\n<li>Not specified</li>\n</ul>\n</p><p> Chemotherapy:\n<ul>\n<li>No prior or concurrent chemotherapy for recurrent lung cancer</li>\n</ul>\n</p><p> Endocrine therapy:\n<ul>\n<li>Not specified</li>\n</ul>\n</p><p> Radiotherapy:\n<ul>\n<li>No prior or concurrent radiotherapy for recurrent lung cancer</li>\n</ul>\n</p><p> Surgery:\n<ul>\n<li>See Disease Characteristics</li>\n<li>No concurrent surgery</li>\n</ul>\n</p><p> Other:\n<ul>\n<li>Prior mineral, herbal, phytochemical, or vitamin supplementation allowed</li>\n<li>No concurrent supplement(s) containing more than 50 micrograms of selenium</li>\n<li>Concurrent non-selenium containing mineral, herbal, phytochemical, or vitamin supplementation allowed if schedule and supplementation prior to study remains unchanged</li>\n</ul>\n</p>', created = 1283570180, expire = 1283656580, headers = '', serialized = 0 WHERE cid = '1:cef54ee2117fcd89b8cde6e1757dbf0c' in /persistent/html/includes/cache.inc on line 109.
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Trial phase: 
Phase III
Recruitment status: 
Recruiting

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.

Background information
Trial ID: 
NCT00008385
Other unique IDs: 
CDR0000068402
ECOG-5597
CAN-NCIC-BR16
CALGB-79803
NCCTG-E5597
SWOG-E5597
NCI-P00-0176
Official title: 

Phase III Chemoprevention Trial Of Selenium Supplementation In Persons With Resected Stage I Non-Small Cell Lung Cancer

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.

Number to be enrolled: 
1960 patients
Clinical information
Age groups: 
Adult
Senior
Gender: 
Both
Eligibility 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

Study design: 
Randomized
Prevention
Placebo Control
Double-Blind
Interventions: 
Placebo
selenium
Study arms: 
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.
Placebo Comparator: Participants receive an oral yeast placebo as in arm I.
Conditions treated: 
Lung Cancer
Outcome measurements: 

Toxicity [ Designated as safety issue: Yes ]

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

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

Funding
Funding types: 
NIH
OTHER
NETWORK
Sponsor: 
National Cancer Institute (NCI)
Southwest Oncology Group
Eastern Cooperative Oncology Group
North Central Cancer Treatment Group
National Cancer Institute of Canada
Cancer and Leukemia Group B
Dates
Date the data was first received: 
Sat, 2001-01-06
Trial start date: 
Sun, 2000-10-01
Trial completion date: 
Wed, 1969-12-31
Trial last updated: 
Wed, 2009-05-20