Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information
Selenium in Preventing Tumor Growth in Patients With Previously Resected Stage I Non-small Cell Lung Cancer
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase III | Prevention | Closed | 18 and over | NCI | ECOG-5597 CAN-NCIC-BR16, CALGB-79803, NCCTG-E5597, SWOG-E5597, NCI-P00-0176, NCT00008385, BR16 |
Special Category: NCI Web site featured trial
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.
Entry 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
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
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
Expected Enrollment
1960A total of 1,960 participants (980 per arm) will be accrued for this study within 4 years.
Outcomes
Primary Outcome(s)Incidence second of primary lung tumors
Toxicity
Incidence of specific cancers, mortality from cancer, and overall survival
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.
Trial Lead Organizations
Eastern Cooperative Oncology Group
 | | | |
| Daniel Karp, MD, Protocol chair | |
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Southwest Oncology Group
| | | ||
| Omer Kucuk, MD, Protocol chair | |
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North Central Cancer Treatment Group
| | | |
| Randolph Marks, MD, Protocol chair | |
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NCIC-Clinical Trials Group
| | | ||
| Michael Johnston, MD, FRCSC, Protocol chair | |
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Cancer and Leukemia Group B
| | | |
| Gerald Clamon, MD, Protocol chair | |
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Southwest Oncology Group
| | | |
| Gord Okawara, MD, Protocol chair | |
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Related Information
| Registry Information | ||
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| Official Title | Phase III Chemoprevention Trial Of Selenium Supplementation In Persons With Resected Stage I Non-Small Cell Lung Cancer | |
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| Trial Start Date | 2000-10-06 | |
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| Trial Completion Date | 2014-11-01 (estimated) | |
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| Registered in ClinicalTrials.gov | NCT00008385 | |
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| Date Submitted to PDQ | 2004-11-02 | |
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| Information Last Verified | 2009-11-20 | |
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| NCI Grant/Contract Number | CA21115 | |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
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