Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00008385
Status:
COMPLETED
Last Update Posted:
2023-07-05
First Post:
2001-01-06
Brief Title:
Selenium in Preventing Tumor Growth in Patients With Previously Resected Stage I Non-small Cell Lung Cancer
Sponsor:
ECOG-ACRIN Cancer Research Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
Phase III Chemoprevention Trial Of Selenium Supplementation In Persons With Resected Stage I Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
OBJECTIVES
Primary Objective
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
Secondary Objectives
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-blinded 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 in a 12 ratio to arm I and arm II
Arm I Participants receive an oral yeast placebo as in arm II
Arm II 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
Participants are followed annually every 12 months for 10 years
PROJECTED ACCRUAL A total of 1960 participants will be accrued for this study within 4 years
Primary Objective
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
Secondary Objectives
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-blinded 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 in a 12 ratio to arm I and arm II
Arm I Participants receive an oral yeast placebo as in arm II
Arm II 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
Participants are followed annually every 12 months for 10 years
PROJECTED ACCRUAL A total of 1960 participants will be accrued for this study within 4 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000068402 | REGISTRY | CTRP Clinical Trial Reporting Program | httpsreporternihgovquickSearchU10CA023318 |
| E5597 | OTHER | None | None |
| U10CA023318 | NIH | None | None |