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.
Brief Title
Selenium in Preventing Tumor Growth in Patients With Previously Resected 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 1:2 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 1,960 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 1:2 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 1,960 participants will be accrued for this study within 4 years.
Completion Date
Completion Date Type
Actual
Conditions
Lung Cancer
Eligibility Criteria
RUN-IN PERIOD:
Inclusion Criteria:
* 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: \*Southwest Oncology Group (SWOG) and Cancer and Leukemia Group B (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
* 18 years old and over
* Eastern Cooperative Oncology Group performance status 0-1
* Bilirubin no greater than upper limit of normal (ULN)
* Serum glutamic-oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT) no greater than ULN
* Prior mineral, herbal, phytochemical, or vitamin supplementation allowed
* Concurrent non-selenium containing mineral, herbal, phytochemical, or vitamin supplementation allowed if schedule and supplementation prior to study remains unchanged
Exclusion Criteria:
* Evidence of new or recurrent lung cancer on chest x-ray within the past 8 weeks
* Synchronous lung or non-lung lesions or metastasis, even if resectable
* History of more than one primary lung cancer at any time
* Concurrent or other prior cancer within the past 5 years except localized non-melanoma skin cancer
* Prior or concurrent chemotherapy for recurrent lung cancer
* Prior or concurrent radiotherapy for recurrent lung cancer
* Concurrent surgery
* Concurrent supplement(s) containing more than 50 micrograms of selenium
STUDY PHASE:
* Free of disease
* Consumed at least 75% of tablets during 4-week run-in period
Inclusion Criteria:
* 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: \*Southwest Oncology Group (SWOG) and Cancer and Leukemia Group B (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
* 18 years old and over
* Eastern Cooperative Oncology Group performance status 0-1
* Bilirubin no greater than upper limit of normal (ULN)
* Serum glutamic-oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT) no greater than ULN
* Prior mineral, herbal, phytochemical, or vitamin supplementation allowed
* Concurrent non-selenium containing mineral, herbal, phytochemical, or vitamin supplementation allowed if schedule and supplementation prior to study remains unchanged
Exclusion Criteria:
* Evidence of new or recurrent lung cancer on chest x-ray within the past 8 weeks
* Synchronous lung or non-lung lesions or metastasis, even if resectable
* History of more than one primary lung cancer at any time
* Concurrent or other prior cancer within the past 5 years except localized non-melanoma skin cancer
* Prior or concurrent chemotherapy for recurrent lung cancer
* Prior or concurrent radiotherapy for recurrent lung cancer
* Concurrent surgery
* Concurrent supplement(s) containing more than 50 micrograms of selenium
STUDY PHASE:
* Free of disease
* Consumed at least 75% of tablets during 4-week run-in period
Inclusion Criteria
Inclusion Criteria:
* 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: \*Southwest Oncology Group (SWOG) and Cancer and Leukemia Group B (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
* 18 years old and over
* Eastern Cooperative Oncology Group performance status 0-1
* Bilirubin no greater than upper limit of normal (ULN)
* Serum glutamic-oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT) no greater than ULN
* Prior mineral, herbal, phytochemical, or vitamin supplementation allowed
* Concurrent non-selenium containing mineral, herbal, phytochemical, or vitamin supplementation allowed if schedule and supplementation prior to study remains unchanged
* 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: \*Southwest Oncology Group (SWOG) and Cancer and Leukemia Group B (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
* 18 years old and over
* Eastern Cooperative Oncology Group performance status 0-1
* Bilirubin no greater than upper limit of normal (ULN)
* Serum glutamic-oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT) no greater than ULN
* Prior mineral, herbal, phytochemical, or vitamin supplementation allowed
* Concurrent non-selenium containing mineral, herbal, phytochemical, or vitamin supplementation allowed if schedule and supplementation prior to study remains unchanged
Gender
All
Gender Based
false
Keywords
stage I non-small cell lung cancer
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT00008385
Org Class
Network
Org Full Name
Eastern Cooperative Oncology Group
Org Study Id
E5597
Overall Status
Completed
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Phase III Chemoprevention Trial Of Selenium Supplementation In Persons With Resected Stage I Non-Small Cell Lung Cancer
Primary Outcomes
Outcome Description
Incidence rate of second primary lung tumor was defined as the number of new second primary lung tumors per 100 population at risk in a year.
Outcome Measure
Incidence Rate of Second Primary Lung Tumor
Outcome Time Frame
Assessed annually for 10 years after randomization
Secondary Ids
Secondary Id
E5597
Secondary Id
U10CA023318
Secondary Id
CDR0000068402
Secondary Outcomes
Outcome Description
Progression-Free Survival (PFS) was defined as the time from randomization to second primary lung cancer or recurrence. Cases without events have been censored at the time of last known alive. Kaplan-Meier method was used to estimate 5-year PFS rate.
Accurate determination of whether a cancer occurrence is recurrence or whether it is a second primary is critical. All suspicious lesions identified clinically and/or radiographically were verified histologically. Patients with at least one of the following is considered as having second primary lung cancer.
1. Different histologic type
2. Location in different lobe
3. Location in contralateral lung
4. Occurrence \> 5 years after initial diagnosis
Accurate determination of whether a cancer occurrence is recurrence or whether it is a second primary is critical. All suspicious lesions identified clinically and/or radiographically were verified histologically. Patients with at least one of the following is considered as having second primary lung cancer.
1. Different histologic type
2. Location in different lobe
3. Location in contralateral lung
4. Occurrence \> 5 years after initial diagnosis
Outcome Time Frame
Assessed annually for 5 years after randomization
Outcome Measure
5-year Progression-free Survival Rate
Outcome Description
Overall survival (OS) was defined as the time from randomization to death due to any cause. Cases without death had been censored at the time of last known alive. Kaplan-Meier method was used to estimate 5-year OS rate.
Outcome Time Frame
Assessed annually for 5 years after randomization
Outcome Measure
5-year Overall Survival Rate
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Joseph Sparano
Investigator Email
jsparano@montefiore.org
Investigator Phone
718-405-8404
Categories Mesh Debug
Lung & Chest Cancers --- LUNG NEOPLASMS
Lung & Chest Cancers --- CARCINOMA, NON-SMALL-CELL LUNG
Lung & Chest Cancers --- RESPIRATORY TRACT NEOPLASMS
Lung & Chest Cancers --- THORACIC NEOPLASMS
Cancer --- NEOPLASMS BY SITE
Cancer --- NEOPLASMS
Lung & Chest Cancers --- LUNG DISEASES
COVID-19 --- LUNG DISEASES
Lung --- LUNG DISEASES
Asthma and Other Respiratory Diseases --- RESPIRATORY TRACT DISEASES
Lung & Chest Cancers --- RESPIRATORY TRACT DISEASES
COVID-19 --- RESPIRATORY TRACT DISEASES
Lung --- RESPIRATORY TRACT DISEASES
Lung & Chest Cancers --- CARCINOMA, BRONCHOGENIC
Lung & Chest Cancers --- BRONCHIAL NEOPLASMS
MeSH Terms
LUNG NEOPLASMS
CARCINOMA, NON-SMALL-CELL LUNG
RESPIRATORY TRACT NEOPLASMS
THORACIC NEOPLASMS
NEOPLASMS BY SITE
NEOPLASMS
LUNG DISEASES
RESPIRATORY TRACT DISEASES
CARCINOMA, BRONCHOGENIC
BRONCHIAL NEOPLASMS
COUNTERFEIT DRUGS
SELENIUM
SUBSTANDARD DRUGS
PHARMACEUTICAL PREPARATIONS
CHALCOGENS
ELEMENTS
INORGANIC CHEMICALS
MINERALS