Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been terminated.
(The trial was stopped based on futility analysis results in November 2009.)
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 (Responsible Party):
Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group )
ClinicalTrials.gov Identifier:
NCT00008385
First received: January 6, 2001
Last updated: March 31, 2016
Last verified: March 2016
  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
Other: placebo
Drug: selenium
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
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:


Further study details as provided by Eastern Cooperative Oncology Group:

Primary Outcome Measures:
  • Incidence Rate of Second Primary Lung Tumor [ Time Frame: Assessed annually for 10 years after randomization ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 5-year Progression-free Survival Rate [ Time Frame: Assessed annually for 5 years after randomization ] [ Designated as safety issue: No ]

    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

  • 5-year Overall Survival Rate [ Time Frame: Assessed annually for 5 years after randomization ] [ Designated as safety issue: No ]
    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.


Enrollment: 1772
Study Start Date: October 2000
Estimated Study Completion Date: November 2019
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Arm I
Participants receive an oral yeast placebo as in arm II.
Other: placebo
Given orally
Experimental: 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.
Drug: selenium
Given orally
Other Name: L-selenomethionine

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00008385

  Show 532 Study Locations
Sponsors and Collaborators
ECOG-ACRIN Cancer Research 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

Responsible Party: ECOG-ACRIN Cancer Research Group
ClinicalTrials.gov Identifier: NCT00008385     History of Changes
Other Study ID Numbers: E5597  E5597  U10CA023318  CDR0000068402 
Study First Received: January 6, 2001
Results First Received: February 2, 2016
Last Updated: March 31, 2016
Health Authority: United States: Federal Government
United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Individual participant data may be made available upon request as per the ECOG-ACRIN Data Sharing Policy.

Keywords provided by Eastern Cooperative Oncology Group:
stage I non-small cell lung cancer

Additional relevant 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
Selenium
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Trace Elements
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on September 26, 2016