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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,772

participants targeted

Target at P75+ for phase_3 lung-cancer

Timeline

Completed

Started Dec 2000

Longer than P75 for phase_3 lung-cancer

Geographic Reach

2 countries

532 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

18.9 years study duration

Study Start

First participant enrolled

December 18, 2000

Completed

19 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2001

Completed

2.1 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed

8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed

4.9 years until next milestone

Results Posted

Study results publicly available

May 4, 2016

Completed

3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed

Last Updated

July 5, 2023

Status Verified

June 1, 2023

Enrollment Period

10.5 years

First QC Date

January 6, 2001

Results QC Date

February 2, 2016

Last Update Submit

June 20, 2023

Conditions

Lung Cancer

Keywords

stage I non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

Incidence Rate of Second Primary Lung Tumor
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.
Assessed annually for 10 years after randomization

Secondary Outcomes (2)

5-year Progression-free Survival Rate
Assessed annually for 5 years after randomization
5-year Overall Survival Rate
Assessed annually for 5 years after randomization

Study Arms (2)

Arm I

PLACEBO COMPARATOR

Participants receive an oral yeast placebo as in arm II.

Other: placebo

Arm II

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.

Drug: selenium

Interventions

placeboOTHER

Given orally

Arm I

seleniumDRUG

Given orally

Also known as: L-selenomethionine

Arm II

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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
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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

ECOG-ACRIN Cancer Research Grouplead
National Cancer Institute (NCI)collaborator
SWOG Cancer Research Networkcollaborator
North Central Cancer Treatment Groupcollaborator
NCIC Clinical Trials Groupcollaborator
Cancer and Leukemia Group Bcollaborator

Study Sites (532)

MBCCOP - Gulf Coast

Mobile, Alabama, 36604, United States

Location

Providence Cancer Center at Providence Hospital

Mobile, Alabama, 36608, United States

Location

Arizona Oncology Services Foundation

Phoenix, Arizona, 85013, United States

Location

Virginia G. Piper Cancer Center at Scottsdale Healthcare - Osborn

Scottsdale, Arizona, 85251, United States

Location

Mayo Clinic Scottsdale

Scottsdale, Arizona, 85259-5499, United States

Location

Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea

Scottsdale, Arizona, 85260, United States

Location

Highlands Oncology Group - Springdale

Bentonville, Arkansas, 72712, United States

Location

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

East Bay Radiation Oncology Center

Castro Valley, California, 94546, United States

Location

Eden Medical Center

Castro Valley, California, 94546, United States

Location

North Bay Cancer Center

Fairfield, California, 94533, United States

Location

Rebecca and John Moores UCSD Cancer Center

La Jolla, California, 92093-0658, United States

Location

Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Contra Costa Regional Medical Center

Martinez, California, 94553-3156, United States

Location

Tibotec Therapeutics - Division of Ortho Biotech Products, LP

Marysville, California, 95901, United States

Location

Memorial Medical Center

Modesto, California, 95355, United States

Location

El Camino Hospital Cancer Center

Mountain View, California, 94040, United States

Location

Highland General Hospital

Oakland, California, 94602, United States

Location

Alta Bates Summit Medical Center - Summit Campus