MedTrace Logo

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

NCT00008385 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1772

Last updated 2023-07-05

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

OTHER

placebo

Given orally

DRUG

selenium

Given orally

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • SWOG Cancer Research Network

    collaborator NETWORK

  • North Central Cancer Treatment Group

    collaborator NETWORK

  • NCIC Clinical Trials Group

    collaborator NETWORK

  • Cancer and Leukemia Group B

    collaborator NETWORK

  • ECOG-ACRIN Cancer Research Group

    lead NETWORK

Principal Investigators

  • Daniel D. Karp, MD · M.D. Anderson Cancer Center

  • Omer Kucuk, MD · Barbara Ann Karmanos Cancer Institute

  • Randolph S. Marks, MD · Mayo Clinic

  • Michael R. Johnston, MD, FRCSC · Nova Scotia Cancer Centre

  • Gerald H. Clamon, MD · Holden Comprehensive Cancer Center

  • Gord Okawara, MD · Margaret and Charles Juravinski Cancer Centre

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-12-18
Primary Completion
2011-06-30
Completion
2019-11-30

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00008385 on ClinicalTrials.gov