CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,772 enrolled
Drug / intervention
selenium +1 moredrug
Likely dose
Not stated in record
Key inclusion· 6
  • Histologically confirmed, completely resected stage IA (pT1, N0) or IB (pT2, N0) non-small cell lung cancer (except carcinoid)
  • Completion of treatment within past 6 to 36 months and currently disease-free
  • At least one mediastinal lymph node sampled at resection
  • Age 18 years and over
Key exclusion· 7
  • Evidence of new or recurrent lung cancer on chest x-ray within 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 past 5 years except localized non-melanoma skin cancer

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00008385
NCT00008385Phase 3Completed

Phase III Chemoprevention Trial Of Selenium Supplementation In Persons With Resected Stage I Non-Small Cell Lung Cancer

ECOG-ACRIN Cancer Research Group·interventional·Posted Jan 27, 2003·Updated Jul 5, 2023

In Brief

A Phase 3 clinical trial evaluating placebo and selenium for Lung Cancer. Completed, enrolled 1,772 participants across 532 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Cancer
CountriesCanada, United States

Timeline

Phase 3CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartDec 18, 2000
Primary CompletionJun 1, 2011
Study CompletionNov 1, 2019
TodayJul 2, 2026
Enrollment to primary: 10.5 yearsPosted 23.4 years ago

Interventions

placeboother

Given orally

seleniumdrug

Given orally