Trial · NCT00008385

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

NCT00008385, Phase 3, Completed, ECOG-ACRIN Cancer Research Group; results first posted 2016-05-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Selenium in Preventing Tumor Growth in Patients With Previously Resected Stage I Non-small Cell Lung Cancer. Trials, record NCT00008385. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00008385

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Selenium in Preventing Tumor Growth in Patients With Previously Resected Stage I Non-small Cell Lung Cancer
NCT number: NCT00008385
Status: Completed
Phases: Phase 3
Enrollment: 1,772 participants, actual
Lead sponsor: ECOG-ACRIN Cancer Research Group
Conditions: Lung Cancer
Interventions: placebo, selenium
First posted: 2003-01-27
Last updated: 2023-07-05
Results first posted: 2016-05-04

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Incidence Rate of Second Primary Lung Tumor	Assessed annually for 10 years after randomization	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	5-year Progression-free Survival Rate	Assessed annually for 5 years after randomization	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
Secondary	5-year Overall Survival Rate	Assessed annually for 5 years after randomization	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.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Incidence Rate of Second Primary Lung Tumor	Assessed annually for 10 years after randomization	all randomized patients	cases/100 person years	NUMBER
SECONDARY	5-year Progression-free Survival Rate	Assessed annually for 5 years after randomization	All randomized patients	proportion of participants	NUMBER
SECONDARY	5-year Overall Survival Rate	Assessed annually for 5 years after randomization	All randomized patients	proportion of participants	NUMBER

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Incidence Rate of Second Primary Lung Tumor	Arm I (Placebo)	1.30		cases/100 person years
Incidence Rate of Second Primary Lung Tumor	Arm II (Selenium)	1.62		cases/100 person years
5-year Progression-free Survival Rate	Arm I (Placebo)	0.796	95% Confidence Interval 0.755 to 0.837	proportion of participants
5-year Progression-free Survival Rate	Arm II (Selenium)	0.744	95% Confidence Interval 0.724 to 0.764	proportion of participants
5-year Overall Survival Rate	Arm I (Placebo)	0.799	95% Confidence Interval 0.758 to 0.840	proportion of participants
5-year Overall Survival Rate	Arm II (Selenium)	0.768	95% Confidence Interval 0.737 to 0.799	proportion of participants

Source ClinicalTrials.gov

Participant flow10

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm I (Placebo)	521
Overall Study	STARTED	Arm II (Selenium)	1,040
Overall Study	Treated	Arm I (Placebo)	477
Overall Study	Treated	Arm II (Selenium)	865
Overall Study	Off Treatment Reasons Reported	Arm I (Placebo)	398
Overall Study	Off Treatment Reasons Reported	Arm II (Selenium)	795
Overall Study	COMPLETED	Arm I (Placebo)	134
Overall Study	COMPLETED	Arm II (Selenium)	238
Overall Study	NOT COMPLETED	Arm I (Placebo)	387
Overall Study	NOT COMPLETED	Arm II (Selenium)	802

Source ClinicalTrials.gov

Adverse events56

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Fatigue	General disorders	Arm I (Placebo)	32	477
other	Fatigue	General disorders	Arm II (Selenium)	64	865
other	Nail changes	Skin and subcutaneous tissue disorders	Arm I (Placebo)	34	477
other	Nail changes	Skin and subcutaneous tissue disorders	Arm II (Selenium)	46	865
serious	Neutrophils decreased	Investigations	Arm I (Placebo)	0	477
serious	Neutrophils decreased	Investigations	Arm II (Selenium)	1	865
serious	Cardiac-left ventricular function	Cardiac disorders	Arm I (Placebo)	0	477
serious	Cardiac-left ventricular function	Cardiac disorders	Arm II (Selenium)	1	865
serious	Hypotension	Vascular disorders	Arm I (Placebo)	0	477
serious	Hypotension	Vascular disorders	Arm II (Selenium)	1	865

1 to 10 of 56Source ClinicalTrials.gov

See all 56 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm I (Placebo)
Total, all-cause mortality	Arm II (Selenium)
Total, other adverse events	Arm I (Placebo)	55	477
Total, other adverse events	Arm II (Selenium)	99	865
Total, serious adverse events	Arm I (Placebo)	9	477
Total, serious adverse events	Arm II (Selenium)	13	865

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U10CA023318	ECOG Statistical Office	GRAY, ROBERT J	DANA-FARBER CANCER INST	NATIONAL CANCER INSTITUTE	1985 to 2013

Source NIH RePORTER

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Arm II (Selenium) vs Arm I (Placebo): serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00008385

GET https://conductscience.org/api/trials/v1/NCT00008385/events?page=2

API reference For AI assistants