Trial Outcomes & Findings for Selenium in Preventing Tumor Growth in Patients With Previously Resected Stage I Non-small Cell Lung Cancer (NCT NCT00008385)
NCT ID: NCT00008385
Last Updated: 2023-07-05
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1772 participants
Primary outcome timeframe
Assessed annually for 10 years after randomization
Results posted on
2023-07-05
Participant Flow
The study was activated on 10/6/2000, accrued its first patient on 12/18/2000, and terminated early on 11/5/2009 due to futility analysis with a total accrual of 1772 patients to step 1. Of the 1772 patients, 1561 were randomized on step 2.
The study had a 4-week run-in period to select patients with good compliance with the protocol therapy, defined as consuming at least 75% of prescribed placebo tablets. These patients were then randomized.
Participant milestones
| Measure |
Arm I (Placebo)
Participants receive an oral yeast placebo as in arm II.
placebo: Given orally
|
Arm II (Selenium)
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.
selenium: Given orally
|
|---|---|---|
|
Overall Study
STARTED
|
521
|
1040
|
|
Overall Study
Treated
|
477
|
865
|
|
Overall Study
Off Treatment Reasons Reported
|
398
|
795
|
|
Overall Study
COMPLETED
|
134
|
238
|
|
Overall Study
NOT COMPLETED
|
387
|
802
|
Reasons for withdrawal
| Measure |
Arm I (Placebo)
Participants receive an oral yeast placebo as in arm II.
placebo: Given orally
|
Arm II (Selenium)
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.
selenium: Given orally
|
|---|---|---|
|
Overall Study
Off treatment reasons not reported
|
79
|
70
|
|
Overall Study
Progressive disease
|
52
|
117
|
|
Overall Study
Adverse Event
|
8
|
20
|
|
Overall Study
Death
|
12
|
18
|
|
Overall Study
Withdrawal by Subject
|
67
|
157
|
|
Overall Study
Start non-protocol therapy
|
3
|
1
|
|
Overall Study
Other complicating disease
|
17
|
30
|
|
Overall Study
Maximum dose reached
|
0
|
2
|
|
Overall Study
Other
|
105
|
212
|
|
Overall Study
Not start protocol therapy
|
44
|
175
|
Baseline Characteristics
Selenium in Preventing Tumor Growth in Patients With Previously Resected Stage I Non-small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Arm I (Placebo)
n=521 Participants
Participants receive an oral yeast placebo as in arm II.
placebo: Given orally
|
Arm II (Selenium)
n=1040 Participants
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.
selenium: Given orally
|
Total
n=1561 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66 Years
n=93 Participants
|
66 Years
n=4 Participants
|
66 Years
n=27 Participants
|
|
Sex: Female, Male
Female
|
271 Participants
n=93 Participants
|
531 Participants
n=4 Participants
|
802 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
250 Participants
n=93 Participants
|
509 Participants
n=4 Participants
|
759 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Assessed annually for 10 years after randomizationPopulation: all randomized patients
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.
Outcome measures
| Measure |
Arm I (Placebo)
n=521 Participants
Participants receive an oral yeast placebo as in arm II.
placebo: Given orally
|
Arm II (Selenium)
n=1040 Participants
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.
selenium: Given orally
|
|---|---|---|
|
Incidence Rate of Second Primary Lung Tumor
|
1.30 cases/100 person years
|
1.62 cases/100 person years
|
SECONDARY outcome
Timeframe: Assessed annually for 5 years after randomizationPopulation: All randomized patients
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
Outcome measures
| Measure |
Arm I (Placebo)
n=521 Participants
Participants receive an oral yeast placebo as in arm II.
placebo: Given orally
|
Arm II (Selenium)
n=1040 Participants
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.
selenium: Given orally
|
|---|---|---|
|
5-year Progression-free Survival Rate
|
0.796 proportion of participants
Interval 0.755 to 0.837
|
0.744 proportion of participants
Interval 0.724 to 0.764
|
SECONDARY outcome
Timeframe: Assessed annually for 5 years after randomizationPopulation: All randomized patients
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.
Outcome measures
| Measure |
Arm I (Placebo)
n=521 Participants
Participants receive an oral yeast placebo as in arm II.
placebo: Given orally
|
Arm II (Selenium)
n=1040 Participants
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.
selenium: Given orally
|
|---|---|---|
|
5-year Overall Survival Rate
|
0.799 proportion of participants
Interval 0.758 to 0.84
|
0.768 proportion of participants
Interval 0.737 to 0.799
|
Adverse Events
Arm I (Placebo)
Serious events: 9 serious events
Other events: 55 other events
Deaths: 0 deaths
Arm II (Selenium)
Serious events: 13 serious events
Other events: 99 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (Placebo)
n=477 participants at risk
Participants receive an oral yeast placebo as in arm II. placebo: Given orally
|
Arm II (Selenium)
n=865 participants at risk
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.
selenium: Given orally
|
|---|---|---|
|
Investigations
Neutrophils decreased
|
0.00%
0/477 • assessed starting month 3 and continuing every 6 months (1 cycle=6 months, 8 cycles in total) for the duration of the study and for 30 days after the end of treatment
|
0.12%
1/865 • assessed starting month 3 and continuing every 6 months (1 cycle=6 months, 8 cycles in total) for the duration of the study and for 30 days after the end of treatment
|
|
Cardiac disorders
Cardiac-left ventricular function
|
0.00%
0/477 • assessed starting month 3 and continuing every 6 months (1 cycle=6 months, 8 cycles in total) for the duration of the study and for 30 days after the end of treatment
|
0.12%
1/865 • assessed starting month 3 and continuing every 6 months (1 cycle=6 months, 8 cycles in total) for the duration of the study and for 30 days after the end of treatment
|
|
Vascular disorders
Hypotension
|
0.00%
0/477 • assessed starting month 3 and continuing every 6 months (1 cycle=6 months, 8 cycles in total) for the duration of the study and for 30 days after the end of treatment
|
0.12%
1/865 • assessed starting month 3 and continuing every 6 months (1 cycle=6 months, 8 cycles in total) for the duration of the study and for 30 days after the end of treatment
|
|
Vascular disorders
Thrombosis/embolism
|
0.00%
0/477 • assessed starting month 3 and continuing every 6 months (1 cycle=6 months, 8 cycles in total) for the duration of the study and for 30 days after the end of treatment
|
0.12%
1/865 • assessed starting month 3 and continuing every 6 months (1 cycle=6 months, 8 cycles in total) for the duration of the study and for 30 days after the end of treatment
|
|
General disorders
Constitutional
|
0.21%
1/477 • assessed starting month 3 and continuing every 6 months (1 cycle=6 months, 8 cycles in total) for the duration of the study and for 30 days after the end of treatment
|
0.00%
0/865 • assessed starting month 3 and continuing every 6 months (1 cycle=6 months, 8 cycles in total) for the duration of the study and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
0.42%
2/477 • assessed starting month 3 and continuing every 6 months (1 cycle=6 months, 8 cycles in total) for the duration of the study and for 30 days after the end of treatment
|
0.12%
1/865 • assessed starting month 3 and continuing every 6 months (1 cycle=6 months, 8 cycles in total) for the duration of the study and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Skin-other
|
0.21%
1/477 • assessed starting month 3 and continuing every 6 months (1 cycle=6 months, 8 cycles in total) for the duration of the study and for 30 days after the end of treatment
|
0.00%
0/865 • assessed starting month 3 and continuing every 6 months (1 cycle=6 months, 8 cycles in total) for the duration of the study and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/477 • assessed starting month 3 and continuing every 6 months (1 cycle=6 months, 8 cycles in total) for the duration of the study and for 30 days after the end of treatment
|
0.12%
1/865 • assessed starting month 3 and continuing every 6 months (1 cycle=6 months, 8 cycles in total) for the duration of the study and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Colitis
|
0.21%
1/477 • assessed starting month 3 and continuing every 6 months (1 cycle=6 months, 8 cycles in total) for the duration of the study and for 30 days after the end of treatment
|
0.00%
0/865 • assessed starting month 3 and continuing every 6 months (1 cycle=6 months, 8 cycles in total) for the duration of the study and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/477 • assessed starting month 3 and continuing every 6 months (1 cycle=6 months, 8 cycles in total) for the duration of the study and for 30 days after the end of treatment
|
0.12%
1/865 • assessed starting month 3 and continuing every 6 months (1 cycle=6 months, 8 cycles in total) for the duration of the study and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/477 • assessed starting month 3 and continuing every 6 months (1 cycle=6 months, 8 cycles in total) for the duration of the study and for 30 days after the end of treatment
|
0.12%
1/865 • assessed starting month 3 and continuing every 6 months (1 cycle=6 months, 8 cycles in total) for the duration of the study and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Stomatitis
|
0.21%
1/477 • assessed starting month 3 and continuing every 6 months (1 cycle=6 months, 8 cycles in total) for the duration of the study and for 30 days after the end of treatment
|
0.00%
0/865 • assessed starting month 3 and continuing every 6 months (1 cycle=6 months, 8 cycles in total) for the duration of the study and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/477 • assessed starting month 3 and continuing every 6 months (1 cycle=6 months, 8 cycles in total) for the duration of the study and for 30 days after the end of treatment
|
0.12%
1/865 • assessed starting month 3 and continuing every 6 months (1 cycle=6 months, 8 cycles in total) for the duration of the study and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
0.00%
0/477 • assessed starting month 3 and continuing every 6 months (1 cycle=6 months, 8 cycles in total) for the duration of the study and for 30 days after the end of treatment
|
0.23%
2/865 • assessed starting month 3 and continuing every 6 months (1 cycle=6 months, 8 cycles in total) for the duration of the study and for 30 days after the end of treatment
|
|
Infections and infestations
Infection-other
|
0.21%
1/477 • assessed starting month 3 and continuing every 6 months (1 cycle=6 months, 8 cycles in total) for the duration of the study and for 30 days after the end of treatment
|
0.00%
0/865 • assessed starting month 3 and continuing every 6 months (1 cycle=6 months, 8 cycles in total) for the duration of the study and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.21%
1/477 • assessed starting month 3 and continuing every 6 months (1 cycle=6 months, 8 cycles in total) for the duration of the study and for 30 days after the end of treatment
|
0.00%
0/865 • assessed starting month 3 and continuing every 6 months (1 cycle=6 months, 8 cycles in total) for the duration of the study and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/477 • assessed starting month 3 and continuing every 6 months (1 cycle=6 months, 8 cycles in total) for the duration of the study and for 30 days after the end of treatment
|
0.23%
2/865 • assessed starting month 3 and continuing every 6 months (1 cycle=6 months, 8 cycles in total) for the duration of the study and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/477 • assessed starting month 3 and continuing every 6 months (1 cycle=6 months, 8 cycles in total) for the duration of the study and for 30 days after the end of treatment
|
0.12%
1/865 • assessed starting month 3 and continuing every 6 months (1 cycle=6 months, 8 cycles in total) for the duration of the study and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/477 • assessed starting month 3 and continuing every 6 months (1 cycle=6 months, 8 cycles in total) for the duration of the study and for 30 days after the end of treatment
|
0.12%
1/865 • assessed starting month 3 and continuing every 6 months (1 cycle=6 months, 8 cycles in total) for the duration of the study and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Joint, muscle, bone-other
|
0.00%
0/477 • assessed starting month 3 and continuing every 6 months (1 cycle=6 months, 8 cycles in total) for the duration of the study and for 30 days after the end of treatment
|
0.12%
1/865 • assessed starting month 3 and continuing every 6 months (1 cycle=6 months, 8 cycles in total) for the duration of the study and for 30 days after the end of treatment
|
|
Psychiatric disorders
Depression
|
0.00%
0/477 • assessed starting month 3 and continuing every 6 months (1 cycle=6 months, 8 cycles in total) for the duration of the study and for 30 days after the end of treatment
|
0.12%
1/865 • assessed starting month 3 and continuing every 6 months (1 cycle=6 months, 8 cycles in total) for the duration of the study and for 30 days after the end of treatment
|
|
Nervous system disorders
Syncope
|
0.00%
0/477 • assessed starting month 3 and continuing every 6 months (1 cycle=6 months, 8 cycles in total) for the duration of the study and for 30 days after the end of treatment
|
0.12%
1/865 • assessed starting month 3 and continuing every 6 months (1 cycle=6 months, 8 cycles in total) for the duration of the study and for 30 days after the end of treatment
|
|
General disorders
Chest pain
|
0.00%
0/477 • assessed starting month 3 and continuing every 6 months (1 cycle=6 months, 8 cycles in total) for the duration of the study and for 30 days after the end of treatment
|
0.12%
1/865 • assessed starting month 3 and continuing every 6 months (1 cycle=6 months, 8 cycles in total) for the duration of the study and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.21%
1/477 • assessed starting month 3 and continuing every 6 months (1 cycle=6 months, 8 cycles in total) for the duration of the study and for 30 days after the end of treatment
|
0.12%
1/865 • assessed starting month 3 and continuing every 6 months (1 cycle=6 months, 8 cycles in total) for the duration of the study and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary-other
|
0.00%
0/477 • assessed starting month 3 and continuing every 6 months (1 cycle=6 months, 8 cycles in total) for the duration of the study and for 30 days after the end of treatment
|
0.12%
1/865 • assessed starting month 3 and continuing every 6 months (1 cycle=6 months, 8 cycles in total) for the duration of the study and for 30 days after the end of treatment
|
|
Investigations
Creatinine increased
|
0.00%
0/477 • assessed starting month 3 and continuing every 6 months (1 cycle=6 months, 8 cycles in total) for the duration of the study and for 30 days after the end of treatment
|
0.12%
1/865 • assessed starting month 3 and continuing every 6 months (1 cycle=6 months, 8 cycles in total) for the duration of the study and for 30 days after the end of treatment
|
Other adverse events
| Measure |
Arm I (Placebo)
n=477 participants at risk
Participants receive an oral yeast placebo as in arm II. placebo: Given orally
|
Arm II (Selenium)
n=865 participants at risk
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.
selenium: Given orally
|
|---|---|---|
|
General disorders
Fatigue
|
6.7%
32/477 • assessed starting month 3 and continuing every 6 months (1 cycle=6 months, 8 cycles in total) for the duration of the study and for 30 days after the end of treatment
|
7.4%
64/865 • assessed starting month 3 and continuing every 6 months (1 cycle=6 months, 8 cycles in total) for the duration of the study and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
7.1%
34/477 • assessed starting month 3 and continuing every 6 months (1 cycle=6 months, 8 cycles in total) for the duration of the study and for 30 days after the end of treatment
|
5.3%
46/865 • assessed starting month 3 and continuing every 6 months (1 cycle=6 months, 8 cycles in total) for the duration of the study and for 30 days after the end of treatment
|
Additional Information
Study statistician
ECOG-ACRIN Statistical Office
Phone: 617-632-3012
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60