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

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Trial Conditions
  • Lung Cancer
What is the purpose of this trial?

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.

Date & Status

Active, not recruiting

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

Eligibility

DISEASE CHARACTERISTICS:

- 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: *SWOG and 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

- No evidence of new or recurrent lung cancer on chest x-ray within the past 8 weeks

- No synchronous lung or non-lung lesions or metastasis, even if resectable

- No history of more than one primary lung cancer at any time

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-1

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Bilirubin no greater than upper limit of normal (ULN)

- SGOT or SGPT no greater than ULN

Renal:

- Not specified

Other:

- No concurrent or other prior cancer within the past 5 years except localized
non-melanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior or concurrent chemotherapy for recurrent lung cancer

Endocrine therapy:

- Not specified

Radiotherapy:

- No prior or concurrent radiotherapy for recurrent lung cancer

Surgery:

- See Disease Characteristics

- No concurrent surgery

Other:

- Prior mineral, herbal, phytochemical, or vitamin supplementation allowed

- No concurrent supplement(s) containing more than 50 micrograms of selenium

- Concurrent non-selenium containing mineral, herbal, phytochemical, or vitamin
supplementation allowed if schedule and supplementation prior to study remains
unchanged

Gender: Both
Steward Physician(s)
  • Daniel D. Karp, MD
  • Omer Kucuk, MD
  • Randolph S. Marks, MD
  • Michael R. Johnston, MD, FRCSC
  • Gerald H. Clamon, MD
  • Gord Okawara, MD
Facilities
  • Norwood Hospital - Active, not recruiting
  • St. Elizabeth's Medical Center - Active, not recruiting
Trial Interventions
Dietary Supplement
  • selenium
Other
  • placebo
Physician Researcher

Investigator Name:

  • Daniel D. Karp, MD
  • Omer Kucuk, MD
  • Randolph S. Marks, MD
  • Michael R. Johnston, MD, FRCSC
  • Gerald H. Clamon, MD
  • Gord Okawara, MD

Other Information

Sponsor: Eastern Cooperative Oncology Group
Phase: Phase 3
Trial ID: NCT00008385
Volunteers:  Not Accepting Healthy Volunteers

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