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Phase III Chemoprevention Trial of Selenium Supplementation in
Persons With Resected Stage I Non-Small Cell Lung Cance
Patients who have undergone complete resection of a histologically
proven stage 1A (pT1N0) or stage 1B (pT2N0) non-small cell lung
cancer (except carcinoid) who are currently free of disease. To
be pathologic stage N0, at least one mediastinal lymph node must
have been sampled at resection.; NOTE: CALGB and
SWOG patients must be stage T1N0 to be eligible for this study;
CALGB patients who are stage T2N0 are eligible only if they have
undergone complete resection prior to June 1, 2001 and have previously
refused participation in CALGB 9633 if offered.; Eligible patients
are those between 6 months and 36 months from date of surgical
resection. Pathology material from the initial diagnosis must be
available for review if recurrence occurs.; Patients must not have
received or be currently receiving chemotherapy or radiotherapy
for lung cancer. Chest x-ray or Chest CT < 8 weeks prior
to randomization must show no sign of new or recurrent lung cancer.;
Patients must be > 18 years of age.; Patients must have
normal hepatic function (total bilirubin and SGOT (AST) or SGPT
(ALT), defined as less than or equal to the institutional upper
limit of normal. These laboratory values must be obtained within
8 weeks prior to registration.; Patients must have an ECOG performance
status of 0-1.; Patients not taking mineral, herbal, phytochemical,
or vitamin supplements at the time of entry must agree to not begin
taking such supplements (except for the study designated tablet)
during the course of participation. Patients taking any supplement(s)
prior to study entry must agree to one of the following in order
to be eligible: NOTE: Supplements are defined
as any non-food compound taken by mouth or injection which are
intended to provide dietary factors.; Patients who have been regularly
(at least 3 times per week for more than 4 consecutive weeks during
the year prior to consideration for the trial) taking a supplement
containing selenium are not eligible if the supplement contains > 50 µg
selenium.; Patiens who have been regularly (at least 3 times per
week for more than 4 consecutive weeks during the year prior to
consideration for the trial) taking a supplement that contains < 50 µg
selenium are eligible, provided (s)he agrees to continue taking
the same supplement on the same schedule for the entire duration
of study participation.; If the supplement does NOT contain
selenium, the patient must discontinue supplement(s) for at least
two weeks prior to study entry and agree to remain off supplement(s)
for the duration of study participation; OR agree to continue taking
the same supplement(s), on the same schedule for the entire duration
of study participation.; Any supplement(s) containing > 50 µg
of selenium are absolutely disallowed in this study.; No concurrent
cancers or any prior cancer history within the past 5 years except
localized non-melanoma skin cancer.; No synchronous lesions (lung
+ non-lung) or metastasis, even if resectable. No history of greater
than one lung cancer primary at any time.; Patients must be free
of disease.; Patients must have consumed at least 75% of tablets
during 4 week run-in period.
Selenium yeast vs. placebo yeast.
1750
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