Search 
FAQs & How to use this site
Home | About Us | Contact Us
View Protocol Abstract: E5597
Search All Protocols  Search Open Protocols  Search Closed Protocols  Search Published Protocols  View Search Results

The links after "Participants" show which Southwest Oncology Group institutions are eligible to participate in this study.

The orange "Where is This Study Open?" tab at the bottom of the page shows the institutions whose Institutional Review Boards (IRBs) have approved the protocol so that it can be opened at that institution. Clicking on the Institution Name will show the points of contact for information about this study at that institution.

E5597 - Phase III(Closed)

Status Notes: E5597 was permanently closed effective Nov. 5, 2009.

Phase III Chemoprevention Trial of Selenium Supplementation in Persons with Resected Stage I Non-Small Cell Lung Cancer
Treatment: Selenium, Surgery

Disease Committee: Cancer Control, Lung Cancer

Study Coordinator(s): Omer Kucuk, M.D.

Participants: Members, CCOP, Medical Oncologists, Surgeons

Eligibility Criteria: Pts must have undergone complete resection of a histologically proven Stage 1A (pT1N0) or stage 1B (pT2N0) non-small cell lung cancer (except carcinoid) and be currently free of disease. To be pathologic Stage N0, at lease one mediastinal lymph node must have been sampled at resection. Pts must be 6-36 mos from date of surgical resection. Path material from initial diagnosis must be available for review if recurrence occurs. Pts must not have rec'd or currently be rec'g chemo, RT, or biologic agents for lung cancer. Chest x-ray or CT scan < 8 wks prior to registration must show no sign of new or recurrent lung cancer. Pts w/Stage 1A NSCLC must not have recvd any tx other than surgery (as specified in Section 3.12); Pts w/Stage 1B NSCLC are allowed to have received other primary therapy (adjuvant chemo, RT or biologics) in addition to surgery provided criteria of Section 3.12 & 3.13 are met. Pts must be >= 18 yrs. Pts must have normal hepatic function (bili and SGOT or SGPT <= IULN) within 8 wks prior to registration. Pts must have ECOG PS of 0-1. Pts must not be taking mineral, herbal, phytochemical or vitamin supplements at the time of entry and agree to not begin taking such supplements (see Section 3.17). Pts who have been regularly taking > 50 mcg slelenium are eligible, provided they discontinue its use at least 1 month prior to registration. Pts. who have been regularly taking </= 50 mcg selenium are eligible provided they agree to continue taking the same supplement on the same schedule for the entire duration of study participation. Supplements allowed according to guidelines in Section 3.173. Any supplements containing > 50 mcg of selenium are disallowed. Pt must not have any concurrent cancers or any prior cancer history within the past 5 yrs except localized non-melanoma skin cancer. Pts must have no synchronous lesions or mets even if resectable. Pt must have no history of greater than one lung cancer primary at any time.

Activation Date: 12/1/2000
Closure Date: 11/5/2009

line
 
     
SWOG Logo Disclaimer | Copyright ©2000-2010 SWOG. All rights reserved.
Design by nuMedia Group Inc. | Hosting by WorldPost Technologies, Inc.
SWOG is FISMA CertifiedSWOG is FISMA Certified