Clinical Trials
A Randomized Phase III Trial of Adjuvant Therapy in Early Stage Non-Small Cell Lung Cancer Evaluating the Potential Utility of a Genomic Prognostic Model to Identify Patients as Candidates for Adjuvant Chemotherapy
IRB-HSR# 14447
Service:
Cancer
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Category: Cancer (Oncology), Surgery
Adult Enrollment: No
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Minor Enrollment: No
Primary Investigator: David R. Jones, M.D.
Contact Information
Contact: Sandra Burks
Phone: 434.243.0315
E-mail: sgb2c@virginia.edu
Clinical Trial Description
UVA Health System, Division of Thoracic Surgery seeks patients with Early Stage Lung Cancer for research study.
The purpose of the study is to look at a new laboratory test to see if the results of the test can tell us whether or not a tumor will recur. The laboratory test works by studying hundreds of genes in your tumor tissue. We think that, in certain patients, chemotherapy after surgery may lessen the chances of the tumor recurring. However, we do not know which patients may benefit from chemotherapy following surgery and which will not. In the future, we may be able to use this test to decide if patients would benefit from chemotherapy in addition to surgery, while improving cancer care.
The study involves obtaining a tissue sample of tumor removed by the surgeon on the day of surgery. This tissue sample will be used for the new experimental laboratory test. Once it is determined that a patient is eligible for the study, randomization will take place. Patients will either be randomized to receive Observation after surgery OR randomized to receive Chemotherapy after surgery. The Observation patients will receive no further treatment for their tumor and will be seen in clinic every 6 months for 5 years. The Chemotherapy patients will receive 4 cycles of chemotherapy with each cycle lasting 21 days and will then be seen in clinic every 4 months for the first 2 years and then every 6 months for years 3-5.
This study is being sponsored by the Cancer and Leukemia Group B which is a part of the National Cancer Institute.
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