Lung Cancer Clinical Trial
Preoperative Therapy in Patients With Stages IB, II, IIIA, and Selected IIIB Patients With Non-Small Cell Lung Cancer
Summary
This trial is designed to study the role of docetaxel/gemcitabine, an active and relatively non-toxic combination in advanced NSCLC. This study will help to better define optimal preoperative regimens for patients with resectable NSCLC. Since both of these drugs are potent radio-sensitizers, the concurrent use with radiation therapy at these weekly doses may produce not only radio-sensitization, but also considerable antitumor efficacy.
Full Description
Upon determination of eligibility, patients will receive:
Pre-operative
Docetaxel
Gemcitabine Post-operative
Docetaxel
Carboplatin
Radiation Therapy
Patients with stage IB and II NSCLC who achieved clear margins will not receive any further therapy. Patients with incomplete resection, resection margins of a T3 tumor that are positive or close, stage IIIA AND IIIB NSCLC or disease judged unresectable after preoperative chemotherapy will receive postoperative treatment
Eligibility Criteria
Inclusion Criteria:
To be included in this study, you must meet the following criteria:
Histologically confirmed non-small cell lung cancer
Must be operable candidate
Clinical stage IB, II, and select III non-small cell lung cancer are eligible
Measurable or evaluable disease
Able to perform activities of daily living with minimal assistance
Must be > 18 years of age
Adequate bone marrow, liver or kidney
No previous chemotherapy or radiation therapy for non-small cell lung cancer
Moderate to severe peripheral neuropathy
Understand the nature of this study and give written informed consent.
Exclusion Criteria:
You cannot participate in this study if any of the following apply to you:
Stage IV disease
History of prior malignancy within five years
Women who are pregnant or breast-feeding
Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
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There is 1 Location for this study
Nashville Tennessee, 37023, United States
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