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.

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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

View Eligibility Criteria

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.

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

75

Study ID:

NCT00193427

Recruitment Status:

Completed

Sponsor:

SCRI Development Innovations, LLC

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There is 1 Location for this study

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Tennessee Oncology, PLLC
Nashville Tennessee, 37023, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

75

Study ID:

NCT00193427

Recruitment Status:

Completed

Sponsor:


SCRI Development Innovations, LLC

How clear is this clinincal trial information?

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