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Phase II Trial of Preoperative (Neo-adjuvant) Therapy in Patients With Stages IB, II, IIIA, and Selected IIIB Patients With Non-Small Cell Lung Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

Phase II Trial of Preoperative (Neo-adjuvant) Therapy in Patients With Stages IB, II, IIIA, and Selected IIIB Patients With Non-Small Cell Lung Cancer


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


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pathologic Complete Response Rate

Outcome Description:

A pathological complete response (pCR) was defined as having no residual cancer at the primary site or in regional lymph nodes on pathologic review.

Outcome Time Frame:

18 months

Safety Issue:

No

Principal Investigator

David R. Spigel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sarah Cannon Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

SCRI LUN 76

NCT ID:

NCT00193427

Start Date:

April 2004

Completion Date:

December 2008

Related Keywords:

  • Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location
Tennessee Oncology, PLLC Clarksville, Tennessee  37043