Status:
COMPLETED
Preoperative or Postoperative Therapy of Patients With Stages IB, II, IIIA Non-Small Cell Lung Cancer
Lead Sponsor:
SCRI Development Innovations, LLC
Collaborating Sponsors:
Bristol-Myers Squibb
Eli Lilly and Company
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
In this phase II study, we plan to evaluate several novel components of therapy. In patients with potentially resectable stages IIB (T3N0) and IIIA we will compare weekly paclitaxel and carboplatin wi...
Detailed Description
Upon determination of eligibility, neo-adjuvant patients will be randomly assigned to one of two treatment arms: * ARM A Paclitaxel + Carboplatin + Radiation Therapy + Surgery * ARM B Paclitaxel + Ca...
Eligibility Criteria
Inclusion
- To be included in this study, you must meet the following criteria:
- Non-small cell lung cancer
- Neoadjuvant candidates must have potentially resectable disease
- Adjuvant candidates must have had complete resection
- Clinical stage IB, II, or IIIA non-small cell lung cancer
- ECOG performance status 0 or 1
- Adequate bone marrow, liver and kidney function
- No previous chemotherapy or radiation therapy for non-small cell lung cancer.
- Give written informed consent.
Exclusion
- You cannot participate in this study if any of the following apply to you:
- Stage IIIA with N2 nodes \> 6 cm
- Stage IIIB or IV disease
- Age \<18 years
- ECOG performance status 2 or higher
- Considered inoperable based on general medical condition
- History of prior malignancy within five years
- Women who are pregnant or lactating
- 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.
Key Trial Info
Start Date :
November 1 2000
Trial Type :
INTERVENTIONAL
End Date :
January 1 2009
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT00193310
Start Date
November 1 2000
End Date
January 1 2009
Last Update
March 18 2015
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