- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00193427
Preoperative Therapy in Patients With Stages IB, II, IIIA, and Selected IIIB Patients With Non-Small Cell Lung Cancer
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37023
- Tennessee Oncology, PLLC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Patients with potentially resectable clinical stage IB, II, and selected III NSCLC received gemcitabine 1000 mg/m2 days 1, 8 and docetaxel 30 mg/m2 days 1, 8 every 21 days for 3 cycles.
Patients were restaged after treatment and resected 3-6 weeks later.
If patients were inoperable, had incomplete resections or N2 disease, docetaxel 20 mg/m2 and carboplatin AUC = 1.5 weekly x 7 and radiation to 63 Gy was administered
|
30mg/m2 administered on days 1 and 8, 21-cycle days, 3 cycles
Other Names:
1000 mg/m2 administered by 30-minute IV infusion on day 1 and 8, 21-cycle days, 3 cycles
Other Names:
AUC = 1.5 weekly x 7
Other Names:
To 63 Gy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pathologic Complete Response Rate
Time Frame: 18 months
|
A pathological complete response (pCR) was defined as having no residual cancer at the primary site or in regional lymph nodes on pathologic review.
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression Free Survival (PFS)
Time Frame: 19 months
|
Progression-free survival was calculated as the elapsed time between the date of study registration and the date of recurrence or death from any cause.
|
19 months
|
Overall Response Rate (ORR)
Time Frame: 18 months
|
Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria.
Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks.
Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters.
|
18 months
|
Overall Survival (OS)
Time Frame: 18 months
|
Overall survival was calculated as the elapsed time bewteen date of study registration and the date of death.
|
18 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Lung Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Gemcitabine
- Docetaxel
- Carboplatin
Other Study ID Numbers
- SCRI LUN 76
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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