Preoperative Therapy in Patients With Stages IB, II, IIIA, and Selected IIIB Patients With Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00193427|
Recruitment Status : Completed
First Posted : September 19, 2005
Results First Posted : November 13, 2012
Last Update Posted : November 13, 2012
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: Docetaxel Drug: Gemcitabine Drug: Carboplatin Radiation: Radiation||Phase 2|
Upon determination of eligibility, patients will receive:
- Gemcitabine Post-operative
- 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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||76 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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 Start Date :||April 2004|
|Actual Primary Completion Date :||November 2008|
|Actual Study Completion Date :||December 2008|
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 Name: Taxotere
1000 mg/m2 administered by 30-minute IV infusion on day 1 and 8, 21-cycle days, 3 cycles
Other Name: Gemzar
AUC = 1.5 weekly x 7
Other Name: Paraplatin
To 63 Gy
- 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.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00193427
|United States, Tennessee|
|Tennessee Oncology, PLLC|
|Nashville, Tennessee, United States, 37023|
|Principal Investigator:||David R. Spigel, MD||SCRI Development Innovations, LLC|