Preoperative Therapy in Patients With Stages IB, II, IIIA, and Selected IIIB Patients With Non-Small Cell Lung Cancer
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Pathologic Complete Response Rate [ Time Frame: 18 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Overall survival was calculated as the elapsed time bewteen date of study registration and the date of death.
|Study Start Date:||April 2004|
|Study Completion Date:||December 2008|
|Primary Completion Date:||November 2008 (Final data collection date for primary outcome measure)|
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: TaxotereDrug: Gemcitabine
1000 mg/m2 administered by 30-minute IV infusion on day 1 and 8, 21-cycle days, 3 cycles
Other Name: GemzarDrug: Carboplatin
AUC = 1.5 weekly x 7
Other Name: ParaplatinRadiation: Radiation
To 63 Gy
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
|United States, Tennessee|
|Tennessee Oncology, PLLC|
|Nashville, Tennessee, United States, 37023|
|Principal Investigator:||David R. Spigel, MD||SCRI Development Innovations, LLC|