Induction Gemcitabine & Carboplatin Followed by Paclitaxel & Carboplatin +XRT in NSCLC
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00226590|
Recruitment Status : Completed
First Posted : September 27, 2005
Results First Posted : May 23, 2011
Last Update Posted : March 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: Gemcitabine Drug: Carboplatin Drug: Paclitaxel Procedure: Radiation||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Induction Gemcitabine and Carboplatin Followed by Paclitaxel and Carboplatin With Concurrent Thoracic Radiation for Patients With Unresectable Stage IIIA/IIIB Non-Small Cell Lung Cancer|
|Study Start Date :||April 2003|
|Primary Completion Date :||July 2008|
|Study Completion Date :||July 2008|
Experimental: Combined Therapy
In this trial we adopted the approach of using both induction and concurrent chemotherapy together with TRT planned conformally to a tumor dose of 74 Gy.
Other Name: GemzarDrug: Carboplatin
Induction Chemotherapy. Weekly Carboplatin and Paclitaxel During Thoracic Radiation Therapy.
Other Name: ParaplatinDrug: Paclitaxel
Weekly Carboplatin and Paclitaxel During Thoracic Radiation Therapy.
Other Name: TaxolProcedure: Radiation
Radiation Therapy will begin on day 57 if there has been adequate hematologic recovery from Induction Chemotherapy.
Other Name: Radiation Therapy
- Number of Participants Whose Response Allowed Them to Proceed to Chemoradiation [ Time Frame: Ranging from 2 weeks up to 4 years, 9 months ]Response Rates - Complete Response (CR) + Partial Response (PR): We determined the number of participants whose response (both CT and PET assessment) to two cycles of induction chemotherapy with gemcitabine and carboplatin allowed them to proceed to chemoradiation. Response was evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee.
- Progression Free Survival [ Time Frame: Ranging from 2 weeks up to 4 years, 9 months ]To determine median Progression Free Survival rate. Progression-free survival (PFS) is defined as the interval between the date of the first chemotherapy administration and the date of objective progression or death. Progression was evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee.
- Overall Survival [ Time Frame: Ranging from 2 weeks up to 4 years, 9 months ]To determine median Overall Survival rate
- Treatment Completion [ Time Frame: Ranging from 2 weeks up to 4 years, 9 months ]The number of participants who completed all treatment on schedule without dose reductions or delays.
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): NCT00226590
|United States, Florida|
|H. Lee Moffitt Cancer Center & Research Insitute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Gerold Bepler, MD, PhD||Karmanos Cancer Institute (formerly at H. Lee Moffitt Cancer Center & Research Institute)|