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
In this trial we adopted the approach of using both induction and concurrent chemotherapy
together with Thoracic Radiation Therapy (TRT) planned conformally to a tumor dose of 74 Gy.
Substitution of gemcitabine for paclitaxel in the induction chemotherapy allowed us to
evaluate the impact of RRM1 expression on the activity of this agent. The expression of
Ribonucleotide Reductase, M1 Subunit (RRM1) was evaluated prior to initiation of therapy,
following induction chemotherapy but prior to concurrent chemoradiation, and following
completion of all therapy by CT-guided core needle biopsies. This is a single institution
phase II clinical trial, of induction treatment with gemcitabine and carboplatin followed by
concurrent chemoradiation using paclitaxel and carboplatin and daily thoracic radiation to a
total dose of 74 Gy for patients with unresectable Stage IIIA and IIIB NSCLC. The specific
clinical objectives of this study are as follows: To determine the response rate (both CT
scan and PET scan assessment) to two cycles of induction chemotherapy with gemcitabine and
carboplatin; To determine the response rate (both CT scan and PET scan assessment) to
concurrent thoracic radiation and weekly paclitaxel and carboplatin; To evaluate the
patterns of local and distant failure for patients treated with induction chemotherapy
followed by concurrent chemoradiation according to this regimen; To estimate the median, 1
year, and overall survival; To assess acute and long term toxicities of treatment.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants Whose Response Allowed Them to Proceed to Chemoradiation
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.
Ranging from 2 weeks up to 4 years, 9 months
No
Gerold Bepler, MD, PhD
Principal Investigator
Karmanos Cancer Institute (formerly at H. Lee Moffitt Cancer Center & Research Institute)
United States: Food and Drug Administration
MCC-13240
NCT00226590
April 2003
July 2008
Name | Location |
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H. Lee Moffitt Cancer Center & Research Insitute | Tampa, Florida 33612 |