Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00226590
Status:
COMPLETED
Last Update Posted:
2017-03-23
First Post:
2005-09-23
Brief Title:
Induction Gemcitabine Carboplatin Followed by Paclitaxel Carboplatin XRT in NSCLC
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
Phase II Trial of Induction Gemcitabine and Carboplatin Followed by Paclitaxel and Carboplatin With Concurrent Thoracic Radiation for Patients With Unresectable Stage IIIAIIIB Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2011-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single institution Phase II study for patients with unresectable Stage IIIA and IIIB non-small cell lung cancer The treatment started with 2 cycles of gemcitabine and carboplatin followed by concurrent chemotherapy with radiation The chemoradiation included using paclitaxel and carboplatin with daily thoracic radiation to a total dose of 74 Gy Response rate was determined following the chemotherapy with gemcitabine and carboplatin and evaluated again after the chemoradiation Treatment toxicities were also assessed
Detailed Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 13189 | OTHER_GRANT | NCI | None |