Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00193427
Status:
COMPLETED
Last Update Posted:
2022-03-03
First Post:
2005-09-12
Brief Title:
Preoperative Therapy in Patients With Stages IB II IIIA and Selected IIIB Patients With Non-Small Cell Lung Cancer
Sponsor:
SCRI Development Innovations LLC
Organization:
SCRI Development Innovations LLC
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2022-02
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 trial is designed to study the role of docetaxelgemcitabine 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
Detailed Description:
Upon determination of eligibility patients will receive
Pre-operative
Docetaxel
Gemcitabine Post-operative
Docetaxel
Carboplatin
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
Pre-operative
Docetaxel
Gemcitabine Post-operative
Docetaxel
Carboplatin
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 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