Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00193310
Status:
COMPLETED
Last Update Posted:
2015-03-18
First Post:
2005-09-12
Brief Title:
Preoperative or Postoperative Therapy of Patients With Stages IB II IIIA Non-Small Cell Lung Cancer
Sponsor:
SCRI Development Innovations LLC
Organization:
SCRI Development Innovations LLC
Study Overview
Official Title:
Preoperative Neoadjuvant or Postoperative Adjuvant Therapy of Patients With Stages IB II IIIA Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2015-03
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:
In this phase II study we plan to evaluate several novel components of therapy In patients with potentially resectable stages IIB T3N0 and IIIA we will compare weekly paclitaxel and carboplatin with concomitant radiation therapy versus weekly paclitaxel and every 4 week carboplatin in the preoperative neoadjuvant setting For patients with potentially resectable stage IB IIA and IIB T2N1 tumors weekly paclitaxel and every 4 week carboplatin will be given pre-operatively neoadjuvant The feasibility of resection will be evaluated in the neoadjuvant group of patients The continued study of concurrent radiation therapy with weekly paclitaxel and carboplatin will be evaluated in those patients with stage IIB T3N0 and IIIA disease who initially had resection adjuvant setting Lastly weekly paclitaxel and carboplatin every 4 weeks will be evaluated as an adjuvant program in patients who had completely resected stage IB IIA and IIB T2N1
Detailed Description:
Upon determination of eligibility neo-adjuvant patients will be randomly assigned to one of two treatment arms
ARM A Paclitaxel Carboplatin Radiation Therapy Surgery
ARM B Paclitaxel Carboplatin Surgery
After surgery neo-adjuvant patients with a complete resection will either receive Paclitaxel Carboplatin or no therapy depending on their stage of disease at time of enrollment Patients with incomplete resection Paclitaxel Carboplatin Radiation Therapy Adjuvant patients who enter the study after complete resection will receive Paclitaxel Carboplatin with or without Radiation Therapy based on initial stage of disease
ARM A Paclitaxel Carboplatin Radiation Therapy Surgery
ARM B Paclitaxel Carboplatin Surgery
After surgery neo-adjuvant patients with a complete resection will either receive Paclitaxel Carboplatin or no therapy depending on their stage of disease at time of enrollment Patients with incomplete resection Paclitaxel Carboplatin Radiation Therapy Adjuvant patients who enter the study after complete resection will receive Paclitaxel Carboplatin with or without Radiation Therapy based on initial stage of disease
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