Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00176137
Status:
COMPLETED
Last Update Posted:
2008-04-22
First Post:
2005-09-13
Brief Title:
Preoperative Twice Daily Chemoradiation in Addition to Chemotherapy Prior to Surgery in Stage III Non-Small Cell Lung Cancer NSCLC
Sponsor:
Heidelberg University
Organization:
Heidelberg University
Study Overview
Official Title:
CisplatinEtoposide Followed by Twice-Daily Chemoradiation hfRTCT Versus CisplatinEtoposide Alone Before Surgery in Stage III Non-Small Cell Lung Cancer A Phase III Trial of the German Lung Cancer Cooperative Group GLCCG
Status:
COMPLETED
Status Verified Date:
2008-04
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:
Patients are randomized to arm A 3 cycles of cisplatinetoposide followed by hyperfractionated radiotherapy hfRTwith concurrent carboplatin and vindesine then surgery and if no or R12-resection additional hfRT versus arm B 3 cycles of cisplatinetoposide followed by surgery and then RT
The primary endpoint was progression free survival PFS With 500 patients evaluable an improvement of median PFS from 10 to 14 months could be detected
The primary endpoint was progression free survival PFS With 500 patients evaluable an improvement of median PFS from 10 to 14 months could be detected
Detailed Description:
Patients are randomized to arm A 3 cycles of cisplatin 55 mgm2 d 1 4etoposide 100 mgm2 d 1-4 followed by hyperfractionated radiotherapy hfRT 45 Gy 2x15 Gyd with concurrent carboplatin 100 mgm2 and vindesine 3 mg d 1 8 15 then surgery and if no or R12-resection additional hfRT 24 Gy 2x15 Gyd versus arm B 3 cycles of cisplatin 55 mgm2 d 1 4etoposide 100 mgm2 d 1-4followed by surgery and then RT 18 Gyd with 54 Gy or if no or R12-resection 684 Gy
The primary endpoint was progression free survival PFS With 500 patients evaluable an improvement of median PFS from 10 to 14 months could be detected
University of Münster was the lead sponsor as the trial was implemented in clinicaltrialsgov by the principal investigator after he had moved to University of Heidelberg this account is announced above
The primary endpoint was progression free survival PFS With 500 patients evaluable an improvement of median PFS from 10 to 14 months could be detected
University of Münster was the lead sponsor as the trial was implemented in clinicaltrialsgov by the principal investigator after he had moved to University of Heidelberg this account is announced above
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 |
|---|---|---|---|
| German Cancer Aid | None | None | None |