Ignite Creation Date:
2024-05-06 @ 12:17 AM
Last Modification Date:
2024-10-26 @ 10:47 AM
Study NCT ID:
NCT01534546
Status:
UNKNOWN
Last Update Posted:
2019-09-17
First Post:
2012-02-13
Brief Title:
Phase III Study to Compare Perioperative Chemotherapy of Oxaliplatin Combined With S-1SOX Versus SOX or Oxaliplatin With Capecitabine XELOX as Post-operative Chemotherapy in Locally Advanced Gastric Adenocarcinoma With D2 Dissection
Sponsor:
Peking University
Organization:
Peking University
Study Overview
Official Title:
A Randomized Multicenter Controlled Phase III Study to Compare Perioperative Chemotherapy of Oxaliplatin Combined With S-1SOX Versus SOX or Oxaliplatin With Capecitabine XELOX as Post-operative Chemotherapy in Locally Advanced Gastric Adenocarcinoma With D2 Dissection
Status:
UNKNOWN
Status Verified Date:
2019-09
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
Peri-operative treatment of locally advanced gastric cancer LAGC has always been argued by eastern and western scholars For patients with clinical stage of cT4bNM0 or cT4aNM0 the prognosis is rather poor and the primary lesions might not be resectable at the time of diagnosis MAGIC study has showed that pre-and post-operative chemotherapy with 3 cycles of ECF has increased 13 on 5yOS compared with surgery alone However eastern studies such as ACTS GC or CLASSIC showed that TS-1 monotherapy or XELOX oxaliplatincapecitabine combination given as adjuvant chemotherapy for stage II or III patients after D2 surgery could achieve the significant survival benefit So whether perioperative or post operative therapy is more beneficial for LAGC patients lacks of data supported by prospective study
So in this prospective randomized phase III study the investigators aim to compare the survival benefit as well as the safety for SOX oxaliplatinTS-1 as perioperative therapy versus SOX or XELOX as postoperative therapy after D2 dissection
So in this prospective randomized phase III study the investigators aim to compare the survival benefit as well as the safety for SOX oxaliplatinTS-1 as perioperative therapy versus SOX or XELOX as postoperative therapy after D2 dissection
Detailed Description:
detailed discription of protocol updated on Feb 2013 detailed discription of protocol updated on Apr 2013 detailed discription of protocol updated on Oct 2013
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 |
|---|---|---|---|
| CGOG 1003 | OTHER | Chinese Gastrointestinal Oncology Group | None |