Ignite Creation Date:
2024-05-05 @ 11:48 PM
Last Modification Date:
2024-10-26 @ 10:40 AM
Study NCT ID:
NCT01426646
Status:
UNKNOWN
Last Update Posted:
2012-01-05
First Post:
2011-01-18
Brief Title:
S-1 Versus S-1 Plus Cisplatin as an Adjuvant Chemotherapy to Treat Gastric Cancer
Sponsor:
Kyungpook National University Hospital
Organization:
Kyungpook National University Hospital
Study Overview
Official Title:
Randomized Multicenter Phase II Trial of S-1 Versus S-1 Plus Cisplatin as an Adjuvant Chemotherapy After Curative Resection of Stage II-IVM0 Gastric Cancer
Status:
UNKNOWN
Status Verified Date:
2012-01
Last Known Status:
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:
Although there has been some progress in chemotherapy for metastatic gastric cancer no standard regimen of adjuvant chemotherapy is available and many clinical trials have produced contradictory results The majority of randomized clinical trials studying adjuvant chemotherapy in gastric cancer have been underpowered involved low-volume centers or used ineffective chemotherapy regimens As a result well-designed multicenter trials are still needed The ACTS-GC trial which demonstrated the efficacy of S-1 for stage II-III gastric cancer patients who underwent curative resection with extended lymph-node dissection D2 may be valid in countries where D2 surgery is considered the standard of care S-1 improved the 3-year overall survival from 701 for surgery alone to 801 However 3-year overall survival in stage IIIA and stage IIIB patients receiving S-1 were 774 and 634 respectively which are less satisfactory compared to the rate for stage II 907 Based on the unsatisfactory outcome among later stage patients in the ACTS-GC adjuvant trial further investigation is needed for more effective postoperative treatment of patients with stage IIIB and IV M0 cancer Therefore the researchers investigated the efficacy and safety of S-1 versus S-1 plus cisplatin as adjuvant chemotherapy in patient with curatively resected gastric adenocarcinoma
Detailed Description:
This controlled study is designed to evaluate the efficacy of S-1 on survival compared with S-1 plus cisplatin Patients will be randomly assigned to receive either surgery followed by treatment with S-1 plus cisplatin or surgery followed by treatment with S-1 within 42 days after curative resection To assess the efficacy data on recurrence and survival will be collected from the time of enrollment until 5 years after surgery To evaluate safety data on adverse events will be collected from the time of enrollment until 1 year after surgery
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