Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00147147
Status:
COMPLETED
Last Update Posted:
2016-09-22
First Post:
2005-09-05
Brief Title:
Randomized Trial of Adjuvant Chemotherapy With Cisplatin Followed by UFT in Serosa-positive Gastric Cancer JCOG9206-2
Sponsor:
Japan Clinical Oncology Group
Organization:
Japan Clinical Oncology Group
Study Overview
Official Title:
Randomized Trial of Adjuvant Chemotherapy With Cisplatin Followed by Oral Fluorouracil UFT in Serosa-positive Gastric Cancer JCOG9206-2
Status:
COMPLETED
Status Verified Date:
2016-09
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:
To evaluate the survival benefit of adjuvant chemotherapy after curative resection with D2 or greater lymph node dissection in T3-4 gastric cancer patients
Detailed Description:
Purpose To evaluate the survival benefit of adjuvant chemotherapy after curative resection in serosa-positive gastric cancer patients a multicenter phase III clinical trial was conducted by 13 participating centers in Japan Methods From January 1993 to March 1998 268 patients were randomized to either adjuvant chemotherapy 135 pts or surgery alone 133 pts The chemotherapy comprised intraperitoneal cisplatin 70 mgm2 before closing the abdomen and after surgery intravenous cisplatin 70 mgm2 day 14 and 5-fluorouracil 5-FU 700 mgm2 daily day 14-16 and oral FU UFT 267 mgm2 daily from 4 weeks after surgery for the next 12 months The primary endpoint was overall survival Relapse-free survival and the site of recurrence were secondary endpoints
Comparison gastrectomy with D2 or greater lymph node dissection versus gastrectomy with adjuvant chemotherapy after curative resection in serosa-positive gastric cancer patients
Comparison gastrectomy with D2 or greater lymph node dissection versus gastrectomy with adjuvant chemotherapy after curative resection in serosa-positive gastric cancer patients
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 |
|---|---|---|---|
| C000000067 | None | None | None |