Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002615
Status:
COMPLETED
Last Update Posted:
2013-12-19
First Post:
1999-11-01
Brief Title:
Surgery With or Without Combination Chemotherapy in Treating Patients With Stomach Cancer
Sponsor:
Medical Research Council
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A RANDOMISED CONTROLLED TRIAL OF PRE- AND POST-OPERATIVE CHEMOTHERAPY IN PATIENTS WITH OPERABLE GASTRIC CANCER
Status:
COMPLETED
Status Verified Date:
2001-08
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells It is not known whether receiving chemotherapy before surgery may be more effective than surgery alone in treating patients with stomach cancer
PURPOSE Randomized phase III trial to compare the effectiveness of surgery plus combination chemotherapy with surgery alone in treating patients with stomach cancer
PURPOSE Randomized phase III trial to compare the effectiveness of surgery plus combination chemotherapy with surgery alone in treating patients with stomach cancer
Detailed Description:
OBJECTIVES
Compare the survival and quality of life of patients with resectable stage II or III adenocarcinoma of the stomach treated with epirubicin cisplatin and fluorouracil before and after resection vs resection alone
Determine the effect of perioperative chemotherapy on the resectability of gastric cancer in these patients
OUTLINE This is a randomized multicenter study Patients are stratified by center and performance status 0 vs 1
Arm I Patients undergo radical total gastrectomy or radical subtotal distal gastrectomy at the discretion of the surgeon with perigastric lymph node dissection Patients also may undergo lymphadenectomy at the discretion of the surgeon At the beginning of the laparotomy a pre-aortic infra-colic node is sampled for staging purposes and frozen sections are examined during surgery Patients who are found to have metastatic disease undergo palliative resection at the discretion of the surgeon and postoperative chemotherapy at the discretion of the oncologist
Arm II Patients receive fluorouracil 5-FU IV continuously for 3 weeks and cisplatin IV over 4 hours beginning 4 hours after initiation of 5-FU infusion and epirubicin IV on day 1 ECF Treatment continues every 3 weeks for 3 courses Within 6 weeks after completion of course 3 and when blood counts recover patients undergo resection as in arm I Beginning within 4-6 weeks after surgery patients receive 3 additional courses of ECF
Quality of life is assessed at baseline at completion of study therapy and then every 6 months for 2 years
Patients are followed every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 500 patients will be accrued for this study within 4 years
Compare the survival and quality of life of patients with resectable stage II or III adenocarcinoma of the stomach treated with epirubicin cisplatin and fluorouracil before and after resection vs resection alone
Determine the effect of perioperative chemotherapy on the resectability of gastric cancer in these patients
OUTLINE This is a randomized multicenter study Patients are stratified by center and performance status 0 vs 1
Arm I Patients undergo radical total gastrectomy or radical subtotal distal gastrectomy at the discretion of the surgeon with perigastric lymph node dissection Patients also may undergo lymphadenectomy at the discretion of the surgeon At the beginning of the laparotomy a pre-aortic infra-colic node is sampled for staging purposes and frozen sections are examined during surgery Patients who are found to have metastatic disease undergo palliative resection at the discretion of the surgeon and postoperative chemotherapy at the discretion of the oncologist
Arm II Patients receive fluorouracil 5-FU IV continuously for 3 weeks and cisplatin IV over 4 hours beginning 4 hours after initiation of 5-FU infusion and epirubicin IV on day 1 ECF Treatment continues every 3 weeks for 3 courses Within 6 weeks after completion of course 3 and when blood counts recover patients undergo resection as in arm I Beginning within 4-6 weeks after surgery patients receive 3 additional courses of ECF
Quality of life is assessed at baseline at completion of study therapy and then every 6 months for 2 years
Patients are followed every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 500 patients will be accrued for this study within 4 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-94035 | None | None | None |
| MRC-ST02 | None | None | None |