Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005060
Status:
COMPLETED
Last Update Posted:
2012-05-15
First Post:
2000-04-06
Brief Title:
Combination Chemotherapy and Surgery in Treating Patients With Locally Advanced Stomach Cancer
Sponsor:
Swiss Group for Clinical Cancer Research
Organization:
Swiss Group for Clinical Cancer Research
Study Overview
Official Title:
A Phase III Trial of Preoperative vs Postoperative Chemotherapy With Taxotere-Cisplatin-5FU TCF in Patients With Locally Advanced Operable Gastric Carcinoma
Status:
COMPLETED
Status Verified Date:
2012-05
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 chemotherapy drug with surgery may kill more tumor cells It is not yet known if chemotherapy followed by surgery is more effective than surgery followed by chemotherapy for stomach cancer
PURPOSE This randomized phase III trial is studying surgery followed by combination chemotherapy to see how well it works compared to combination chemotherapy followed by surgery in treating patients with locally advanced stomach cancer
PURPOSE This randomized phase III trial is studying surgery followed by combination chemotherapy to see how well it works compared to combination chemotherapy followed by surgery in treating patients with locally advanced stomach cancer
Detailed Description:
OBJECTIVES
Compare by intention to treat analysis feasibility and efficacy of 4 courses of docetaxel cisplatin and fluorouracil as preoperative or postoperative chemotherapy in patients with locally advanced operable gastric carcinoma
Evaluate the predictive values of some biological and molecular tumor parameters on response to chemotherapy metastasis and survival in this patient population
OUTLINE This is a randomized open label multicenter study Patients are stratified according to study center tumor site affecting the Z-line cardia carcinoma Siewart II and III vs rest of the stomach and nodal status positive vs negative Patients are randomized to either preoperative chemotherapy followed by surgery arm I or surgery followed by postoperative chemotherapy arm II
Arm I Patients receive docetaxel IV over 1 hour followed by cisplatin IV over 4 hours on day 1 and fluorouracil IV continuously on days 1-14 every 3 weeks Patients are evaluated after 2 courses and patients with progressive disease proceed to immediate surgery Otherwise treatment continues for a total of 4 courses in the absence of unacceptable toxicity or disease progression Between 3-5 weeks following day 1 of the last course of chemotherapy patients undergo gastric resection
Arm II Patients undergo immediate gastric resection Beginning 3-6 weeks after surgery patients receive 4 courses of docetaxel cisplatin and fluorouracil as in arm I
Quality of life is assessed before the first and third courses of chemotherapy before and after surgery and then at 1 3 and 6 months
Patients are followed every 3 months for 3 years every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL Approximately 240 patients 120 per arm will be accrued for this study
Compare by intention to treat analysis feasibility and efficacy of 4 courses of docetaxel cisplatin and fluorouracil as preoperative or postoperative chemotherapy in patients with locally advanced operable gastric carcinoma
Evaluate the predictive values of some biological and molecular tumor parameters on response to chemotherapy metastasis and survival in this patient population
OUTLINE This is a randomized open label multicenter study Patients are stratified according to study center tumor site affecting the Z-line cardia carcinoma Siewart II and III vs rest of the stomach and nodal status positive vs negative Patients are randomized to either preoperative chemotherapy followed by surgery arm I or surgery followed by postoperative chemotherapy arm II
Arm I Patients receive docetaxel IV over 1 hour followed by cisplatin IV over 4 hours on day 1 and fluorouracil IV continuously on days 1-14 every 3 weeks Patients are evaluated after 2 courses and patients with progressive disease proceed to immediate surgery Otherwise treatment continues for a total of 4 courses in the absence of unacceptable toxicity or disease progression Between 3-5 weeks following day 1 of the last course of chemotherapy patients undergo gastric resection
Arm II Patients undergo immediate gastric resection Beginning 3-6 weeks after surgery patients receive 4 courses of docetaxel cisplatin and fluorouracil as in arm I
Quality of life is assessed before the first and third courses of chemotherapy before and after surgery and then at 1 3 and 6 months
Patients are followed every 3 months for 3 years every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL Approximately 240 patients 120 per arm will be accrued for this study
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 |
|---|---|---|---|
| EU-99042 | Other Identifier | SAKK | None |
| SWS-SAKK-4399 | OTHER | None | None |