Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004873
Status:
COMPLETED
Last Update Posted:
2012-05-15
First Post:
2000-03-07
Brief Title:
Combination Chemotherapy in Treating Patients With Advanced Stomach Cancer
Sponsor:
Swiss Group for Clinical Cancer Research
Organization:
Swiss Group for Clinical Cancer Research
Study Overview
Official Title:
Taxotere-Cisplatin-5FU TCF Versus Taxotere-Cisplatin TC Versus Epirubicin-Cisplatin-5FU ECF as Systemic Treatment for Advanced Gastric Carcinoma A Randomized Phase II Trial
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 drug may kill more tumor cells It is not yet known which combination chemotherapy regimen is most effective in treating advanced stomach cancer
PURPOSE Randomized phase II trial to compare the effectiveness of different regimens of combination chemotherapy in treating patients who have advanced stomach cancer
PURPOSE Randomized phase II trial to compare the effectiveness of different regimens of combination chemotherapy in treating patients who have advanced stomach cancer
Detailed Description:
OBJECTIVES
Compare the efficacy and tolerability of docetaxel cisplatin and fluorouracil TCF versus docetaxel and cisplatin TC versus epirubicin cisplatin and fluorouracil ECF in patients with advanced gastric carcinoma
Compare the time to treatment failure time to progression and survival in this patient population treated with these regimens
Compare the quality of life during the treatment period and after failure in this patient population
OUTLINE This is a randomized multicenter study Patients are stratified according to center performance status 0 vs 1 and liver involvement yes vs no Patients are randomized to one of three treatment arms
Arm I Patients receive epirubicin IV bolus and cisplatin IV over 4 hours on day 1 plus fluorouracil IV continuously on days 1-21
Arm II Patients receive docetaxel IV over 1 hour and cisplatin IV over 4 hours on day 1
Arm III Patients receive docetaxel and cisplatin as in arm II and fluorouracil as in arm I
Treatment regimen is repeated every 3 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed before randomization at day 1 of courses 2 4 and 6 and one month after treatment failure
Patients with complete response or partial response are followed monthly for 3 months
PROJECTED ACCRUAL Approximately 111 patients will be accrued for this study
Compare the efficacy and tolerability of docetaxel cisplatin and fluorouracil TCF versus docetaxel and cisplatin TC versus epirubicin cisplatin and fluorouracil ECF in patients with advanced gastric carcinoma
Compare the time to treatment failure time to progression and survival in this patient population treated with these regimens
Compare the quality of life during the treatment period and after failure in this patient population
OUTLINE This is a randomized multicenter study Patients are stratified according to center performance status 0 vs 1 and liver involvement yes vs no Patients are randomized to one of three treatment arms
Arm I Patients receive epirubicin IV bolus and cisplatin IV over 4 hours on day 1 plus fluorouracil IV continuously on days 1-21
Arm II Patients receive docetaxel IV over 1 hour and cisplatin IV over 4 hours on day 1
Arm III Patients receive docetaxel and cisplatin as in arm II and fluorouracil as in arm I
Treatment regimen is repeated every 3 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed before randomization at day 1 of courses 2 4 and 6 and one month after treatment failure
Patients with complete response or partial response are followed monthly for 3 months
PROJECTED ACCRUAL Approximately 111 patients 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-99021 | None | None | None |
| SWS-SAKK-4299 | None | None | None |