Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00022178
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
2001-08-10
Brief Title:
Combination Chemotherapy in Treating Patients With Metastatic Cancer of an Unknown Site of Origin
Sponsor:
The Christie NHS Foundation Trust
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
An Open Label Prospective Randomised Study Comparing The Use Of Vincristine Adriamycin And Cyclophosphamide VAC Versus Epirubicin Cisplatin And Continuous 5-Flourouracil ECF In Patients With Unknown Primary Carcinoma UPC
Status:
UNKNOWN
Status Verified Date:
2002-02
Last Known Status:
ACTIVE_NOT_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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die It is not yet known which combination chemotherapy regimen is more effective for metastatic cancer of an unknown site of origin
PURPOSE Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have metastatic cancer of an unknown site of origin
PURPOSE Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have metastatic cancer of an unknown site of origin
Detailed Description:
OBJECTIVES I Compare the efficacy of the regimens in terms of tumor response progression-free survival and overall survival of vincristine doxorubicin and cyclophosphamide vs epirubicin cisplatin and fluorouracil in patients with metastatic carcinoma of unknown primary II Compare the toxicity of these regimens in these patients III Compare quality of life and symptom control in patients treated with these regimens
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to presence of liver metastases yes vs no and type of tumor adenocarcinoma vs non-adenocarcinoma Patients are randomized to one of two treatment arms Arm I Patients receive vincristine IV doxorubicin IV and cyclophosphamide IV on day 1 Arm II Patients receive epirubicin IV and cisplatin IV over 4 hours on day 1 and fluorouracil IV continuously on days 1-21 Treatment in both arms repeats every 3 weeks for 3-6 courses in the absence of disease progression or unacceptable toxicity Quality of life is assessed at baseline at the end of courses 2 4 and 6 and 1 month after completion of therapy Patients are followed at 1 month and then until death
PROJECTED ACCRUAL A total of 398 patients 199 per treatment arm will be accrued for this study
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to presence of liver metastases yes vs no and type of tumor adenocarcinoma vs non-adenocarcinoma Patients are randomized to one of two treatment arms Arm I Patients receive vincristine IV doxorubicin IV and cyclophosphamide IV on day 1 Arm II Patients receive epirubicin IV and cisplatin IV over 4 hours on day 1 and fluorouracil IV continuously on days 1-21 Treatment in both arms repeats every 3 weeks for 3-6 courses in the absence of disease progression or unacceptable toxicity Quality of life is assessed at baseline at the end of courses 2 4 and 6 and 1 month after completion of therapy Patients are followed at 1 month and then until death
PROJECTED ACCRUAL A total of 398 patients 199 per treatment 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-20041 | None | None | None |
| CHNT-VAC-VS-ECF | None | None | None |