Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00055679
Status:
COMPLETED
Last Update Posted:
2013-06-18
First Post:
2003-03-06
Brief Title:
Combination Chemotherapy in Treating Women With Stage I Breast Cancer
Sponsor:
UNICANCER
Organization:
UNICANCER
Study Overview
Official Title:
Phase III Randomized Study Of Adjuvant Fluourouracil Epirubicin And Cyclophosphamide In Women With Stage I Breast Cancer
Status:
COMPLETED
Status Verified Date:
2013-06
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 more effective in treating early breast cancer
PURPOSE Randomized phase III trial to determine the effectiveness of different regimens of combination chemotherapy in treating women who have stage I breast cancer
PURPOSE Randomized phase III trial to determine the effectiveness of different regimens of combination chemotherapy in treating women who have stage I breast cancer
Detailed Description:
OBJECTIVES
Compare the efficacy of 4 vs 6 courses of adjuvant fluorouracil epirubicin and cyclophosphamide in terms of 5-year survival in women with stage I breast cancer
Compare the toxicity of these regimens in these patients
Determine the correlation of length of survival with biological factors in patients treated with these regimens
Determine biological factors significant for prognosis and prediction of survival of patients treated with these regimens
Determine the overall survival of patients treated with these regimens
OUTLINE This is a randomized open-label multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive fluorouracil IV epirubicin IV and cyclophosphamide IV on day 1 Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients receive the same regimen as in arm I for up to 4 courses After completion of chemotherapy patients undergo radiotherapy 5 days a week for 6 weeks Patients who are estrogen or progesterone receptor positive also receive oral tamoxifen daily for 5 years beginning after completion of chemotherapy
Patients are followed every 6 months for 5 years
PROJECTED ACCRUAL A total of 1512 patients 756 per treatment arm will be accrued for this study within 3 years
Compare the efficacy of 4 vs 6 courses of adjuvant fluorouracil epirubicin and cyclophosphamide in terms of 5-year survival in women with stage I breast cancer
Compare the toxicity of these regimens in these patients
Determine the correlation of length of survival with biological factors in patients treated with these regimens
Determine biological factors significant for prognosis and prediction of survival of patients treated with these regimens
Determine the overall survival of patients treated with these regimens
OUTLINE This is a randomized open-label multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive fluorouracil IV epirubicin IV and cyclophosphamide IV on day 1 Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients receive the same regimen as in arm I for up to 4 courses After completion of chemotherapy patients undergo radiotherapy 5 days a week for 6 weeks Patients who are estrogen or progesterone receptor positive also receive oral tamoxifen daily for 5 years beginning after completion of chemotherapy
Patients are followed every 6 months for 5 years
PROJECTED ACCRUAL A total of 1512 patients 756 per treatment arm will be accrued for this study within 3 years
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-20239 | None | None | None |
| FRE-FNCLCC-PACS-050106 | None | None | None |