Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002696
Status:
SUSPENDED
Last Update Posted:
2013-08-02
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Women With Stage III Breast Cancer
Sponsor:
Grupo Oncologico Cooperativo del Sur
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
MULTIMODALITY TREATMENT STRATEGY FOR STAGE III BREAST CANCER
Status:
SUSPENDED
Status Verified Date:
2008-04
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
PURPOSE Randomized phase III trial to compare cyclophosphamide doxorubicin and fluorouracil with cyclophosphamide methotrexate and fluorouracil in treating women with stage III breast cancer
PURPOSE Randomized phase III trial to compare cyclophosphamide doxorubicin and fluorouracil with cyclophosphamide methotrexate and fluorouracil in treating women with stage III breast cancer
Detailed Description:
OBJECTIVES
Compare the response in women with stage III breast cancer treated with neoadjuvant fluorouracil doxorubicin and cyclophosphamide FAC vs cyclophosphamide methotrexate and fluorouracil CMF
Compare the rates of conservative surgical resectability and locoregional control in patients treated with these neoadjuvant therapy regimens
Compare the disease-free and overall survival of patients treated with these regimens
Compare the toxic effects of these regimens in these patients
Compare the compliance of patients treated with these regimens
Assess the cosmetic results in patients treated with conservative surgery
Compare the quality of life of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center
Arm I Patients receive fluorouracil 5-FU IV on days 1 and 8 and doxorubicin IV and cyclophosphamide CTX IV on day 1 FAC Treatment continues every 3 weeks for 3 courses in the absence of disease progression
Arm II Patients receive CTX IV methotrexate IV and 5-FU IV on days 1 and 8 CMF Treatment continues every 4 weeks for 3 courses in the absence of disease progression
Patients on both arms with resectable disease after the third course of chemotherapy undergo quadrantectomy with axillary node dissection preferred or modified radical mastectomy followed by 6 additional courses of chemotherapy on the arm to which they were randomized initially Those patients without distant metastasis undergo locoregional radiotherapy beginning concurrently with the initiation of postoperative chemotherapy Patients on both arms with unresectable disease after the initial 3 courses of chemotherapy undergo locoregional radiotherapy and then surgical resection if feasible
Quality of life is assessed at baseline and then monthly thereafter
Patients are followed every 3-4 months for 2 years every 4-6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL Not specified
Compare the response in women with stage III breast cancer treated with neoadjuvant fluorouracil doxorubicin and cyclophosphamide FAC vs cyclophosphamide methotrexate and fluorouracil CMF
Compare the rates of conservative surgical resectability and locoregional control in patients treated with these neoadjuvant therapy regimens
Compare the disease-free and overall survival of patients treated with these regimens
Compare the toxic effects of these regimens in these patients
Compare the compliance of patients treated with these regimens
Assess the cosmetic results in patients treated with conservative surgery
Compare the quality of life of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center
Arm I Patients receive fluorouracil 5-FU IV on days 1 and 8 and doxorubicin IV and cyclophosphamide CTX IV on day 1 FAC Treatment continues every 3 weeks for 3 courses in the absence of disease progression
Arm II Patients receive CTX IV methotrexate IV and 5-FU IV on days 1 and 8 CMF Treatment continues every 4 weeks for 3 courses in the absence of disease progression
Patients on both arms with resectable disease after the third course of chemotherapy undergo quadrantectomy with axillary node dissection preferred or modified radical mastectomy followed by 6 additional courses of chemotherapy on the arm to which they were randomized initially Those patients without distant metastasis undergo locoregional radiotherapy beginning concurrently with the initiation of postoperative chemotherapy Patients on both arms with unresectable disease after the initial 3 courses of chemotherapy undergo locoregional radiotherapy and then surgical resection if feasible
Quality of life is assessed at baseline and then monthly thereafter
Patients are followed every 3-4 months for 2 years every 4-6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL Not specified
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 |
|---|---|---|---|
| NCI-F95-0036 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000064471 | REGISTRY | None | None |