|
Combination Chemotherapy in Treating Patients With Stage III Breast Cancer Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on Combination Chemotherapy in Treating Patients With Stage III Breast Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Combination Chemotherapy in Treating Patients With Stage III Breast Cancer Clinical research trials and Combination Chemotherapy in Treating Patients With Stage III Breast Cancer healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like Combination Chemotherapy in Treating Patients With Stage III Breast Cancer. Combination Chemotherapy in Treating Patients With Stage III Breast Cancer Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Combination Chemotherapy in Treating Patients With Stage III Breast Cancer clinical trial. Human subjects often obtain the finest healthcare possible for their Combination Chemotherapy in Treating Patients With Stage III Breast Cancer condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Patients With Stage III Breast Cancer  Combination Chemotherapy in Treating Patients With Stage III Breast Cancer
Combination Chemotherapy in Treating Patients With Stage III Breast Cancer
For Condition: stage 3A breast cancer,stage 3B breast cancer,stage 3C breast cancer
Status: Suspended
Sponsor(s): Grupo Oncologico Cooperativo del Sur ,
Synopsis: 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: Randomizedphase III trial to compare cyclophosphamide, doxorubicin, and fluorouracil with cyclophosphamide, methotrexate, and fluorouracil in treating women with stage III breast cancer.
Details: OBJECTIVES: - Compare the response in patients 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
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 21 Years/75 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed stage III breast cancer - Measurable disease - No inflammatory breast cancer - No synchronous bilateral breast cancer - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age: - 21 to 75 Sex: - Female Menopausal status: - Not specified Performance status: - ECOG 0-1 OR - Zubrod 0-1 Life expectancy: - More than 12 weeks Hematopoietic: - WBC greater than 4,000/mm^3 - Platelet count greater than 100,000/mm^3 Hepatic: - Bilirubin less than 1.25 times upper limit of normal (ULN) - AST less than 1.25 times ULN Renal: - Creatinine clearance greater than 70 mL/min Cardiovascular: - No angina pectoris - No significant arrhythmia requiring therapy - No bilateral bundle branch block - No congestive heart failure - No myocardial infarction Other: - No medical or psychiatric disease that would preclude study therapy - No other malignancy except adequately treated nonmelanomatous skin cancer or carcinoma in situ of the cervix - Not pregnant PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - Not specified Endocrine therapy: - Not specified Radiotherapy: - No prior radiotherapy Surgery: - No prior surgery except incisional biopsy or fine-needle aspiration Other: - No prior systemic therapy - No concurrent caffeine or alcohol
Total Enrollment:
Location and Contact Information:
Overall Study Official:
BernardoLeone, Study Chair, Unidad Oncologica Del Neuquen
Consultorio Oncologico Privado
Mar del Plata, Buenos Aires, 7600
Argentina
Centro Oncologico Tres Arroyos
Tres Arroyos, , 7500
Argentina
Centro Oncologico Del Litoral
Santa Fe, , 3000
Argentina
Policlinica Privada Instituto De Medicina Nuclear
Bahia Blanca, Buenos Aires, 8000
Argentina
Centro De Oncologia y Terapia Radiante
Santa Rosa, La Pampa, 6300
Argentina
Consultorio Oncologico Privado
Rio Gallegos, , 9400
Argentina
Unidad Oncologica Del Comahue
Neuquen, ,
Argentina
Additional Information:
Study ID Numbers: CDR0000064471; GOCS-08-BR-95-III,NCI-F95-0036
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002696
Other Stage 3c Breast Cancer Studies:
1. Combination Chemotherapy in Treating Women With Breast Cancer That is Metastatic or Cannot be Treated With Surgery
2. Chemotherapy Plus Trastuzumab in Treating Patients With Breast Cancer
3. Neoadjuvant and Adjuvant Exemestane in Treating Postmenopausal Women With Locally Advanced Hormone Receptor-Positive Breast Cancer
4. Combination Chemotherapy in Treating Patients With High-Risk Breast Cancer
5. Raloxifene With or Without Exercise Compared With Exercise Alone in Women Who Have Been Previously Treated for Breast Cancer
Related Studies:
Other stage 3C breast cancer Clinical Trials
Other Clinical Trials
Other Santa Fe Clinical Trials
Combination Chemotherapy in Treating Patients With Stage III Breast Cancer
|
|
|
|
|
|
|
|
