Paclitaxel Plus Radiation Therapy in Treating Women With Stage II or Stage III Breast Cancer
This trial is active, not recruiting.
|Treatments||paclitaxel, adjuvant therapy, radiation therapy|
|Sponsor||Case Comprehensive Cancer Center|
|Collaborator||National Cancer Institute (NCI)|
|Start date||June 2000|
|End date||November 2005|
|Trial size||44 participants|
|Trial identifier||NCT00006256, CWRU-2199, CWRU2199, NCI-2010-01058, NCI-G00-1851, P30CA043703|
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining paclitaxel with radiation therapy may kill more tumor cells.
PURPOSE: This trial is to study the effectiveness of concurrent administration of chemotherapy and radiation therapy in treating women who have stage II or stage III breast cancer by examining the complications and cosmetic effects.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Canton, OH||UH-CantonMercy||no longer recruiting|
|Chardon, OH||UH-Geauga||no longer recruiting|
|Cleveland, OH||Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center||no longer recruiting|
|Mayfield Heights, OH||UH-Monarch||no longer recruiting|
|Mentor, OH||UH-LUICC||no longer recruiting|
|Middleburgh Heights, OH||UH-Southwest||no longer recruiting|
|Orange Village, OH||UH-Chagrin Highlands||no longer recruiting|
|South Euclid, OH||UH-Green Road||no longer recruiting|
|Westlake, OH||UH-Westlake||no longer recruiting|
|Intervention model||single group assignment|
Determine the feasibility of concurrent paclitaxel and breast radiotherapy
time frame: Followed every 3 months for 1 year
Cosmetic outcome based upon established descriptive parameters: excellent, good, fair, and poor.
time frame: 1 year
time frame: 1 year
time frame: 5 years
Female participants at least 18 years old.
DISEASE CHARACTERISTICS: - Stage II or III invasive breast cancer - Prior breast conserving surgery (lumpectomy or quadrantectomy) with ipsilateral axillary lymph node dissection required - No prior contralateral breast cancer - No metastatic disease - Prior ductal carcinoma in situ or lobular carcinoma in situ of the breast allowed unless treated with radiation or chemotherapy - Doxorubicin and cyclophosphamide adjuvant chemotherapy completed within past 3 weeks - Candidate for definitive radiotherapy - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age: - 18 and over Sex: - Female Menopausal status: - Not specified Performance status: - ECOG 0-1 Life expectancy: - Not specified Hematopoietic: - WBC at least 3,000/mm3 - Granulocyte count at least 2,000/mm3 - Platelet count at least 100,000/mm3 Hepatic: - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - ALT/AST no greater than 1.5 times ULN Renal: - Creatinine no greater than 1.5 mg/dL Cardiovascular: - No concurrent poorly controlled ischemic heart disease or congestive heart failure - LVEF at least 45% by MUGA scan or echocardiogram Pulmonary: - No concurrent severe chronic obstructive or restrictive pulmonary disease Other: - Not pregnant or nursing - Fertile patients must use effective contraception - No concurrent severe medical or psychiatric illness - No concurrent severe diabetes mellitus - No other prior malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix treated with local excision PRIOR CONCURRENT THERAPY: Biologic therapy: - No concurrent filgrastim (G-CSF) Chemotherapy: - See Disease Characteristics - Prior tamoxifen allowed - No concurrent tamoxifen Endocrine therapy: - Not specified Radiotherapy: - No prior radiation to the breast Surgery: - Recovered form prior surgery Other: - No concurrent adjuvant therapy on another clinical trial
|Official title||Concurrent Taxol (Paclitaxel) and Definitive Breast Radiation Therapy in Early Stage Breast Cancer Following Four Cycles of Adriamycin/Cytoxan Chemotherapy|
|Description||OBJECTIVES: - Determine the feasibility of concurrent paclitaxel and breast radiotherapy in women with stage II or III breast cancer who have had primary breast conserving surgery and adjuvant chemotherapy. - Assess the cosmetic results of breast conservation after this treatment in these patients. - Determine the pulmonary toxicity of this regimen in these patients. OUTLINE: Patients receive paclitaxel IV over 3 hours every 21 days for 4 courses beginning 3 weeks after completion of the last doxorubicin and cyclophosphamide adjuvant regimen. Patients also undergo concurrent radiotherapy 5 days a week for approximately 6-7 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed at 1 month, every 3 months for 1 year, every 6 months for the next 5 years, and then annually thereafter. PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study over 12-18 months.|
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