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Concurrent Taxol (Paclitaxel) and Definitive Breast Radiation Therapy in Early Stage Breast Cancer Following Four Cycles of Adriamycin/Cytoxan Chemotherapy
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.
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.
Age
18 - 120 years
Sex
FEMALE
Healthy Volunteers
No
UH-CantonMercy
Canton, Ohio, United States
UH-Geauga
Chardon, Ohio, United States
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
UH-Monarch
Mayfield Heights, Ohio, United States
UH-LUICC
Mentor, Ohio, United States
UH-Southwest
Middleburg Heights, Ohio, United States
UH-Chagrin Highlands
Orange, Ohio, United States
UH-Green Road
South Euclid, Ohio, United States
UH-Westlake
Westlake, Ohio, United States
Start Date
June 8, 2000
Primary Completion Date
November 30, 2005
Completion Date
November 20, 2023
Last Updated
November 30, 2023
44
ACTUAL participants
paclitaxel
DRUG
adjuvant therapy
PROCEDURE
radiation therapy
RADIATION
Lead Sponsor
Case Comprehensive Cancer Center
NCT05245812
NCT05673200
Data Source & Attribution
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