Radiation Therapy Plus Paclitaxel in Treating Patients With Stage IIB or Stage III Breast Cancer
Weekly Paclitaxel During Radiation Therapy for Locally Advanced Breat Cancer
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of radiation therapy plus paclitaxel in treating patients with stage IIB or stage III breast cancer.
研究概览
详细说明
OBJECTIVES: I. Evaluate the safety and feasibility of twice a week paclitaxel and radiation therapy in patients with locally advanced breast cancer. II. Determine the pathological effects of paclitaxel and radiation in locally advanced breast cancer.
OUTLINE: This is a nonrandomized, dual institution study. Patients receive paclitaxel IV over 1 hour twice a week for a total of 8 weeks. This is started within 1 week of a tumor biopsy. Patients receive radiotherapy 5 days/week for 5.0 weeks within 1 week of the first paclitaxel dose. Operable patients who have progressive disease with the above therapy undergo a modified radical mastectomy (MRM), then receive 4 courses of doxorubicin IV and cyclophosphamide IV, administered once every 21 days. Inoperable patients receive this same chemotherapy regimen, then are reevaluated for surgery. Patients who have stable disease or who respond to the paclitaxel/radiation regimen undergo a MRM, then receive 4 courses of doxorubicin IV and paclitaxel IV (over 3 hours) once every 21 days. All patients with hormone receptor positive tumors receive tamoxifen for 5 years after all other therapy is completed.
PROJECTED ACCRUAL: A total of 40 patients (20 patients per institution) will be accrued over 18- 24 months.
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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California
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Los Angeles、California、美国、90033-0800
- USC/Norris Comprehensive Cancer Center
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Florida
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Jacksonville、Florida、美国、32224
- Mayo Clinic Jacksonville
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
DISEASE CHARACTERISTICS: Histologically proven, untreated, locally advanced breast cancer; stage IIB (T3 N0), IIIA, or IIIB Measurable disease Not inflammatory breast cancer or other stage IIB (T2 N1) No distant metastases except for positive ipsilateral supraclavicular nodes
PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant Fertile patients must use effective contraception during and 6 months after treatment Medically and psychologically stable
PRIOR CONCURRENT THERAPY: No prior therapy of any type
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
合作者和调查者
调查人员
- 学习椅:Darcy V. Spicer, MD、University of Southern California
出版物和有用的链接
一般刊物
- Adams S, Chakravarthy AB, Donach M, Spicer D, Lymberis S, Singh B, Bauer JA, Hochman T, Goldberg JD, Muggia F, Schneider RJ, Pietenpol JA, Formenti SC. Preoperative concurrent paclitaxel-radiation in locally advanced breast cancer: pathologic response correlates with five-year overall survival. Breast Cancer Res Treat. 2010 Dec;124(3):723-32. doi: 10.1007/s10549-010-1181-8. Epub 2010 Sep 29.
- Formenti SC, Volm M, Skinner KA, Spicer D, Cohen D, Perez E, Bettini AC, Groshen S, Gee C, Florentine B, Press M, Danenberg P, Muggia F. Preoperative twice-weekly paclitaxel with concurrent radiation therapy followed by surgery and postoperative doxorubicin-based chemotherapy in locally advanced breast cancer: a phase I/II trial. J Clin Oncol. 2003 Mar 1;21(5):864-70. doi: 10.1200/JCO.2003.06.132.
- Formenti SC, Symmans WF, Volm M, Skinner K, Cohen D, Spicer D, Danenberg PV. Concurrent paclitaxel and radiation therapy for breast cancer. Semin Radiat Oncol. 1999 Apr;9(2 Suppl 1):34-42.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- CDR0000065692 (1B-97-2)
- LAC-USC-1B972
- NCI-G97-1304
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