Concurrent Taxol (Paclitaxel) and Definitive Breast Radiation Therapy in Early Stage Breast Cancer Following Four Cycles of Adriamycin/Cytoxan Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 9
- 主要终点
- Determine the feasibility of concurrent paclitaxel and breast radiotherapy
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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:
- •18 and over
- •Menopausal status:
- •Not specified
- •Performance status:
- •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
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •ALT/AST no greater than 1.5 times ULN
- •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
- •No concurrent severe chronic obstructive or restrictive pulmonary disease
- •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
- •Recovered form prior surgery
- •No concurrent adjuvant therapy on another clinical trial
排除标准
- 未提供
结局指标
主要结局
Determine the feasibility of concurrent paclitaxel and breast radiotherapy
时间窗: Followed every 3 months for 1 year
Ability to deliver appropriate doses of radiation therapy within the appropriate time course
chemotherapy dose achieved during concurrent Taxol and radiation therapy.
时间窗: Followed every 3 months for 1 year
次要结局
- Cosmetic outcome based upon established descriptive parameters: excellent, good, fair, and poor.(1 year)
- Survival(5 years)
- Pulmonary function(1 year)