NCT01417286已完成2 期
Accelerated, Hypofractionated Post-Mastectomy Radiation Therapy in Women With Breast Cancer: A Phase II Trial
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 4
- 主要终点
- Number of Participants With Local, Regional, and/or Distant Failure
研究概览
简要总结
This phase II trial studies how well giving accelerated radiation therapy (RT) after surgery works in treating patients with breast cancer. RT uses high energy x rays to kill tumor cells. Giving RT after surgery may kill any remaining tumor cells
详细描述
PRIMARY OBJECTIVES:
I. Freedom from local failure and freedom from regional failure.
SECONDARY OBJECTIVES:
I. Acute toxicity and late toxicity using previously published toxicity scales. II. To identify co-variates responsible for poor cosmetic outcome in women with reconstructed chest walls when treated with accelerated, hypofractionated radiotherapy.
III. To correlate toxicity, cosmesis, and local control with molecular markers.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Invasive ductal, medullary, papillary, colloid (mucinous), or tubular histologies; invasive lobular carcinomas are allowed
- •American Joint Committee for Cancer (AJCC) Stage IIa - IIIc (pathologic stage T0N1-3, T1N1-3, T2N1-3, T3N0-3, T4N0-3, all M0 status) histologically confirmed invasive carcinoma of the breast treated with mastectomy and either sentinel node biopsy or axillary dissection; inflammatory carcinoma (T4d) is allowed
- •Patients with locally advanced breast cancer on clinical exam and diagnostics ( > 3 cm and/or clinically node-positive) who have mastectomy after induction chemotherapy are allowed
- •Multifocal/multicentric disease is allowed
- •Negative inked histologic margins of mastectomy (no invasive cells at margin) or positive margin at pectoralis fascia or skin
- •Tamoxifen, Arimidex or other hormonal therapy is allowed; it may begin any time relative to the radiation at the discretion of the treating physician
- •Chemotherapy is allowed, if chemotherapy is indicated the chemotherapy can be delivered first, followed by radiation therapy beginning 21-63 days after the last cycle of chemotherapy or the radiation therapy can be delivered first and the chemotherapy can be delivered no earlier than 21 days post radiation therapy; neoadjuvant chemotherapy is allowed; radiation therapy will be delivered after mastectomy or after any adjuvant chemotherapy as described above
- •Chest wall reconstruction is allowed
- •The patient must be enrolled and have treatment planning between 14-63 days from date of last surgery or last cycle of chemotherapy, and radiation must start within 21-63 days of date of last surgery or last cycle of chemotherapy
- •Signed study-specific informed consent form prior to study entry
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
排除标准
- •Patient with distant metastases (M1)
- •Patients with ductal or lobular carcinoma in-situ alone (no invasive component) and patients with non-epithelial breast malignancies such as sarcoma or lymphoma
- •Patient with T1N0 or T2N0 disease
- •Prior radiation therapy to the chest
- •Patients with collagen vascular diseases, specifically systemic lupus erythematosus, scleroderma, or dermatomyositis
- •Patients with co-existing medical conditions with life expectancy < 2 years
- •Patients with psychiatric (with the possible exception of incompetence as defined by New Jersey [NJ] law) or addictive disorders that would preclude obtaining informed consent
- •Other malignancy, except non-melanomatous skin cancer, < 5 years prior to participation in this study; the disease-free interval from any prior carcinoma must be continuous
- •Women who are pregnant or lactating due to potential exposure of the fetus to RT and unknown effects of RT to lactating females
- •Women who are able to conceive and unwilling to practice an effective method of birth control; women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to treatment
结局指标
主要结局
Number of Participants With Local, Regional, and/or Distant Failure
时间窗: Up to 5 years after dose of last treatment, an average of 62 months
Assessed by physical examination and other relevant imaging per the discretion of the patients treating physicians. Confirmed by biopsy, and should be coded as either chest wall recurrence, axilla, supraclavicular, or internal mammary.
次要结局
- Count of Participants With Grade Three or Higher Toxicities(weekly during treatment, then two weeks after RT, then at week 8, then every 3-6 months for 3 years, then every 6-12 months out to 5 years.)
- Participants With Plans for Breast Reconstruction, Having Grade Three or Higher Reconstruction Complications(Up to five years after dose of last treatment, an average of 62 months)
研究者
Bruce G Haffty
Professor and Chairman, Department of Radiation Oncology Radiation Oncology
Rutgers, The State University of New Jersey
研究点 (4)
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