Evaluation of Two Boost Radiation Schedules in Post Lumpectomy Early Stage Carcinoma Breast
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Radiation toxicities- acute and early-late
研究概览
简要总结
In a general radiation oncology practice, breast cancer typically comprises approximately 25% of the total patient caseload.1 Surgery is the primary modality of treatment. Radical mastectomy remained the mainstay of surgical therapy into the 1970s. Breast-conserving surgery followed by radiation therapy to the intact breast is an established standard of care for the majority of women with early stage invasive breast cancer. Recommended techniques for breast-conservation treatment are local excision of the primary tumor, preferably with clear margins, axillary lymph node dissection, and breast irradiation (45 to 50 Gy), usually with a boost (10 to 20 Gy, depending on tumor size and status of the surgical margins).
The aim of this study is to compare the two boost regimen 10Gy/5#/1 week with 16Gy/8#/1.5 weeks in post lumpectomy patients of early stage breast cancer, following whole breast irradiation (WBI).
The study will include 50 patients, (25 in each arm) of early stage post lumpectomy breast cancer patients. Each patient will be treated by WBI followed by tumor bed boost with either electron beam therapy or 3D CRT. The primary end point of the study will be assessment of acute and late radiation toxicities, cosmetic score analysis and local control between two schedules. Secondary end points will be recurrence-free survival.
详细描述
Patients to be included in this study will be pre-operatively staged according to American Joint Committee on Cancer (AJCC) 7th edition, International Union against cancer ( which uses TNM staging ) as stage I , stage II of breast carcinoma. Fifty patients of histologically proven post lumpectomy cases of carcinoma breast suitable for whole breast radiotherapy will be enrolled in this study. Patients would be evaluated at the Department of Radiotherapy PGIMER, Chandigarh by doing a thorough clinical examination followed by routine investigations which will include hemogram, liver function tests, kidney function tests, chest X-ray. Patients will be treated by standard rectangular tangential field radiotherapy to whole breast. CT based planning will be done for photons boost and electron beam therapy.
Inclusion criteria
-
Unicentric primary breast cancer with invasive ductal histology. 2. Stage T1, T2, N0, N1, M0 Exclusion criteria
-
Tumor histology with invasive or in situ lobular carcinoma or pure ductal carcinoma in situ.
-
Skin involvement.
-
History of prior primary malignancy.
-
History of prior irradiation to chest
-
Patients who received neoadjuvant chemotherapy. Procedure Fifty patients (25 in each arm) scheduled for whole breast radiotherapy after lumpectomy will be included in this study. An informed written consent in prescribed proforma for all patients will be taken for performing planning CT scan.
Prior to radiotherapy planning, breast conserving surgery in the form of lumpectomy will be carried out in the department of surgery under general anaesthesia. Patients will be recruited 2-3 weeks after lumpectomy. A planning CT scan will be made for each patient. The patients will be positioned on a breast board with sternum parallel to the table, and the ipsilateral arm abducted above the head. Before the CT scan skin marks would be placed to enable the patient repositioning during treatment. Radioopaque markers will be placed to locate the whole breast and lumpectomy cavity on CT images.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Unicentric primary breast cancer with invasive ductal histology.
- •Stage T1, T2, N0, N1, M0 -
排除标准
- •Tumor histology with invasive or in situ lobular carcinoma or pure ductal carcinoma in situ.
- •Skin involvement.
- •History of prior primary malignancy.
- •History of prior irradiation to chest
- •Patients who received neoadjuvant chemotherapy. -
结局指标
主要结局
Radiation toxicities- acute and early-late
时间窗: 6 months
Acute toxicity will be assessed at at 1 month. Assessment of toxicity will be done as per RTOG scores AND LENT SOMA scale Pigmentary change scale: 0 = None 1. = Transitory , slight 2. = Permanent , marked Breast edema: 0 = None 1 = Asymptomatic 2 = Symptomatic 3 = Secondary dysfunction
次要结局
- Cosmetic outcome and local control iii) Local control(6 months to 5 years)
研究者
Dr Budhi Singh Yadav
Assistant Professor
Post Graduate Institute of Medical Education and Research, Chandigarh