A COMPARATIVE STUDY EVALUATING ACUTE TOXICITY AND BREASTCOSMESIS IN EARLY STAGE BREAST CANCER PATIENTS RECEIVINGMODERATE VERSUS EXTREME HYPOFRACTIONATED RADIOTHERAPY
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- To compare acute toxicity in breast carcinoma patients treated with moderately Hypofractionated radiotherapy versus extreme hypofractionated radiotherapy.
研究概览
简要总结
A COMPARATIVE STUDY EVALUATING ACUTE TOXICITY AND BREAST COSMESIS IN EARLY STAGE BREAST CANCER PATIENTS RECEIVING MODERATE VERSUS EXTREME HYPOFRACTIONATED RADIOTHERAPY- Breast cancer is treated with surgery, chemotherapy, radiotherapy and hormonal agents. The techniques of radiotherapy available are varied and so are the dose schedules, with more than one standard dose schedules. In this study, we are comparing two standard radiation dose schedules. The 1st one treatment completes in 4 weeks and in the 2nd one treatment completes in 2 weeks. Both of them has been found to be similar in efficacy and toxicity in early stage breast cancer patients of western countries. We plan to evaluate the radiation schedules in terms of the acute toxicity and the breast cosmesis in our Indian population. We believe this study would enable us to take a more informed decision on the choice of dose schedule for the patients with early breast cancer in India.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- Female
入选标准
- •Histologically proven invasive carcinoma of the breast cT1-T2 N0-1M0 and cT3N0 AJCC stage 1 & 2 patients following complete excision of the primary tumour by breast conservation surgery. There should be adequate surgical resection of primary (ink negative) and nodal disease (negative sentinel lymph node biopsy or adequate axillary sampling or dissection (yield atleast 10 nodes).
- •Written informed consent
- •18 to 70 years
- •Female gender
- •ECOG Performance status
- •Non-metastatic disease.
排除标准
- •Any histopathology other than invasive carcinoma and DCIS.
- •Synchronous or metachronous malignancy.
- •Pregnant or lactating women.
- •Uncontrolled concurrent illness like DM, HTN, tuberculosis.
- •Evidence of distant metastasis.
- •Recurrent or residual disease.
- •Previous history of radiation to thoracic and neck area.
- •Patients not meeting dose volume constraints.
结局指标
主要结局
To compare acute toxicity in breast carcinoma patients treated with moderately Hypofractionated radiotherapy versus extreme hypofractionated radiotherapy.
时间窗: Weekly assessment of acute toxicity during radiotherapy at 4 weeks & 3 months
次要结局
- -To compare breast cosmesis in breast carcinoma patients treated with moderately hypofractionated radiotherapy versus extreme hypofractionated radiotherapy.(-Skin changes & subcutaneous tissue changes)