A Phase III Randomized Study Comparing Two Adjuvant Hypofractionated Radiation Schedules in Patients With Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,070
- 试验地点
- 2
- 主要终点
- Local Recurrence
研究概览
简要总结
The investigators at PGIMER have been practicing hypofractionation radiotherapy with a dose of 35Gy/15#/3wks to the chest wall in post mastectomy and 40Gy/16#/3wks in breast conservation in breast cancer patients for the last 4 decades. It is also a routine practice in UK and few centers in Canada. Hypofractionation reduces treatment time to half while maintaining cosmesis and gives control rates equal to conventional fractionation. As breast cancer is a leading cancer in females and radiation therapy is an important part of its local management, hypofractionation help the radiation centers worldwide to meet the growing need for radiation in breast cancer, particularly in developing countries where resources are limited. It also reduces the financial burden on the patient and family. In this study the investigators want to reduce the treatment duration from 3 weeks to 2 weeks. The study will include 1000 patients, 500 in each arm, with breast cancer post mastectomy or after breast conservative surgery to be treated with a radiotherapy dose of 34Gy in 10 fractions over 2 weeks in the study arm and 35Gy in 15 fractions over 3 weeks in the control arm. The primary endpoint of the study will be ipsilateral local tumour control. Secondary endpoints will be early and late adverse effects in normal tissues, quality of life, contralateral primary tumours, regional and distant metastases and 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-III of breast carcinoma. Total 500 patients of histologically proven post lumpectomy/mastectomy cases of carcinoma breast suitable for 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 fields.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Invasive carcinoma of the breast
- •Breast conservation surgery or mastectomy
- •Axillary staging &/or dissection
- •Complete microscopic excision of primary tumour
- •pT1-3 pN0-2 M0 disease
- •Written informed consent
- •Able to comply with follow up
排除标准
- •Past history of malignancy except (i) basal cell skin cancer and CIN cervix uteri or (ii) non-breast malignancy allowed if treated with curative intent and at least 5 years disease free
- •Contralateral breast cancer, including DCIS, irrespective of date of diagnosis
- •Breast reconstruction using implants
- •Concurrent cytotoxic chemotherapy (sequential neoadjuvant or adjuvant cytotoxic therapy allowed)
结局指标
主要结局
Local Recurrence
时间窗: 5 years
Any recurrence with in the irradiated area from completion of radiation
次要结局
- Acute skin toxicity(After 1 month of completion of radiation)
- Cosmetic assessment(Baseline, 1 year, 3 years, 5 years)
- Disease free survival(5 years, 10 years)
- Overall survival(5 years, 10 years)
- Arm edema(3 years, 5 years, 10 years)
- Late effects- pain, shoulder stiffness(3 years, 5 years, 10 years)
- Late effects- Brachial plexopathy(3 years, 5 years, 10 years)
- Late effects- Lung, cardiac(5 years, 10 years)
- Quality of life(3 year, 5 year)
研究者
Dr Budhi Singh Yadav
Additional Professor
Post Graduate Institute of Medical Education and Research, Chandigarh