Hypofractionated Radiotherapy Schedule of 35 Gray in 10 Fractions in Advanced Incurable Breast Cancer: A Prospective Phase I/II Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Proportion of patients with CTCAE 4.03 defined Grade 3 or more toxicity
研究概览
简要总结
This prospective phase I/II study to assess the clinical toxicity and investigate the clinical response of breast cancers to a 10 fraction hypofractionated course of radiation therapy in advanced incurable breast cancer patients. This study would also investigate the feasibility of voluntary breath hold technique for heart sparing in left sided breast cancer patients. An intervention radiation therapy dose of 35 Gray in 10 fractions over 2 weeks, 5 fractions per week, 1 fraction per day will be studied within this clinical trial. Primary objective of the study is to assess the toxicity using CTCAE version 4 and LENTSOMA toxicity criteria, in advanced incurable breast cancer patients treated with hypofractionated radiotherapy schedule of 35 GY in 10 fractions . Secondary objectives are 1. response rate after radiotherapy measured using the PERCIST criteria at 3 months. 2. Change in quality of life measured using trial outcome index (TOI) at 2 weeks after radiotherapy. 3. Measure the change in PHQ4 score at 2 weeks after radiotherapy.
Additionally to assess the feasibility of voluntary breath hold technique for heart sparing in left sided breast cancer patients and to biobank tissue and blood for future radiobiology tests. A total of 30 patients will be recruited in this study. Among these 30 patients at least 10 patients will be recruited with left sided breast cancer on which feasibility of voluntary breath hold technique for heart sparing will be tested. Patient will be followed up weekly during radiotherapy, then monthly for 1st three months, then 3 monthly for two years, then 6 monthly for next 3 years.
详细描述
Study design: Prospective interventional phase I/II study Study area: Tata Medical Center, Kolkata
Aims and objectives:
Primary objective To assess the toxicity using CTCAE version 4 and LENTSOMA toxicity criteria, in advanced incurable breast cancer patients treated with hypofractionated radiotherapy schedule of 35 GY in 10 fractions Secondary objectives
- response rate after radiotherapy measured using the PERCIST criteria at 3 months. 2. Change in quality of life measured using trial outcome index (TOI) at 2 weeks after radiotherapy. 3. Measure the change in PHQ4 score at 2 weeks after radiotherapy.
To assess the impact of hypofractionated breast radiotherapy schedule of 35 GY in 10 fractions over 2 weeks on quality of life in advanced incurable breast cancer patients using FACT B scores PHQ4 questionnaire
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
- •(all of 1-4)
- •1.Invasive carcinoma of the breast 2.ECOG performance Status:0,I,II 3a.Locally Advanced breast cancer which is not amenable to curative surgery as decided by Multidisciplinary tumor board OR 3b.Metastatic breast cancer patients: i) who are awaiting palliative locoregional radiotherapy for symptom (pain,bleeding,ulceration) ii) who have completed a scheduled course of palliative chemotherapy and is felt to benefit from local radiation therapy 4.Able to give consent
排除标准
- •Breast reconstruction using implants
- •Concurrent cyto-toxic chemotherapy -
结局指标
主要结局
Proportion of patients with CTCAE 4.03 defined Grade 3 or more toxicity
时间窗: 2 Years
The proportion of patients with CTCAE 4.03 defined Grade 3 or more toxicity related to radiotherapy will be assesed. This will include toxicities like radiation fibrosis, lymphedema, pneumonitis and brachial plexopathy.
次要结局
未报告次要终点