Standard Follow-up Program (SFP) for Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Score of Acute toxicity
研究概览
简要总结
Motive:
In order to improve the treatment technique, a comprehensive follow-up program is needed to obtain all relevant patient, treatment and toxicity data from breast cancer patients.
Goal:to set-up and maintain a database containing treatment results in terms of tumor control, side effects, complications and patient-reported quality of life.
A standard database of patiënts receiving photon treatment will be created. These data are then linked to dose-volume data of radiotherapy, with the aim to build prediction models for both tumor control and toxicity after radio (chemo) therapy that can later be used for selecting patients for proton treatment.
To set-up and maintain a database containing treatment results in terms of tumor control, side effects, complications and patient-reported quality of life.
A standard database of patients receiving photon treatment will be created. These data are then linked to dose-volume data of radiotherapy, with the aim to build prediction models for both tumor control and toxicity after radio (chemo) therapy that can later be used for selecting patients for proton treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with breast cancer Patients receiving a radiotherapy dose
排除标准
- •Failure to comply with any of the inclusion criteria
结局指标
主要结局
Score of Acute toxicity
时间窗: Before start of radiation therapy and during radiation therapy and at 2 weeks after last day of radiation therapy.
Acute Toxicity is measured with Common Terminology Criteria for Adverse Events (CTCAE).
Score of Late toxicity
时间窗: At one and two years after last day of radiation therapy.
Late Toxicity is measured with Common Terminology Criteria for Adverse Events (CTCAE).
次要结局
- Overall survival(At 2 weeks after last day of radiation therapy and thereafter yearly, anticipated average 5-10 years.)
- Loco-regional tumor control(At 2 weeks after last day of radiation therapy and thereafter yearly, anticipated average 5-10 years.)