Standard Follow-up Program (SFP) for Head and Neck Cancer Patients Treated With Curative Primary or Postoperative Radiotherapy or Chemoradiation (SFP Head & Neck)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Late toxicity
研究概览
简要总结
The primary and general objective of the clinical introduction of the SFP as the current standard of care is to improve the quality of radiotherapy for head and neck cancer patients by reducing radiation-induced side effects without hampering treatment efficacy in terms of locoregional tumour control and overall survival and to systematically evaluate the beneficial effect of newly introduced radiation technology for this particular group of patients. The clinical introduction of the SFP will allow for a systematic and broad scale quality improvement cycle for head and neck cancer patients treated with radiotherapy. In fact, this methodology can be considered a kind of quality circle for the clinical introduction of new radiation techniques, aiming at continuous efforts for further improvement.
详细描述
Specific objectives
- To develop, validate, and improve normal tissue complication probability (NTCP) models for a wide variety of acute and late radiation-induced side effects relevant for head and neck cancer patients (step 1);
- To use the outcome of the NTCP models to better inform patients on the risks on acute and late toxicity;
- To use the outcome of the NTCP models for the definition of dose constraints for radiotherapy treatment planning in current practice;
- To use the outcome of the NTCP models for the development and investigation of the potential benefit of new and emerging radiation delivery technique, such as swallowing sparing intensity modulation radiation therapy (IMRT) and proton radiotherapy.
- To compare the outcome of new radiation delivery techniques that are clinically introduced with the current standard in terms of radiation-induced toxicity, patient-rated symptoms and quality of life and in terms of locoregional tumour control and overall survival
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients planned for curatively intended primary or postoperative radiotherapy will be included. At the first visit, patients are informed about the standard follow up program by the treating physician.
排除标准
- •All patients planned for palliative radiotherapy will not be included in the SFP.
结局指标
主要结局
Late toxicity
时间窗: At 6 months after last day of completion of treatment
Late toxicity
次要结局
- Change in acute toxicity(At 1,2,3,4,5,6,7 (= during radiation therapy) and 12 weeks (= 6 weeks after completion of treatment) after first day of radiation therapy)
- Late toxicity(At 60 months after last day of completion of treatment)
- Free Thyroxine-4 (FT4)(At baseline and at 6, 12, 18, 24, 36, 48 and 60 months after completion of radiation therapy.)
- Change in locoregional tumour control(At 1,2,3,4 and 5 years after completion of treatment)
- Laryngo-oesophageal dysfunction-free survival(At 1,2,3,4 and 5 years after completion of treatment)
- Change in patient-rated symptoms(At 1,2,3,4,5,6,7 (= during radiation therapy) and 12 weeks (= 6 weeks after completion of treatment) after first day of radiation therapy)
- Thyroid Stimulating Hormone (TSH)(At baseline and at 6, 12, 18, 24, 36, 48 and 60 months after completion of radiation therapy.)
- Change in patient-rated quality of life(At 6,12,18,24,36,48,60 months after completion of treatment)
- Overall survival(At 1,2,3,4 and 5 years after completion of treatment)