Standard Follow-up Program (SFP) for Head and Neck Cancer Patients
- Conditions
- Head and Neck Cancer
- Registration Number
- NCT02435576
- Lead Sponsor
- University Medical Center Groningen
- Brief Summary
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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 10000
- 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.
- All patients planned for palliative radiotherapy will not be included in the SFP.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Late toxicity At 6 months after last day of completion of treatment Late toxicity
- Secondary Outcome Measures
Name Time Method 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 Change in acute toxicity
Late toxicity At 60 months after last day of completion of treatment Late toxicity
Free Thyroxine-4 (FT4) At baseline and at 6, 12, 18, 24, 36, 48 and 60 months after completion of radiation therapy. FT4 levels (pmol/L) measured in blood
Change in locoregional tumour control At 1,2,3,4 and 5 years after completion of treatment Change in locoregional tumour control
Laryngo-oesophageal dysfunction-free survival At 1,2,3,4 and 5 years after completion of treatment Laryngo-oesophageal dysfunction-free survival
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 Change in patient-rated symptoms
Thyroid Stimulating Hormone (TSH) At baseline and at 6, 12, 18, 24, 36, 48 and 60 months after completion of radiation therapy. TSH levels (mU/L) measured in blood
Change in patient-rated quality of life At 6,12,18,24,36,48,60 months after completion of treatment Change in patient-rated quality of life
Overall survival At 1,2,3,4 and 5 years after completion of treatment Overall survival
Trial Locations
- Locations (1)
University Medical Center Groningen
🇳🇱Groningen, Netherlands