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.
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
Study Type
OBSERVATIONAL
Enrollment
10,000
University Medical Center Groningen
Groningen, Netherlands
RECRUITINGLate toxicity
Late toxicity
Time frame: At 6 months after last day of completion of treatment
Change in acute toxicity
Change in acute toxicity
Time frame: 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 quality of life
Change in patient-rated quality of life
Time frame: At 6,12,18,24,36,48,60 months after completion of treatment
Overall survival
Overall survival
Time frame: At 1,2,3,4 and 5 years after completion of treatment
Change in locoregional tumour control
Change in locoregional tumour control
Time frame: At 1,2,3,4 and 5 years after completion of treatment
Laryngo-oesophageal dysfunction-free survival
Laryngo-oesophageal dysfunction-free survival
Time frame: At 1,2,3,4 and 5 years after completion of treatment
Change in patient-rated symptoms
Change in patient-rated symptoms
Time frame: 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
Late toxicity
Time frame: At 12 months after last day of completion of treatment
Late toxicity
Late toxicity
Time frame: At 18 months after last day of completion of treatment
Late toxicity
Late toxicity
Time frame: At 24 months after last day of completion of treatment
Late toxicity
Late toxicity
Time frame: At 36 months after last day of completion of treatment
Late toxicity
Late toxicity
Time frame: At 48 months after last day of completion of treatment
Late toxicity
Late toxicity
Time frame: At 60 months after last day of completion of treatment
Thyroid Stimulating Hormone (TSH)
TSH levels (mU/L) measured in blood
Time frame: At baseline and at 6, 12, 18, 24, 36, 48 and 60 months after completion of radiation therapy.
Free Thyroxine-4 (FT4)
FT4 levels (pmol/L) measured in blood
Time frame: At baseline and at 6, 12, 18, 24, 36, 48 and 60 months after completion of radiation therapy.
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