Standard Follow-up Program (SFP) for Head and Neck Cancer Patients

Study Overview
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Brief Summary
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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
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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

Official Title
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Standard Follow-up Program (SFP) for Head and Neck Cancer Patients Treated With Curative Primary or Postoperative Radiotherapy or Chemoradiation (SFP Head & Neck)

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Radiation: Radiotherapy (primary or postoperative)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: All patients planned for palliative radiotherapy will not be included in the SFP.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: Radiotherapy (primary or postoperative)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late toxicity | Late toxicity | At 6 months after last day of completion of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in acute toxicity | 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 patient-rated quality of life | Change in patient-rated quality of life | At 6,12,18,24,36,48,60 months after completion of treatment | 
| Overall survival | Overall survival | At 1,2,3,4 and 5 years after completion of treatment | 
| Change in locoregional tumour control | Change in locoregional tumour control | At 1,2,3,4 and 5 years after completion of treatment | 
| Laryngo-oesophageal dysfunction-free survival | Laryngo-oesophageal dysfunction-free survival | At 1,2,3,4 and 5 years after completion of treatment | 
| Change in patient-rated symptoms | 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 | 
| Late toxicity | Late toxicity | At 12 months after last day of completion of treatment | 
| Late toxicity | Late toxicity | At 18 months after last day of completion of treatment | 
| Late toxicity | Late toxicity | At 24 months after last day of completion of treatment | 
| Late toxicity | Late toxicity | At 36 months after last day of completion of treatment | 
| Late toxicity | Late toxicity | At 48 months after last day of completion of treatment | 
| Late toxicity | Late toxicity | At 60 months after last day of completion of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute toxicity, Late toxicity, NTCP models, Proton therapy, Patient-rated outcomes, Quality of life