Standard Follow-up Program (SFP) for Head and Neck Cancer Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Radiotherapy (primary or postoperative).
- Who it may be relevant to
- Registry conditions: Head and Neck Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Standard Follow-up Program (SFP) for Head and Neck Cancer Patients Treated With Curative Primary or Postoperative Radiotherapy or Chemoradiation (SFP Head & Neck)
Overview
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
Interventions
- Radiation Radiotherapy (primary or postoperative)
Primary outcome measures
- Late toxicity [Time frame: At 6 months after last day of completion of treatment]
Secondary outcome measures (12)
- 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 [Time frame: At 6,12,18,24,36,48,60 months after completion of treatment]
- Overall survival [Time frame: At 1,2,3,4 and 5 years after completion of treatment]
- Change in locoregional tumour control [Time frame: At 1,2,3,4 and 5 years after completion of treatment]
- Laryngo-oesophageal dysfunction-free survival [Time frame: At 1,2,3,4 and 5 years after completion of treatment]
- 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 [Time frame: At 12 months after last day of completion of treatment]
- Late toxicity [Time frame: At 18 months after last day of completion of treatment]
- Late toxicity [Time frame: At 24 months after last day of completion of treatment]
- Late toxicity [Time frame: At 36 months after last day of completion of treatment]
- Late toxicity [Time frame: At 48 months after last day of completion of treatment]
- Late toxicity [Time frame: At 60 months after last day of completion of treatment]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Netherlands · 1 center
- University Medical Center Groningen — Groningen
Publications
- van der Laan HP, Gawryszuk A, van der Schaaf A, Langendijk JA. Risk reduction of radiation-induced aspiration by sparing specific aspiration-related-organs at risk; an in silico feasibility study. Radiother Oncol. 2025 Feb;203:110698. doi: 10.1016/j.radonc.2024.110698. Epub 2024 Dec 21. PMID 39716592
Identifiers
NCT: NCT02435576 · SFP2007-03