An observational study in Head and Neck Cancer, sponsored by Maastricht Radiation Oncology. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Maastricht Radiation Oncology · Observational
The primary and general objective of the clinical introduction of the Standard Follow-up Program (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.
For head and neck squamous cell carcinoma (HNSCC), radiation therapy is one of the mainstays of therapy either as definitive therapy alone or in combination with systemic therapy or following surgical resection as postoperative treatment. Nowadays there's great attention for personalized medicine which aims at offering a patient the treatment that best suits the individual patient and its tumor characteristics. To apply personalized therapy, we need accurate outcome prediction models for disease control, treatment related toxicity and quality of life.
The main factors used for predictive/prognostic nomograms are clinical factors, like patient-, tumor- and treatment related factors (1). Standard examples of these include age, gender, co-morbidity, smoking history, hemoglobin levels, tumor site, TNM stage, tumor volume, HPV-status, and others. For larynx cancer the nomogram was made publicly available on www.predictcancer.org.
However, we anticipate that other factors will contribute to the (improvement of) prediction models. These factors may include genomic analysis of tumor specimens, quantitative image analysis (radiomics), blood biomarkers, and/or tumor-tissue markers (2).
In addition, treatment-related parameters also need to be considered and these not only include factors like overall treatment time, use of systemic therapy, prescribed radiation dose and fraction dose. With new techniques using EPID dosimetry, it is now possible to measure the delivered radiation dose and compare this to the prescribed dose (3,4). This offers the potential to apply Dose Guide RadioTherapy (DGRT), which especially in HNSCC may have a large impact, because anatomical changes during fractionated therapy are known to occur and lead to dose changes to targets and organs at risk (5,6).
The final objective of this study is to integrate all potential prognostic factors and develop reliable nomograms both for tumor control as well as complications.
2,710 studies on the registry are indexed under Head and Neck Neoplasms; 594 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 100 across 502 observational studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →Maastricht Radiation Oncology is the lead sponsor of 106 studies on the registry; 9 are open to participants now.
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Characteristics of the population:
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All patients planned for curatively intended primary or postoperative radiotherapy
Exclusion Criteria:
All patients planned for palliative radiotherapy
Patients with Head and Neck Cancer, treated with curative intent * Any tumor site * Stage I-IV, M0 * Treated with radiotherapy alone or in combination with systemic therapy * Definitive radiotherapy or postoperative radiotherapy Interventions: * Radiation alone * Radiation in combination with systemic therapy
Radiation: Radiation alone · Radiation: Radiation in combination with systemic therapy
Radiation alone
Radiation in combination with systemic therapy
Also known as: Chemoradiation
overall survival
The overall survival will be calculated from the first day of treatment, either the first day of induction chemotherapy or the first day of radiotherapy in case of concomitant chemoradiation or radiation alone. An event is defined as death of any cause.
Time frame: 5 years
disease free survival
Time frame: 5 years
loco-regional control
Loco-regional control will be calculated from the first day of treatment, either the first day of induction chemotherapy or the first day of radiotherapy in case of concomitant chemoradiation or radiation alone. An event is defined as local recurrence and/or regional recurrence. These two events will be separately scored.
Time frame: 5 years
Patient-rated symptoms and quality of life
quality of life (EORTC QLQ-C30, EORTC QLQ-H\&N35, EuroQoL-EQ5D)
Time frame: 5 years
Acute and late toxicity scores, according to CTCv4.0 criteria
Time frame: 5 years
Plan to share: No
No publications or documents are linked to this record.
The record gives a start of Jul 2012, a primary completion of Jan 2030 and a completion of Jan 2030. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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