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NCT Number: NCT01985984

Outcome Prediction in Head&Neck Cancer Patients After Radiotherapy

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.

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Maastro Clinic

Maastricht, Netherlands

Location status: Recruiting

Location contact

Frank Hoebers, Dr.

PRINCIPAL_INVESTIGATOR

Ph Lambin, prof Dr

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All patients planned for curatively intended primary or postoperative radiotherapy

Exclusion criteria

All patients planned for palliative radiotherapy

Treatment and study plan

Radiation alone

Radiation

Radiation alone

Radiation in combination with systemic therapy

Radiation

Radiation in combination with systemic therapy

Other names: Chemoradiation

Primary outcomes

  1. overall survival

    Time frame: 5 years

    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.

Secondary outcomes

  1. disease free survival

    Time frame: 5 years

  2. loco-regional control

    Time frame: 5 years

    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.

Other outcomes

  1. Patient-rated symptoms and quality of life

    Time frame: 5 years

    quality of life (EORTC QLQ-C30, EORTC QLQ-H&N35, EuroQoL-EQ5D)

  2. Acute and late toxicity scores, according to CTCv4.0 criteria

    Time frame: 5 years

Study contacts

Contact information is provided by the study sponsor or research team.

F Hoebers, MD, PhD

CONTACT

[email protected]

+31884455666

Sponsors and collaborators

Lead sponsor

Maastricht Radiation Oncology

Other

Registry information

Official study title

Outcome Prediction in Head&Neck Cancer Patients After Radiotherapy Using Multi-parameter Modelling: Disease Control, Toxicity and Quality of Life

Acronym: OutcomeH&N

Important dates

Study start
2012
Primary completion
2030
Study completion
2030
First posted
Nov 18, 2013
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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