Head and Neck CancerOutcomeH&NNCT01985984
Outcome Prediction in Head&Neck Cancer Patients After Radiotherapy
An observational study of Head and Neck Cancer, run by Maastricht Radiation Oncology at 1 site in Netherlands.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Radiation alone and Radiation in combination with systemic therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2012to Jan 2030
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Characteristics of the population: * 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
Who may be able to join
- All patients planned for curatively intended primary or postoperative radiotherapy
Who cannot join
- All patients planned for palliative radiotherapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Maastro Clinic
Maastricht
Ph Lambin, prof Dr
Frank Hoebers, Dr.
About this study
Official title: Outcome Prediction in Head&Neck Cancer Patients After Radiotherapy Using Multi-parameter Modelling: Disease Control, Toxicity and Quality of Life
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.
Read the detailed description
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.
- Conditions
- Head and Neck Cancer
- Being tested
- Radiation alone, Radiation in combination with systemic therapy
- Keywords
- Head and neck cancer
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation aloneRadiation
Radiation alone
Radiation in combination with systemic therapyRadiation
Also called Chemoradiation
Radiation in combination with systemic therapy
| Study group | Role | What they receive |
|---|---|---|
| H&N cancer patients | 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 Receives: Radiation: Radiation alone; Radiation: Radiation in combination with systemic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (2)
disease free survival
Measured: 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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2013 (estimated)
- Study startJul 2012
- Primary completionJan 2030 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Maastricht Radiation Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- F Hoebers, MD, PhD, Principal investigator, Maastro Clinic, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01985984
- Sponsor's protocol ID
- 12-02-8/02-extern-6820
- Acronym
- OutcomeH&N
- Status last verified
- Oct 2026
- First submitted
- 11 Nov 2013
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome Prediction in Head&Neck Cancer Patients After Radiotherapy Using Multi-parameter Modelling: Disease Control, Toxicity and Quality of Life
- ClinicalTrials.gov ID
- NCT01985984
- Acronym / sponsor ID
- OutcomeH&N / 12-02-8/02-extern-6820
- Conditions
- Head and Neck Cancer
- Keywords
- Head and neck cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Maastricht Radiation OncologyUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 18 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| H&N cancer patients | – | Radiation: Radiation alone, Radiation: Radiation in combination with systemic therapyPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Characteristics of the population: * 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
Key inclusion criteria (1 listed)
- All patients planned for curatively intended primary or postoperative radiotherapy
Key exclusion criteria (1 listed)
- All patients planned for palliative radiotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiation aloneRadiation alone | Radiation | H&N cancer patients |
| Radiation in combination with systemic therapyAlso: ChemoradiationRadiation in combination with systemic therapy | Radiation | H&N cancer patients |
Primary outcome
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.
2 secondary outcomes
disease free survival
Time frame: 5 years
loco-regional control
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
F Hoebers, MD, PhD principal investigator
Maastro Clinic, The Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer, run by Maastricht Radiation Oncology at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact F Hoebers, MD, PhD (+31884455600, frank.hoebers@maastro.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.