Head and Neck CancerH&NTOXNCT02435576
Standard Follow-up Program (SFP) for Head and Neck Cancer Patients
An observational study of Head and Neck Cancer, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
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… 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?
- Radiotherapy (primary or postoperative)
- Type of treatment
- Surgery or procedure
- How many people
- 10,000 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2007to Jan 2028
- 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: All patients with head and neck cancer planned for curatively intended primary or postoperative radiotherapy will be included.
Who may be able to join
- 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.
Who cannot join
- All patients planned for palliative radiotherapy will not be included in the SFP.
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
University Medical Center Groningen
Groningen, 9700RB
J.A. Langendijk, Prof. Dr., +31503615532, j.a.langendijk@umcg.nl
J.A. Langendijk, Prof. Dr.
About this study
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)
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.
Read the 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
- Conditions
- Head and Neck Cancer
- Being tested
- Radiotherapy (primary or postoperative)
- Keywords
- Acute toxicity, Late toxicity, NTCP models, Proton therapy, Patient-rated outcomes, Quality of life
- 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.
Radiotherapy (primary or postoperative)Radiation
What is being measured
The primary outcome is the main question the study is designed to answer.
Late toxicity
Late toxicity
Measured: At 6 months after last day of completion of treatment
Secondary outcomes (14)
Change in acute toxicity
Change in acute toxicity
Measured: 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
Measured: At 6,12,18,24,36,48,60 months after completion of treatment
Overall survival
Overall survival
Measured: At 1,2,3,4 and 5 years after completion of treatment
Change in locoregional tumour control
Change in locoregional tumour control
Measured: At 1,2,3,4 and 5 years after completion of treatment
Laryngo-oesophageal dysfunction-free survival
Laryngo-oesophageal dysfunction-free survival
Measured: At 1,2,3,4 and 5 years after completion of treatment
Change in patient-rated symptoms
Change in patient-rated symptoms
Measured: 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
Measured: At 12 months after last day of completion of treatment
Late toxicity
Late toxicity
Measured: At 18 months after last day of completion of treatment
Late toxicity
Late toxicity
Measured: At 24 months after last day of completion of treatment
Late toxicity
Late toxicity
Measured: At 36 months after last day of completion of treatment
Late toxicity
Late toxicity
Measured: At 48 months after last day of completion of treatment
Late toxicity
Late toxicity
Measured: At 60 months after last day of completion of treatment
Thyroid Stimulating Hormone (TSH)
TSH levels (mU/L) measured in blood
Measured: At baseline and at 6, 12, 18, 24, 36, 48 and 60 months after completion of radiation therapy.
Free Thyroxine-4 (FT4)
FT4 levels (pmol/L) measured in blood
Measured: At baseline and at 6, 12, 18, 24, 36, 48 and 60 months after completion of radiation therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study startMar 2007
- Primary completionJan 2025 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- 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
- 10,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- J.A. Langendijk, Prof. Dr., Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02435576
- Sponsor's protocol ID
- SFP2007-03
- Acronym
- H&NTOX
- Status last verified
- Apr 2024
- First submitted
- 27 Mar 2015
- Last updated
- 15 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 39716592
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02435576
- Acronym / sponsor ID
- H&NTOX / SFP2007-03
- Conditions
- Head and Neck Cancer
- Keywords
- Acute toxicity, Late toxicity, NTCP models, Proton therapy, Patient-rated outcomes, Quality of life
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 6 May 2015 (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 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with head and neck cancer planned for curatively intended primary or postoperative radiotherapy will be included.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- All patients planned for palliative radiotherapy will not be included in the SFP.
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 |
|---|---|---|
| Radiotherapy (primary or postoperative) | Radiation | – |
Primary outcome
Late toxicity
Time frame: At 6 months after last day of completion of treatment
Late toxicity
14 secondary outcomes
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
Thyroid Stimulating Hormone (TSH)
Time frame: At baseline and at 6, 12, 18, 24, 36, 48 and 60 months after completion of radiation therapy.
Free Thyroxine-4 (FT4)
Time frame: At baseline and at 6, 12, 18, 24, 36, 48 and 60 months after completion of radiation therapy.
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 15 Apr 2024.
- Derived from this study: PubMed 39716592van 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.
- 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.
J.A. Langendijk, Prof. Dr. principal investigator
University Medical Center Groningen
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 University Medical Center Groningen 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 15 Apr 2024. 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 J.A. Langendijk, Prof. Dr. (+31503615532, j.a.langendijk@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Late toxicity (time frame: At 6 months after last day of completion of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02435576, which also lists 1 linked publication.
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 15 Apr 2024.