Head and Neck CancerNCT02666885
Personalised Postoperative Radiochemotherapy in Patients With Head and Neck Cancer
A study testing Integration of PET/MRI in radiotherapy in people with Head and Neck Cancer, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
The current trial is evaluating the integration of a pretherapeutical FDG-PET/MRI in the adjuvant radiochemotherapy in patients with head and neck cancer. As a secondary hypothesis the intention is to develop of a multi-parametric decision support system for personalised medicine by integrating functional imaging… 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?
- Integration of PET/MRI in radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2015to Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- locally-advanced HNSCC (Oro- and Hypopharynx) stage III and IV without distant metastases
- no contraindications for PET/MRI
- no contraindications for radiochemotherapy
- informed consent
- ECOG PS 0/2
Who cannot join
- Secondary malignancies that might influence outcome within 2 years after radiochemotherapy of the HNSCC
- previous PET/CT
- induction therapy
- pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Tübingen, Department of Radiation Oncology
Tübingen, Baden-Wurttemberg, 72076
About this study
Official title: Personalised Postoperative Radiochemotherapy in Patients With Head and Neck Cancer and Development of a Multi-parametric Decision Support System for Personalised Medicine in Radiation Oncology
The current trial is evaluating the integration of a pretherapeutical FDG-PET/MRI in the adjuvant radiochemotherapy in patients with head and neck cancer. As a secondary hypothesis the intention is to develop of a multi-parametric decision support system for personalised medicine by integrating functional imaging, γH2AX-analysis and genetic information.
- Conditions
- Head and Neck Cancer
- Being tested
- Integration of PET/MRI in radiotherapy
- Keywords
- Personalized Medicine, Radiation Oncology, Functional Imaging, Biomarker, Decision Support System, Radiomics
- 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.
Integration of PET/MRI in radiotherapyRadiation
Integration of pretherapeutical PET/MRI in adjuvant radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Integration of PET/MRI in radiotherapy | Experimental | Integration of pretherapeutical PET/MRI in adjuvant radiotherapy Receives: Radiation: Integration of PET/MRI in radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
locoregional progression free survival
15% improvement in loco-regional PFS at 2 years through integrtion of pre-operative PET/MR imaging into RT treatment planning
Measured: 2 years after primary diagnosis
Secondary outcomes (3)
Disease free survival
Measured: 2 years after primary diagnosis
Overall survival
Measured: 2 years after primary diagnosis
Development of a multi-parametric decision support system
Measured: after termination of recruitment and follow up up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study startJul 2015
- Primary completionJun 2019
- Study completionAug 2019
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.
- More trials run by University Hospital TuebingenThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Zips, MD, Prof, Principal investigator, University Hospital Tuebingen, Department of Radiation Oncology, Tuebingen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02666885
- Sponsor's protocol ID
- ZPM_Demonstrator_HNC
- Status last verified
- Feb 2018
- First submitted
- 10 Dec 2015
- Last updated
- 24 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalised Postoperative Radiochemotherapy in Patients With Head and Neck Cancer and Development of a Multi-parametric Decision Support System for Personalised Medicine in Radiation Oncology
- ClinicalTrials.gov ID
- NCT02666885
- Acronym / sponsor ID
- ZPM_Demonstrator_HNC
- Conditions
- Head and Neck Cancer
- Keywords
- Personalized Medicine, Radiation Oncology, Functional Imaging, Biomarker, Decision Support System, Radiomics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 28 Jan 2016 (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 current trial is evaluating the integration of a pretherapeutical FDG-PET/MRI in the adjuvant radiochemotherapy in patients with head and neck cancer. As a secondary hypothesis the intention is to develop of a multi-parametric decision support system for personalised medicine by integrating functional imaging, γH2AX-analysis and genetic information.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Integration of PET/MRI in radiotherapy | Experimental | Radiation: Integration of PET/MRI in radiotherapyIntegration of pretherapeutical PET/MRI in adjuvant radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- locally-advanced HNSCC (Oro- and Hypopharynx) stage III and IV without distant metastases
- no contraindications for PET/MRI
- no contraindications for radiochemotherapy
- informed consent
- ECOG PS 0/2
Key exclusion criteria (4 listed)
- Secondary malignancies that might influence outcome within 2 years after radiochemotherapy of the HNSCC
- previous PET/CT
- induction therapy
- pregnancy or breastfeeding
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 |
|---|---|---|
| Integration of PET/MRI in radiotherapyIntegration of pretherapeutical PET/MRI in adjuvant radiotherapy | Radiation | Integration of PET/MRI in radiotherapy |
Primary outcome
locoregional progression free survival
Time frame: 2 years after primary diagnosis
15% improvement in loco-regional PFS at 2 years through integrtion of pre-operative PET/MR imaging into RT treatment planning
3 secondary outcomes
Disease free survival
Time frame: 2 years after primary diagnosis
Overall survival
Time frame: 2 years after primary diagnosis
Development of a multi-parametric decision support system
Time frame: after termination of recruitment and follow up up to 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2019.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
Daniel Zips, MD, Prof principal investigator
University Hospital Tuebingen, Department of Radiation Oncology, Tuebingen, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integration of PET/MRI in radiotherapy in people with Head and Neck Cancer, run by University Hospital Tuebingen at 1 site in Germany.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 24 Sep 2019. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
locoregional progression free survival (time frame: 2 years after primary diagnosis). 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 24 Sep 2019.