Head and Neck CancerHNprädBioNCT02059668
Observational Study on Biomarkers in Head and Neck Cancer (HNprädBio)
An observational study of Head and Neck Cancer, run by Technische Universität Dresden at 10 sites in Germany.
Trial summary
The aim of this clinical research project is to validate the prognostic impact of potential biomarkers on loco-regional control of locally advanced head and neck cancer after definitive or adjuvant radiochemotherapy. The treatment is equal to the standard of care. 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?
- Biomarker analyses head & neck cancer tissue, blood specimen
- How many people
- 588 participants
- Where
- 10 sitesGermany
- Study dates
- Mar 2014to Jun 2022
- Phase
- Observational
- 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
Study population: Patients with the diagnosis locally advanced squamous cell carcinoma of the head and neck area
Who may be able to join
- Primary radiochemotherapy:
- Patients with locally advanced squamous cell carcinoma of the oral cavity, oropharynx or hypopharynx
- Stage III or IV without distant metastases
- Patient is able to participate in regular tumor follow-up care
- planned irradiation dose 69-72 Gy
- planned overall treatment time 38-54 days
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- written informed consent of the patient
- general condition according to WHO 0-2
- planned simultaneous chemotherapy with cisplatin (cumulative planned total dose minimum 180 mg/m2 body surface, divided in several separately doses)
- Adjuvant radiochemotherapy:
- Patients with locally advanced squamous cell carcinoma of the oral cavity, oropharynx or hypopharynx
- surgery, existence of one or more of the following risk factors for local recurrence:
- extracapsular growth of a minimum of one lymph node metastasis
- R1 resection
- pT4 tumor and more than 3 affected lymph nodes
- Patient is able to participate in regular tumor follow-up care
- planned irradiation dose 63-66 Gy
- planned overall treatment time 44-48 days
- planned simultaneous chemotherapy with cisplatin (cumulative planned total dose minimum 200 mg/m2 body surface, divided in several separately doses)
- written informed consent of the patient
- general condition according to WHO 0-2
- time since last surgery <56 days (8 weeks)
Who cannot join
- Primary radiochemotherapy:
- distant metastasis
- contraindication against a cisplatin-based chemotherapy
- planned total irradiation dose <69 Gy and >72 Gy
- planned overall treatment time >54 days or <38 days
- Patient is incapable of giving consent
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- previous radiotherapy in the head and neck area, if there is a risk for overlapping of the irradiation areas
- other tumor diseases, which currently need a treatment or probably within the next two years or which influence the prognosis of the patient
- tumor-independent diseases or conditions which reduce the survival probability of the patient to <2 years or which affect the follow-up over 2 years
- no written informed consent
- induction chemotherapy
- pregnancy or lactation
- Adjuvant radiochemotherapy:
- distant metastasis
- contraindication against a cisplatin-based chemotherapy
- planned total irradiation dose < 63 Gy or > 66 Gy
- planned overall treatment time > 48 days or < 44 day
- Patient is incapable of giving consent
- previous radiotherapy in the head and neck area, if there is a risk for overlapping of the irradiation areas
- other tumor diseases, which currently need a treatment or probably within the next two years or which influence the prognosis of the patient
- tumor-independent diseases or conditions which reduce the survival probability of the patient to <2 years or which affect the follow-up over 2 years
- no written informed consent
- pregnancy or lactation
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Germany10 sites
Prof. Volker Budach
Berlin, 10117
Prof. Mechthild Krause
Dresden, Saxony, 01307
Praxis für Strahlentherapie im Krankenhaus Dresden - Friedrichstadt
Dresden, 01067
Prof. Martin Stuschke
Essen, North Rhine-Westphalia, 45147
Prof. Claus Rödel
Frankfurt am Main, Hesse, 60590
Prof. Anca-Ligia Grosu
Freiburg im Breisgau, Baden-Wurttemberg, 79106
Prof. Jürgen Debus
Heidelberg, Baden-Wurttemberg, 69120
Prof. Claus Belka
München, Bavaria, 81377
Prof. Stephanie Combs
München, Bavaria, 81675
Prof. Daniel Zips
Tübingen, Baden-Wurttemberg, 72016
About this study
Official title: Observational Study on Biomarkers in Head and Neck Cancer
The aim of this clinical research project is to validate the prognostic impact of potential biomarkers on loco-regional control of locally advanced head and neck cancer after definitive or adjuvant radiochemotherapy. The treatment is equal to the standard of care.
Potential biomarkers from a previous retrospective study will be validated in this prospective study.
Read the detailed description
Objectives:
Primary: Evaluation of local-regional recurrence- free survival after two years of patients with locally advanced head and neck cancer who received definitive or adjuvant radiochemotherapy.
Secondary: Evaluation of disease-free -survival, metastases-free and overall survival after two years, of patients with locally advanced head and neck cancer.
Outline: This is a multicenter observational study. The treatment is based on the center specific standard of care. The total dose will be between 69 and 73 Gy (definitive treatment) and 63 and 66 Gy (adjuvant treatment), the chemotherapy will be cisplatin- based.
The aim of the analysis is to validate the prognostic impact of potential biomarkers on loco-regional control. This will lead to the definition of risk groups and stratification of patients and will help to individualize radiotherapy prescription in future trials.
- Conditions
- Head and Neck Cancer
- Being tested
- Biomarker analyses head & neck cancer tissue, blood specimen
- Keywords
- locally advanced head and neck cancer, biomarkers, definitive treatment, adjuvant treatment, radiochemotherapy
- 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.
Biomarker analyses head & neck cancer tissue, blood specimenBiological
For biomarker analyses, tumor tissues from previous biopsies and surgery and blood specimens taken during treatment at the treating institution will be used.
| Study group | Role | What they receive |
|---|---|---|
| Biomarker analyses head & neck cancer tissue, blood specimen | Validation of prognostic biomarkers for local tumor control in definitive and adjuvant treatment of head and neck cancer. Receives: Biological: Biomarker analyses head & neck cancer tissue, blood specimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
local recurrence free survival
Measured: after 2 years
Secondary outcomes (3)
disease-free survival
Measured: after 2 years
metastases-free survival
Measured: after 2 years
overall survival
Measured: after 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2014 (estimated)
- Study startMar 2014
- Primary completionJun 2022
- Study completionJun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 Technische Universität DresdenThe 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
- 588 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mechthild Krause, Technische Universität Dresden
- Investigators
- Mechthild Krause, Prof., Principal investigator, Dresden University of Technology, Universital Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02059668
- Sponsor's protocol ID
- STR- HNprädBio-2013
- Acronym
- HNprädBio
- Status last verified
- Aug 2022
- First submitted
- 10 Feb 2014
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tawk B, Halec G, Rein K, Schwager C, Knoll M, Wirkner U, Held T, Weykamp F, Liermann J, Hoerner-Rieber J, Kurth I, Balermpas P, Rodel C, Fleischmann M, Linge A, Lock S, Lohaus F, Tinhofer I, Krause M, Stuschke M, Grosu AL, Schafer H, Zips D, Combs SE, Belka C, Stenzinger A, Herold-Mende C, Baumann M, Schirmacher P, Debus J, Abdollahi A. A tumor DNA-Methylome derived signature of Hypoxia Identifies HPV-negative head and neck cancer patients at risk for distant metastasis after postoperative radiochemotherapy (PORT-C). Radiother Oncol. 2026 Apr;217:111433. doi: 10.1016/j.radonc.2026.111433. Epub 2026 Feb 9.
PubMed 41672251Niu M, Combs SE, Linge A, Krause M, Baumann M, Lohaus F, Ebert N, Tinhofer I, Budach V, von der Grun J, Rodel F, Grosu AL, Multhoff G. Comparison of the composition of lymphocyte subpopulations in non-relapse and relapse patients with squamous cell carcinoma of the head and neck before, during radiochemotherapy and in the follow-up period: a multicenter prospective study of the German Cancer Consortium Radiation Oncology Group (DKTK-ROG). Radiat Oncol. 2021 Jul 31;16(1):141. doi: 10.1186/s13014-021-01868-5.
PubMed 34332614
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on Biomarkers in Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT02059668
- Acronym / sponsor ID
- HNprädBio / STR- HNprädBio-2013
- Conditions
- Head and Neck Cancer
- Keywords
- locally advanced head and neck cancer, biomarkers, definitive treatment, adjuvant treatment, radiochemotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 588 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jun 2022 (actual)
- Study completion
- Jun 2022 (actual)
- First posted
- 11 Feb 2014 (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 aim of this clinical research project is to validate the prognostic impact of potential biomarkers on loco-regional control of locally advanced head and neck cancer after definitive or adjuvant radiochemotherapy. The treatment is equal to the standard of care.
Potential biomarkers from a previous retrospective study will be validated in this prospective study.
Detailed description
Objectives:
Primary: Evaluation of local-regional recurrence- free survival after two years of patients with locally advanced head and neck cancer who received definitive or adjuvant radiochemotherapy.
Secondary: Evaluation of disease-free -survival, metastases-free and overall survival after two years, of patients with locally advanced head and neck cancer.
Outline: This is a multicenter observational study. The treatment is based on the center specific standard of care. The total dose will be between 69 and 73 Gy (definitive treatment) and 63 and 66 Gy (adjuvant treatment), the chemotherapy will be cisplatin- based.
The aim of the analysis is to validate the prognostic impact of potential biomarkers on loco-regional control. This will lead to the definition of risk groups and stratification of patients and will help to individualize radiotherapy prescription in future trials.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biomarker analyses head & neck cancer tissue, blood specimen | – | Biological: Biomarker analyses head & neck cancer tissue, blood specimenValidation of prognostic biomarkers for local tumor control in definitive and adjuvant treatment of head and neck cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with the diagnosis locally advanced squamous cell carcinoma of the head and neck area
Key inclusion criteria (22 listed)
- Patients with locally advanced squamous cell carcinoma of the oral cavity, oropharynx or hypopharynx
- Stage III or IV without distant metastases
- Patient is able to participate in regular tumor follow-up care
- planned irradiation dose 69-72 Gy
- planned overall treatment time 38-54 days
Key exclusion criteria (23 listed)
- distant metastasis
- contraindication against a cisplatin-based chemotherapy
- planned total irradiation dose <69 Gy and >72 Gy
- planned overall treatment time >54 days or <38 days
- Patient is incapable of giving consent
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 |
|---|---|---|
| Biomarker analyses head & neck cancer tissue, blood specimenFor biomarker analyses, tumor tissues from previous biopsies and surgery and blood specimens taken during treatment at the treating institution will be used. | Biological | Biomarker analyses head & neck cancer tissue, blood specimen |
Primary outcome
local recurrence free survival
Time frame: after 2 years
3 secondary outcomes
disease-free survival
Time frame: after 2 years
metastases-free survival
Time frame: after 2 years
overall survival
Time frame: after 2 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 3 Aug 2022.
- Derived from this study: PubMed 41672251Tawk B, Halec G, Rein K, Schwager C, Knoll M, Wirkner U, Held T, Weykamp F, Liermann J, Hoerner-Rieber J, Kurth I, Balermpas P, Rodel C, Fleischmann M, Linge A, Lock S, Lohaus F, Tinhofer I, Krause M, Stuschke M, Grosu AL, Schafer H, Zips D, Combs SE, Belka C, Stenzinger A, Herold-Mende C, Baumann M, Schirmacher P, Debus J, Abdollahi A. A tumor DNA-Methylome derived signature of Hypoxia Identifies HPV-negative head and neck cancer patients at risk for distant metastasis after postoperative radiochemotherapy (PORT-C). Radiother Oncol. 2026 Apr;217:111433. doi: 10.1016/j.radonc.2026.111433. Epub 2026 Feb 9.
- Derived from this study: PubMed 34332614Niu M, Combs SE, Linge A, Krause M, Baumann M, Lohaus F, Ebert N, Tinhofer I, Budach V, von der Grun J, Rodel F, Grosu AL, Multhoff G. Comparison of the composition of lymphocyte subpopulations in non-relapse and relapse patients with squamous cell carcinoma of the head and neck before, during radiochemotherapy and in the follow-up period: a multicenter prospective study of the German Cancer Consortium Radiation Oncology Group (DKTK-ROG). Radiat Oncol. 2021 Jul 31;16(1):141. doi: 10.1186/s13014-021-01868-5.
- 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. This study is not recruiting at the moment.
Mechthild Krause, Prof. principal investigator
Dresden University of Technology, Universital Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology
10 sites 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 Technische Universität Dresden at 10 sites 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 22 inclusion and 23 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 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
local recurrence free survival (time frame: after 2 years). 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 NCT02059668, which also lists 2 linked publications.
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 3 Aug 2022.