Observational Study on Biomarkers in Head and Neck Cancer (HNprädBio)
HNprädBio
1 other identifier
observational
588
1 country
10
Brief 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. Potential biomarkers from a previous retrospective study will be validated in this prospective study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2014
Longer than P75 for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2014
CompletedFirst Posted
Study publicly available on registry
February 11, 2014
CompletedStudy Start
First participant enrolled
March 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2022
CompletedAugust 3, 2022
August 1, 2022
8.3 years
February 10, 2014
August 2, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
local recurrence free survival
after 2 years
Secondary Outcomes (3)
disease-free survival
after 2 years
metastases-free survival
after 2 years
overall survival
after 2 years
Study Arms (1)
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.
Interventions
For biomarker analyses, tumor tissues from previous biopsies and surgery and blood specimens taken during treatment at the treating institution will be used.
Eligibility Criteria
Patients with the diagnosis locally advanced squamous cell carcinoma of the head and neck area
You may qualify if:
- 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
- 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
- +7 more criteria
You may not qualify if:
- 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
- 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
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Prof. Anca-Ligia Grosu
Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
Prof. Jürgen Debus
Heidelberg, Baden-Wurttemberg, 69120, Germany
Prof. Daniel Zips
Tübingen, Baden-Wurttemberg, 72016, Germany
Prof. Claus Belka
München, Bavaria, 81377, Germany
Prof. Stephanie Combs
München, Bavaria, 81675, Germany
Prof. Claus Rödel
Frankfurt am Main, Hesse, 60590, Germany
Prof. Martin Stuschke
Essen, North Rhine-Westphalia, 45147, Germany
Prof. Mechthild Krause
Dresden, Saxony, 01307, Germany
Prof. Volker Budach
Berlin, 10117, Germany
Praxis für Strahlentherapie im Krankenhaus Dresden - Friedrichstadt
Dresden, 01067, Germany
Related Publications (1)
Niu 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.
PMID: 34332614DERIVED
Biospecimen
if possible fresh-frozen tumor tissues, blood samples
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mechthild Krause, Prof.
Dresden University of Technology, Universital Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr. Mechthild Krause
Study Record Dates
First Submitted
February 10, 2014
First Posted
February 11, 2014
Study Start
March 1, 2014
Primary Completion
June 1, 2022
Study Completion
June 1, 2022
Last Updated
August 3, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share