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Trial record 35 of 1353 for:    Recruiting, Not yet recruiting, Available Studies | "Head and Neck Neoplasms"

Observational Study on Biomarkers in Head and Neck Cancer (HNprädBio) (HNprädBio)

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ClinicalTrials.gov Identifier: NCT02059668
Recruitment Status : Recruiting
First Posted : February 11, 2014
Last Update Posted : November 7, 2017
Sponsor:
Information provided by (Responsible Party):
Mechthild Krause, Technische Universität Dresden

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.


Condition or disease Intervention/treatment
Head and Neck Cancer Biological: Biomarker analyses head & neck cancer tissue, blood specimen

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 Type : Observational
Estimated Enrollment : 550 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study on Biomarkers in Head and Neck Cancer
Study Start Date : March 2014
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Biological: Biomarker analyses head & neck cancer tissue, blood specimen
For biomarker analyses, tumor tissues from previous biopsies and surgery and blood specimens taken during treatment at the treating institution will be used.




Primary Outcome Measures :
  1. local recurrence free survival [ Time Frame: after 2 years ]

Secondary Outcome Measures :
  1. disease-free survival [ Time Frame: after 2 years ]
  2. metastases-free survival [ Time Frame: after 2 years ]
  3. overall survival [ Time Frame: after 2 years ]

Biospecimen Retention:   Samples With DNA
if possible fresh-frozen tumor tissues, blood samples


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with the diagnosis locally advanced squamous cell carcinoma of the head and neck area
Criteria

Inclusion Criteria:

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
  • 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)

Exclusion Criteria:

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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02059668


Contacts
Contact: Mechthild Krause, Prof. +49 351 458 2238 str.studien@uniklinikum-dresden.de

Locations
Germany
Prof. Anca-Ligia Grosu Recruiting
Freiburg, Baden-Wuerttemberg, Germany, 79106
Contact: Anca-Ligia Grosu, Prof.    +49 761 270 94610    anca.grosu@uniklinik-freiburg.de   
Principal Investigator: Ana-Ligia Grosu, Prof.         
Prof. Jürgen Debus Recruiting
Heidelberg, Baden-Wuerttemberg, Germany, 69120
Contact: Jürgen Debus, Prof.    +49 6221 / 56 82 01    Juergen.Debus@med.uni-heidelberg.de   
Principal Investigator: Jürgen Debus, Prof.         
Prof. Daniel Zips Recruiting
Tübingen, Baden-Wuerttemberg, Germany, 72016
Contact: Daniel Zips, Prof.    +49 7071/29-8 21 65    ROInfo@med.uni-tuebingen.de   
Principal Investigator: Daniel Zips, Prof.         
Prof. Claus Belka Recruiting
München, Bavaria, Germany, 81377
Contact: Claus Belka, Prof.    +49 89 7095 4520    Claus.Belka@med.uni-muenchen.de   
Principal Investigator: Claus Belka, Prof.         
Prof. Stephanie Combs Recruiting
München, Bavaria, Germany, 81675
Contact: Stephanie Combs, Prof.    +49 89 41 40-45 02    radonk@lrz.tum.de   
Principal Investigator: Stephanie Combs, Prof.         
Prof. Claus Rödel Recruiting
Frankfurt, Hesse, Germany, 60590
Contact: Claus Rödel, Prof.    + 49 69 / 6301-5130    strahlentherapie@kgu.de   
Principal Investigator: Claus Rödel, Prof.         
Prof. Martin Stuschke Recruiting
Essen, North Rhine-Westphalia, Germany, 45147
Contact: Martin Stuschke, Prof.    +49 201 / 723-23 20    martin.stuschke@uk-essen.de   
Principal Investigator: Martin Stuschke, Prof.         
Prof. Mechthild Krause Recruiting
Dresden, Saxony, Germany, 01307
Contact: Mechthild Krause, Prof.    +49 351 458 2238    studien.str@uniklinikum-dresden.de   
Principal Investigator: Mechthild Krause, Prof.         
Prof. Volker Budach Recruiting
Berlin, Germany, 10117
Contact: Volker Budach, Prof.    +49 30 450 527 152      
Principal Investigator: Volker Budach, Prof.         
Praxis für Strahlentherapie im Krankenhaus Dresden - Friedrichstadt Recruiting
Dresden, Germany, 01067
Contact: Schreiber Andreas, Dr.       strahlentherapie@khdf.de   
Sponsors and Collaborators
Technische Universität Dresden
Investigators
Principal Investigator: Mechthild Krause, Prof. Dresden University of Technology, Universital Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology

Responsible Party: Mechthild Krause, Prof. Dr. Mechthild Krause, Technische Universität Dresden
ClinicalTrials.gov Identifier: NCT02059668     History of Changes
Other Study ID Numbers: STR- HNprädBio-2013
First Posted: February 11, 2014    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mechthild Krause, Technische Universität Dresden:
locally advanced head and neck cancer
biomarkers
definitive treatment
adjuvant treatment
radiochemotherapy

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms