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

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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer
• Intervention / Treatment: 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
• Enrollment (Actual): 588

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Prof. Volker Budach
  • Dresden, Germany, 01067
    • Praxis für Strahlentherapie im Krankenhaus Dresden - Friedrichstadt
  • Baden-Wuerttemberg
    • Freiburg, Baden-Wuerttemberg, Germany, 79106
      • Prof. Anca-Ligia Grosu
    • Heidelberg, Baden-Wuerttemberg, Germany, 69120
      • Prof. Jürgen Debus
    • Tübingen, Baden-Wuerttemberg, Germany, 72016
      • Prof. Daniel Zips
  • Bavaria
    • München, Bavaria, Germany, 81377
      • Prof. Claus Belka
    • München, Bavaria, Germany, 81675
      • Prof. Stephanie Combs
  • Hesse
    • Frankfurt, Hesse, Germany, 60590
      • Prof. Claus Rödel
  • North Rhine-Westphalia
    • Essen, North Rhine-Westphalia, Germany, 45147
      • Prof. Martin Stuschke
  • Saxony
    • Dresden, Saxony, Germany, 01307
      • Prof. Mechthild Krause

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with the diagnosis locally advanced squamous cell carcinoma of the head and neck area

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
local recurrence free survival	after 2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
disease-free survival	after 2 years
metastases-free survival	after 2 years
overall survival	after 2 years

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• Niu M, Combs SE, Linge A, Krause M, Baumann M, Lohaus F, Ebert N, Tinhofer I, Budach V, von der Grün J, Rödel 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): June 1, 2022
• Study Completion (Actual): June 1, 2022

Study Registration Dates

• First Submitted: February 10, 2014
• First Submitted That Met QC Criteria: February 10, 2014
• First Posted (Estimate): February 11, 2014

Study Record Updates

• Last Update Posted (Actual): August 3, 2022
• Last Update Submitted That Met QC Criteria: August 2, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: biomarkers; radiochemotherapy; adjuvant treatment; locally advanced head and neck cancer; definitive treatment
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: STR- HNprädBio-2013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No