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

Completed

• Conditions: Head and Neck Cancer
• Interventions: Biological: Biomarker analyses head & neck cancer tissue, blood specimen

• Registration Number: NCT02059668
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2014-02-10
• Study First Submitted QC: 2014-02-10
• Study First Posted: 2014-02-11
• Study Start: 2014-03
• Primary Completion: 2022-06
• Study Completion: 2022-06
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-02
• Last Update Posted: 2022-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 588

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Biomarker analyses head & neck cancer tissue, blood specimen	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.

Primary Outcome Measures

Name	Time	Method
local recurrence free survival	after 2 years

Secondary Outcome Measures

Name	Time	Method
overall survival	after 2 years
disease-free survival	after 2 years
metastases-free survival	after 2 years

Trial Locations

Locations (10)

Prof. Volker Budach; 🇩🇪 Berlin, Germany

Prof. Claus Rödel; 🇩🇪 Frankfurt, Hesse, Germany

Praxis für Strahlentherapie im Krankenhaus Dresden - Friedrichstadt; 🇩🇪 Dresden, Germany

Prof. Jürgen Debus; 🇩🇪 Heidelberg, Baden-Wuerttemberg, Germany

Prof. Anca-Ligia Grosu; 🇩🇪 Freiburg, Baden-Wuerttemberg, Germany

Prof. Daniel Zips; 🇩🇪 Tübingen, Baden-Wuerttemberg, Germany

Prof. Stephanie Combs; 🇩🇪 München, Bavaria, Germany

Prof. Mechthild Krause; 🇩🇪 Dresden, Saxony, Germany

Prof. Claus Belka; 🇩🇪 München, Bavaria, Germany

Prof. Martin Stuschke; 🇩🇪 Essen, North Rhine-Westphalia, Germany