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

Head and Neck Cancer Clinical Trial

— HNprädBio  

Official title:

Observational Study on Biomarkers in Head and Neck Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02059668
• Other study ID #: STR- HNprädBio-2013
• Status: Completed
• Start date: March 2014
• Est. completion date: June 2022

Study information

• Verified date: August 2022
• Source: Technische Universität Dresden
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. Potential biomarkers from a previous retrospective study will be validated in this prospective study.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 588
• Est. completion date: June 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Germany	Prof. Volker Budach	Berlin
Germany	Praxis für Strahlentherapie im Krankenhaus Dresden - Friedrichstadt	Dresden
Germany	Prof. Mechthild Krause	Dresden	Saxony
Germany	Prof. Martin Stuschke	Essen	North Rhine-Westphalia
Germany	Prof. Claus Rödel	Frankfurt	Hesse
Germany	Prof. Anca-Ligia Grosu	Freiburg	Baden-Wuerttemberg
Germany	Prof. Jürgen Debus	Heidelberg	Baden-Wuerttemberg
Germany	Prof. Claus Belka	München	Bavaria
Germany	Prof. Stephanie Combs	München	Bavaria
Germany	Prof. Daniel Zips	Tübingen	Baden-Wuerttemberg

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	local recurrence free survival		after 2 years
Secondary	disease-free survival		after 2 years
Secondary	metastases-free survival		after 2 years
Secondary	overall survival		after 2 years