Clinical trial NCT02059668: Observational Study on Biomarkers in Head and Neck Cancer (HNprädBio)
Official title: Observational Study on Biomarkers in Head and Neck Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Cancer
Keywords: locally advanced head and neck cancer
biomarkers
definitive treatment
adjuvant treatment
radiochemotherapy
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2014-02-11
Enrollment: 588
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with the diagnosis locally advanced squamous cell carcinoma of the head and neck area

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.

Eligibility 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

Primary outcomes:
measure: local recurrence free survival
timeFrame: after 2 years
Secondary outcomes:
measure: disease-free survival
timeFrame: after 2 years
measure: metastases-free survival
timeFrame: after 2 years
measure: overall survival
timeFrame: after 2 years
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: Prof. Anca-Ligia Grosu
state: Baden-Wuerttemberg
city: Heidelberg
country: Germany
facility: Prof. Jürgen Debus
state: Baden-Wuerttemberg
city: Tübingen
country: Germany
facility: Prof. Daniel Zips
state: Baden-Wuerttemberg
city: München
country: Germany
facility: Prof. Claus Belka
state: Bavaria
city: München
country: Germany
facility: Prof. Stephanie Combs
state: Bavaria
city: Frankfurt
country: Germany
facility: Prof. Claus Rödel
state: Hesse
city: Essen
country: Germany
facility: Prof. Martin Stuschke
state: North Rhine-Westphalia
city: Dresden
country: Germany
facility: Prof. Mechthild Krause
state: Saxony
city: Berlin
country: Germany
facility: Prof. Volker Budach
city: Dresden
country: Germany
facility: Praxis für Strahlentherapie im Krankenhaus Dresden - Friedrichstadt
Study officials:
affiliation: Dresden University of Technology, Universital Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology
name: Mechthild Krause, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.