Tumor hypoxia measured with F-MISO-PET in the course of irradiation of head and neck cancer: adoption of the method into clinical routine and evaluation of the data

Conditions: C10
C13
Malignant neoplasm of oropharynx
Malignant neoplasm of hypopharynx

Registration Number: DRKS00006007

Lead Sponsor: niversitätsklinikum DresdenKlinik für Strahlentherapie und Radioonkologie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 59

Inclusion Criteria

• age 18-70 years
• inoperable histological confirmed head and neck cancer (squamous cell carcinoma of the pharynx, oral cavity and supraglottis)
• general condition WHO 0-2
• tumor volume and location permit curative radiotherapy

Exclusion Criteria

• distant metastases
• previous irradation in the head and neck region
• second carcinoma except T1 skin cancer and in-Situ-carcinoma of the cervix uteri
• pregnancy
• lack of understanding or lack of cooperation

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ocal progression free survival in case of residual hypoxia (measured as TBRmax > 1.9) after 20Gy radio-chemotherapy. This is measured two years after completion of treatment, a so-called 2-year local progression-free survival. The data of residual hypoxic versus non-hypoxic patients are evaluated according to the Cox proportional hazard model as a comparison of the survival curves.

Secondary Outcome Measures

Name	Time	Method
Further evaluation of oncologic parameters: Overall survival, local control, progression free survival. These are checked after 2 and 5 years. Furthermore measure quality of life and correlation with dosimetric parameters. To measure quality of life, the established EORTC-QLQ-C30 and HN35 sheets are used. The sheets are handed out to the patients before therapy, and twice shortly after the end of treatment. Subsequently once a year to five years after the end of treatment. In addition a correlation of hypoxia markers from blood samples to be taken and FMISO PET parameters and oncological parameters takes place.