Head and Neck Cancer
Conditions
Keywords
Personalized Medicine, Radiation Oncology, Functional Imaging, Biomarker, Decision Support System, Radiomics
Brief summary
The current trial is evaluating the integration of a pretherapeutical FDG-PET/MRI in the adjuvant radiochemotherapy in patients with head and neck cancer. As a secondary hypothesis the intention is to develop of a multi-parametric decision support system for personalised medicine by integrating functional imaging, γH2AX-analysis and genetic information.
Interventions
RADIATIONIntegration of PET/MRI in radiotherapy
Integration of pretherapeutical PET/MRI in adjuvant radiotherapy
Sponsors
University Hospital Tuebingen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* locally-advanced HNSCC (Oro- and Hypopharynx) stage III and IV without distant metastases * no contraindications for PET/MRI * no contraindications for radiochemotherapy * informed consent * ECOG PS 0/2
Exclusion criteria
* Secondary malignancies that might influence outcome within 2 years after radiochemotherapy of the HNSCC * previous PET/CT * induction therapy * pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| locoregional progression free survival | 2 years after primary diagnosis | 15% improvement in loco-regional PFS at 2 years through integrtion of pre-operative PET/MR imaging into RT treatment planning |
Secondary
| Measure | Time frame |
|---|---|
| Disease free survival | 2 years after primary diagnosis |
| Overall survival | 2 years after primary diagnosis |
| Development of a multi-parametric decision support system | after termination of recruitment and follow up up to 5 years |
Countries
Germany
Outcome results
None listed