Personalised Postoperative Radiochemotherapy in Patients With Head and Neck Cancer
Not Applicable
Completed
- Conditions
- Head and Neck Cancer
- Registration Number
- NCT02666885
- Lead Sponsor
- University Hospital Tuebingen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 49
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 Disease free survival 2 years after primary diagnosis
Trial Locations
- Locations (1)
University Hospital Tübingen, Department of Radiation Oncology
🇩🇪Tübingen, Baden-Württemberg, Germany
University Hospital Tübingen, Department of Radiation Oncology🇩🇪Tübingen, Baden-Württemberg, Germany