Personalised Postoperative Radiochemotherapy in Patients With Head and Neck Cancer

University Hospital Tuebingen

Status: Completed

Conditions: Head and Neck Cancer

Treatments: Radiation: Integration of PET/MRI in radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02666885

ZPM_Demonstrator_HNC

Details and patient eligibility

About

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.

Enrollment: 49 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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49 participants in 1 patient group

Integration of PET/MRI in radiotherapy

Experimental group

Description:

Integration of pretherapeutical PET/MRI in adjuvant radiotherapy

Treatment:

Radiation: Integration of PET/MRI in radiotherapy