Personalised Postoperative Radiochemotherapy in Patients With Head and Neck Cancer

Not Applicable

Completed

• Conditions: Head and Neck Cancer
• Interventions: Radiation: Integration of PET/MRI in radiotherapy

• 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

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-12-10
• Study First Submitted QC: 2016-01-25
• Study First Posted: 2016-01-28
• Status Verified: 2018-02
• Primary Completion: 2019-06
• Study Completion: 2019-08
• Last Update Submitted: 2019-09-19
• Last Update Posted: 2019-09-24

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

Arm && Interventions

Group	Intervention	Description
Integration of PET/MRI in radiotherapy	Integration of PET/MRI in radiotherapy	Integration of pretherapeutical PET/MRI in adjuvant radiotherapy

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