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OpenTrials
Completed

NCT Number: NCT02666885

Personalised Postoperative Radiochemotherapy in Patients With Head and Neck Cancer

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.

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Tübingen, Department of Radiation Oncology

Tübingen, Baden-Wurttemberg, 72076, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Integration of PET/MRI in radiotherapy

Radiation

Integration of pretherapeutical PET/MRI in adjuvant radiotherapy

Primary outcomes

  1. locoregional progression free survival

    Time frame: 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 outcomes

  1. Disease free survival

    Time frame: 2 years after primary diagnosis

  2. Overall survival

    Time frame: 2 years after primary diagnosis

  3. Development of a multi-parametric decision support system

    Time frame: after termination of recruitment and follow up up to 5 years

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Official study title

Personalised Postoperative Radiochemotherapy in Patients With Head and Neck Cancer and Development of a Multi-parametric Decision Support System for Personalised Medicine in Radiation Oncology

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jan 28, 2016
Registry last updated
Sep 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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