Personalised Postoperative Radiochemotherapy in Patients With Head and Neck Cancer

September 19, 2019 updated by: University Hospital Tuebingen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-Württemberg
      • Tübingen, Baden-Württemberg, Germany, 72076
        • University Hospital Tübingen, Department of Radiation Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Integration of PET/MRI in radiotherapy
Integration of pretherapeutical PET/MRI in adjuvant radiotherapy
Radiation: Integration of PET/MRI in radiotherapy
Integration of pretherapeutical PET/MRI in adjuvant radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 years after primary diagnosis

Secondary Outcome Measures

Outcome Measure
Time Frame
Disease free survival
Time Frame: 2 years after primary diagnosis
2 years after primary diagnosis
Overall survival
Time Frame: 2 years after primary diagnosis
2 years after primary diagnosis
Development of a multi-parametric decision support system
Time Frame: after termination of recruitment and follow up up to 5 years
after termination of recruitment and follow up up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Investigators

  • Principal Investigator: Daniel Zips, MD, Prof, University Hospital Tuebingen, Department of Radiation Oncology, Tuebingen, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2015

Primary Completion (Actual)

June 1, 2019

Study Completion (Actual)

August 1, 2019

Study Registration Dates

First Submitted

December 10, 2015

First Submitted That Met QC Criteria

January 25, 2016

First Posted (Estimate)

January 28, 2016

Study Record Updates

Last Update Posted (Actual)

September 24, 2019

Last Update Submitted That Met QC Criteria

September 19, 2019

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZPM_Demonstrator_HNC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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