Back to resultsPersonalised Postoperative Radiochemotherapy in Patients With Head and Neck Cancer
Primary Purpose
Head and Neck Cancer
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Integration of PET/MRI in radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Cancer focused on measuring Personalized Medicine, Radiation Oncology, Functional Imaging, Biomarker, Decision Support System, Radiomics
Eligibility Criteria
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
Sites / Locations
- University Hospital Tübingen, Department of Radiation Oncology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Integration of PET/MRI in radiotherapy
Arm Description
Integration of pretherapeutical PET/MRI in adjuvant radiotherapy
Outcomes
Primary Outcome Measures
locoregional progression free survival
15% improvement in loco-regional PFS at 2 years through integrtion of pre-operative PET/MR imaging into RT treatment planning
Secondary Outcome Measures
Disease free survival
Overall survival
Development of a multi-parametric decision support system
Full Information
NCT ID
NCT02666885
First Posted
December 10, 2015
Last Updated
September 19, 2019
Sponsor
University Hospital Tuebingen
1. Study Identification
Unique Protocol Identification Number
NCT02666885
Brief Title
Personalised Postoperative Radiochemotherapy in Patients With Head and Neck Cancer
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
July 2015 (Actual)
Primary Completion Date
June 2019 (Actual)
Study Completion Date
August 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Tuebingen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
Personalized Medicine, Radiation Oncology, Functional Imaging, Biomarker, Decision Support System, Radiomics
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Integration of PET/MRI in radiotherapy
Arm Type
Experimental
Arm Description
Integration of pretherapeutical PET/MRI in adjuvant radiotherapy
Intervention Type
Radiation
Intervention Name(s)
Integration of PET/MRI in radiotherapy
Intervention Description
Integration of pretherapeutical PET/MRI in adjuvant radiotherapy
Primary Outcome Measure Information:
Title
locoregional progression free survival
Description
15% improvement in loco-regional PFS at 2 years through integrtion of pre-operative PET/MR imaging into RT treatment planning
Time Frame
2 years after primary diagnosis
Secondary Outcome Measure Information:
Title
Disease free survival
Time Frame
2 years after primary diagnosis
Title
Overall survival
Time Frame
2 years after primary diagnosis
Title
Development of a multi-parametric decision support system
Time Frame
after termination of recruitment and follow up up to 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Zips, MD, Prof
Organizational Affiliation
University Hospital Tuebingen, Department of Radiation Oncology, Tuebingen, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Tübingen, Department of Radiation Oncology
City
Tübingen
State/Province
Baden-Württemberg
ZIP/Postal Code
72076
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Personalised Postoperative Radiochemotherapy in Patients With Head and Neck Cancer
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