Personalised Postoperative Radiochemotherapy in Patients With Head and Neck Cancer
1 other identifier
interventional
49
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable head-and-neck-cancer
Started Jul 2015
Typical duration for not_applicable head-and-neck-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 10, 2015
CompletedFirst Posted
Study publicly available on registry
January 28, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2019
CompletedSeptember 24, 2019
February 1, 2018
3.9 years
December 10, 2015
September 19, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
2 years after primary diagnosis
Secondary Outcomes (3)
Disease free survival
2 years after primary diagnosis
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
Study Arms (1)
Integration of PET/MRI in radiotherapy
EXPERIMENTALIntegration of pretherapeutical PET/MRI in adjuvant radiotherapy
Interventions
Integration of pretherapeutical PET/MRI in adjuvant radiotherapy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Secondary malignancies that might influence outcome within 2 years after radiochemotherapy of the HNSCC
- previous PET/CT
- induction therapy
- pregnancy or breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Tübingen, Department of Radiation Oncology
Tübingen, Baden-Wurttemberg, 72076, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel Zips, MD, Prof
University Hospital Tuebingen, Department of Radiation Oncology, Tuebingen, Germany
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 10, 2015
First Posted
January 28, 2016
Study Start
July 1, 2015
Primary Completion
June 1, 2019
Study Completion
August 1, 2019
Last Updated
September 24, 2019
Record last verified: 2018-02
Data Sharing
- IPD Sharing
- Will share