Personalised Postoperative Radiochemotherapy in Patients With Head and Neck Cancer

NCT ID: NCT02666885

Last Updated: 2019-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2019-08-31

Brief Summary

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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

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Conditions

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Head and Neck Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Integration of PET/MRI in radiotherapy

Integration of pretherapeutical PET/MRI in adjuvant radiotherapy

Group Type EXPERIMENTAL

Integration of PET/MRI in radiotherapy

Intervention Type RADIATION

Integration of pretherapeutical PET/MRI in adjuvant radiotherapy

Interventions

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Integration of PET/MRI in radiotherapy

Integration of pretherapeutical PET/MRI in adjuvant radiotherapy

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel Zips, MD, Prof

Role: PRINCIPAL_INVESTIGATOR

University Hospital Tuebingen, Department of Radiation Oncology, Tuebingen, Germany

Locations

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University Hospital Tübingen, Department of Radiation Oncology

Tübingen, Baden-Wurttemberg, Germany

Site Status

Countries

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Germany

Other Identifiers

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ZPM_Demonstrator_HNC

Identifier Type: -

Identifier Source: org_study_id

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