Status:
UNKNOWN
Trial of Proton Versus Carbon Ion Radiation Therapy in Patients With Chordoma of the Skull Base
Lead Sponsor:
Heidelberg University
Conditions:
Chordoma
Tumor
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
This study is a prospective randomised clinical phase III trial. The primary objective of this study is to evaluate, if the innovative therapy (carbon ion irradiation) in chordomas is superior to the ...
Detailed Description
The study is a prospective randomised clinical phase III trial. The trial will be carried out at Heidelberger Ionenstrahl-Therapie (HIT) centre as monocentric trial. Proton therapy is the gold standa...
Eligibility Criteria
Inclusion
- Karnofsky Performance Score ≥60%
- Age \>18 years and \<80 years
- Informed consent signed by the patient
- Histological confirmation of chordoma with infiltration of the skull base.
Exclusion
- Inability to understand the aims of the study, no informed consent
- Prior RT of skull base region
- Other malignancies with disease-free interval \< 5 years (excepting pre- cancerous lesions)
- Participation in another trial
- Pregnancy
- Simultaneous CHT or Immunotherapy.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2023
Estimated Enrollment :
319 Patients enrolled
Trial Details
Trial ID
NCT01182779
Start Date
July 1 2010
End Date
August 1 2023
Last Update
August 17 2010
Active Locations (1)
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1
University of Heidelberg
Heidelberg, Germany, 69120