Status:

UNKNOWN

Trial of Proton Versus Carbon Ion Radiation Therapy in Patients With Low and Inter-mediate Grade Chondrosarcoma of the Skull Base

Lead Sponsor:

Heidelberg University

Conditions:

Chondrosarcoma

Eligibility:

All Genders

18-80 years

Phase:

PHASE3

Brief Summary

The study is a prospective randomised clinical phase III trial. Proton therapy is the gold standard in the treatment of low and intermediate grad chondrosarcomas of the skull base. However, high-LET b...

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 low/ intermediate grade chondrosarcoma 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 :

August 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

August 1 2022

Estimated Enrollment :

154 Patients enrolled

Trial Details

Trial ID

NCT01182753

Start Date

August 1 2010

End Date

August 1 2022

Last Update

August 17 2010

Active Locations (1)

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University of Heidelberg

Heidelberg, Im Neuenheimer Feld 400, Germany, 69120