Randomised Trial of Proton vs. Carbon Ion Radiation Therapy in Patients With Low and Inter-mediate Grade Chondrosarcoma of the Skull Base, Clinical Phase III Study
18 Years
80 Years
Both
Chondrosarcoma
Trial Information
Randomised Trial of Proton vs. Carbon Ion Radiation Therapy in Patients With Low and Inter-mediate Grade Chondrosarcoma of the Skull Base, Clinical Phase III Study
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 standard in the treatment of low and intermediate grad
chondrosarcomas of the skull base. However, high-LET beams such as carbon ions theoretically
offer biologic advantages by enhanced biologic effectiveness in slow-growing tumors. Up
until now it was impossible to compare two different particle therapies, i.e. proton and
carbon ion therapy directly with each other. The aim of this study is to find out, whether
the biological advantages of carbon ion therapy mentioned above can also be clinically
confirmed.
Patients with skull base chondrosarcomas will be randomised to either proton or carbon ion
radiation therapy. As a standard, patients will undergo non-invasive, rigid immobilization
and target volume definition will be carried out based on CT and MRI data. The biologically
isoeffective target dose to the PTV in carbon ion treatment will be 60 Gy E ± 5% and 70 Gy E
± 5% (standard dose) in proton therapy respectively. The 5 year local-progression free
survival (LPFS) rate will be analysed as primary end point. Overall survival, progression
free and metastasis free survival, patterns of recurrence, local control rate and morbidity
are the secondary end points. Plan quality is also a matter of interest.
Inclusion Criteria:
- 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 Criteria:
- 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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Local-Progression Free Survival (LPFS)
Outcome Description:
The primary objective of this study is to evaluate, if the innovative carbon ion therapy in chondrosarcomas is not relevantly inferior to the standard proton treatment with respect to the 5 year LPFS rate defined as time from the randomisation to observed local reccurrence. It is assumed that the LPFS rate for the proton therapy is 90%.
Outcome Time Frame:
5 years
Safety Issue:
Yes
Principal Investigator
Juergen Debus, MD PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Heidelberg
Authority:
Germany: Bundesamt für Strahlenschutz
Study ID:
CS.P.12C
NCT ID:
NCT01182753
Start Date:
August 2010
Completion Date:
August 2022
Related Keywords:
- Chondrosarcoma
- Chondrosarcoma
- Radiation
- carbon ion
- Chondrosarcoma
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