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Trial of Proton Versus Carbon Ion Radiation Therapy in Patients With Low and Inter-mediate Grade Chondrosarcoma of the Skull Base (CSP12C)

This study is currently recruiting participants.
Verified August 2010 by University of Heidelberg
Sponsor:
Information provided by:
University of Heidelberg
ClinicalTrials.gov Identifier:
NCT01182753
First received: August 12, 2010
Last updated: August 16, 2010
Last verified: August 2010
History of Changes
  Purpose

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 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.


Condition Intervention Phase
Chondrosarcoma
 Radiation: carbon ion therapy
Radiation: proton therapy
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by University of Heidelberg:

Primary Outcome Measures:
  • Local-Progression Free Survival (LPFS) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    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%.


Secondary Outcome Measures:
  • Survival [ Time Frame: 12 years ] [ Designated as safety issue: Yes ]
    Assessment of overall survival, progression free and metastasis free survival.

  • Toxicity [ Time Frame: 12 years ] [ Designated as safety issue: Yes ]
    Acute and late toxicity will be analysed according to Common Terminology Criteria for Adverse Events: CTCAE V4.0 for acute side effects and RTOG/EORTC for late reaction.

  • Patterns of recurrence and local control rate [ Time Frame: 5 years ]
    Local recurrences will be confirmed radiologically and histologically whenever possi-ble. At least two medical doctors (radiation oncologist and/or radiologist) will be re-quired to judge of the recurrence.


Estimated Enrollment: 154
Study Start Date: August 2010
Estimated Study Completion Date: August 2022
Estimated Primary Completion Date: August 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A

Arm A (carbon ion therapy):

Total dose to the PTV2 - 45 Gy E in 3 Gy E /d, 4 - 6 days a week, 15 fractions Total dose to the PTV1 - 60 Gy E ± 5%, further 4 - 6 fractions a 3 Gy E.

 Radiation: carbon ion therapy

Arm A (carbon ion therapy):

Total dose to the PTV2 - 45 Gy E in 3 Gy E /d, 4 - 6 days a week, 15 fractions Total dose to the PTV1 - 60 Gy E ± 5%, further 4 - 6 fractions a 3 Gy E.
Active Comparator: B

Arm B (proton therapy):

Total dose to the PTV2 - 50 to 56 Gy E in 2 Gy E /d, 4 - 6 days a week, 25 - 28 fractions Total dose to the PTV1 - 70 Gy E ± 5%, further 6 - 10 fractions a 2 Gy E.

 Radiation: proton therapy

Arm B (proton therapy):

Total dose to the PTV2 - 50 to 56 Gy E in 2 Gy E /d, 4 - 6 days a week, 25 - 28 fractions Total dose to the PTV1 - 70 Gy E ± 5%, further 6 - 10 fractions a 2 Gy E.

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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01182753

Contacts
Contact: Anna V. Nikoghosyan, MD +496221568202 anna.nikoghosyan@med.uni-heidelberg.de
Contact: Juergen Debus, MD, PhD +496221568202 juergen.debus@med.uni-heidelberg.de

Locations
Germany
University of Heidelberg Recruiting
Heidelberg, Im neuenheimer Feld 400, Germany, 69120
Contact: Anna V. Nikoghosyan, MD     +49 6221 568202     anna.nikoghosyan@med.uni-heidelberg.de    
Contact: Rebecca Klumpp     +49 6221 5636902     rebecca.klumpp@med.uni-heidelberg.de    
Sponsors and Collaborators
University of Heidelberg
Investigators
Principal Investigator: Juergen Debus, MD PhD University of Heidelberg
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Prof. Dr. Dr. J. Debus, University of Heidelberg
ClinicalTrials.gov Identifier: NCT01182753     History of Changes
Other Study ID Numbers: CS.P.12C
Study First Received: August 12, 2010
Last Updated: August 16, 2010
Health Authority: Germany: Bundesamt für Strahlenschutz

Keywords provided by University of Heidelberg:
Chondrosarcoma
Radiation
carbon ion

Additional relevant MeSH terms:
Chondrosarcoma
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
 Neoplasms by Histologic Type
Neoplasms
Sarcoma

ClinicalTrials.gov processed this record on May 23, 2013