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

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ClinicalTrials.gov Identifier: NCT01182753

Recruitment Status : Unknown

Verified August 2010 by Heidelberg University.
Recruitment status was: Recruiting

First Posted : August 17, 2010

Last Update Posted : August 17, 2010

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Sponsor:

Information provided by:

Heidelberg University

Study Description

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 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 or disease	Intervention/treatment	Phase
Chondrosarcoma	Radiation: carbon ion therapy Radiation: proton therapy	Phase 3

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	154 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (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
Study Start Date :	August 2010
Estimated Primary Completion Date :	August 2022
Estimated Study Completion Date :	August 2022

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Chondrosarcoma Soft Tissue Sarcoma

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

Local-Progression Free Survival (LPFS) [ Time Frame: 5 years ]
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 ]
Assessment of overall survival, progression free and metastasis free survival.
Toxicity [ Time Frame: 12 years ]
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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01182753

Contacts

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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

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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

Heidelberg University

Investigators

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Principal Investigator:	Juergen Debus, MD PhD	Heidelberg University

More Information

Publications:

Schulz-Ertner D, Nikoghosyan A, Hof H, Didinger B, Combs SE, Jakel O, Karger CP, Edler L, Debus J. Carbon ion radiotherapy of skull base chondrosarcomas. Int J Radiat Oncol Biol Phys. 2007 Jan 1;67(1):171-7. doi: 10.1016/j.ijrobp.2006.08.027. Epub 2006 Oct 23.

Munzenrider JE, Liebsch NJ. Proton therapy for tumors of the skull base. Strahlenther Onkol. 1999 Jun;175 Suppl 2:57-63. doi: 10.1007/BF03038890.

Ares C, Hug EB, Lomax AJ, Bolsi A, Timmermann B, Rutz HP, Schuller JC, Pedroni E, Goitein G. Effectiveness and safety of spot scanning proton radiation therapy for chordomas and chondrosarcomas of the skull base: first long-term report. Int J Radiat Oncol Biol Phys. 2009 Nov 15;75(4):1111-8. doi: 10.1016/j.ijrobp.2008.12.055. Epub 2009 Apr 20.

Hug EB, Slater JD. Proton radiation therapy for chordomas and chondrosarcomas of the skull base. Neurosurg Clin N Am. 2000 Oct;11(4):627-38.

Hug EB, Loredo LN, Slater JD, DeVries A, Grove RI, Schaefer RA, Rosenberg AE, Slater JM. Proton radiation therapy for chordomas and chondrosarcomas of the skull base. J Neurosurg. 1999 Sep;91(3):432-9. doi: 10.3171/jns.1999.91.3.0432.

Weber DC, Rutz HP, Pedroni ES, Bolsi A, Timmermann B, Verwey J, Lomax AJ, Goitein G. Results of spot-scanning proton radiation therapy for chordoma and chondrosarcoma of the skull base: the Paul Scherrer Institut experience. Int J Radiat Oncol Biol Phys. 2005 Oct 1;63(2):401-9. doi: 10.1016/j.ijrobp.2005.02.023.

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

Nikoghosyan AV, Rauch G, Munter MW, Jensen AD, Combs SE, Kieser M, Debus J. Randomised trial of proton vs. carbon ion radiation therapy in patients with low and intermediate grade chondrosarcoma of the skull base, clinical phase III study. BMC Cancer. 2010 Nov 5;10:606. doi: 10.1186/1471-2407-10-606.

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Responsible Party:	Prof. Dr. Dr. J. Debus, University of Heidelberg
ClinicalTrials.gov Identifier:	NCT01182753
Other Study ID Numbers:	CS.P.12C
First Posted:	August 17, 2010 Key Record Dates
Last Update Posted:	August 17, 2010
Last Verified:	August 2010

Keywords provided by Heidelberg University:


Chondrosarcoma Radiation carbon ion

Additional relevant MeSH terms:

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Chondrosarcoma Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue	Neoplasms by Histologic Type Neoplasms Sarcoma

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