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

NCT01182753 | Unknown Phase 3

• 1 other identifier: CS.P.12C
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

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.

Conditions

Chondrosarcoma

Keywords

Chondrosarcoma; Radiation; carbon ion

Outcome Measures

Primary Outcomes (1)

• Local-Progression Free Survival (LPFS)

  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%.

  5 years

Secondary Outcomes (3)

• Survival

  12 years

• Toxicity

  12 years

• Patterns of recurrence and local control rate

  5 years

Study Arms (2)

A

EXPERIMENTAL

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

B

ACTIVE COMPARATOR

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

Interventions

carbon ion therapy RADIATION

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.

A

proton therapy RADIATION

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.

B

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Heidelberg University: lead

Study Sites (1)

University of Heidelberg

Heidelberg, Im Neuenheimer Feld 400, 69120, Germany

RECRUITING

Related Publications (7)

• 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.

  PMID: 17056193 BACKGROUND

• 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.

  PMID: 10394399 BACKGROUND

• 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.

  PMID: 19386442 BACKGROUND

• 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.

  PMID: 11082173 BACKGROUND

• 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.

  PMID: 10470818 BACKGROUND

• 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.

  PMID: 16168833 BACKGROUND

• 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.

  PMID: 21050498 DERIVED

MeSH Terms

Conditions

Chondrosarcoma

Interventions

Heavy Ion Radiotherapy; Proton Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics

Study Officials

• Juergen Debus, MD PhD

  Heidelberg University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna V. Nikoghosyan, MD

CONTACT

+496221568202; anna.nikoghosyan@med.uni-heidelberg.de

Juergen Debus, MD, PhD

CONTACT

+496221568202; juergen.debus@med.uni-heidelberg.de

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 12, 2010
• First Posted: August 17, 2010
• Study Start: August 1, 2010
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: August 17, 2010

Record last verified: 2010-08

Locations

DE (1)