NCT01182779

Brief Summary

This study is a prospective randomised clinical phase III trial. The primary objective of this study is to evaluate, if the innovative therapy (carbon ion irradiation) in chordomas is superior to the standard proton treatment with respect to the local-progression free survival (LPFS).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
319

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jul 2010

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

July 26, 2010

Completed
22 days until next milestone

First Posted

Study publicly available on registry

August 17, 2010

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

August 17, 2010

Status Verified

July 1, 2010

Enrollment Period

5.1 years

First QC Date

July 26, 2010

Last Update Submit

August 16, 2010

Conditions

ChordomaTumorTreatment

Keywords

base of skull chordomaradiationcarbon ionsprotons

Outcome Measures

Primary Outcomes (1)

  • local-progression free survival (LPFS)

    The primary objective of this study is to evaluate, if the innovative therapy (carbon ion irradiation) in chordomas is superior to the standard proton treatment with respect to the LPFS defined as time from the randomisation to observed local reccurrence or death from any cause in the absence of documented local disease progression. Lo-cal recurrence defined as MRT or CT - morphological tumor progress in the former irradiated region. A 10% increase in the LPFS is considered clinically relevant as-suming that the LPFS rate for the proton therapy is 70%.

    8-years

Secondary Outcomes (3)

  • Survival

    8-years

  • Local control and patterns of recurrence

    8 years

  • Toxicity

    8 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 - 63 Gy E ± 5%, further 5-7 fractions a 3 Gy E.

Radiation: Carbon ion

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, 28 fractions Total dose to the PTV1 - 72 Gy E ± 5%, further 6-9 fractions a 2 Gy E.

Radiation: Protons

Interventions

Carbon ionRADIATION

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 - 63 Gy E ± 5%, further 5-7 fractions a 3 Gy E.

A
ProtonsRADIATION

Arm B (proton therapy): Total dose to the PTV2 - 50 to 56 Gy E in 2 Gy E /d, 4-6 days a week, 28 fractions Total dose to the PTV1 - 72 Gy E ± 5%, further 6-9 fractions a 2 Gy E.

B

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 chordoma 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Heidelberg

Heidelberg, 69120, Germany

RECRUITING

Related Publications (8)

  • 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: 10394399BACKGROUND

  • 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: 19386442BACKGROUND

  • Hug EB. Review of skull base chordomas: prognostic factors and long-term results of proton-beam radiotherapy. Neurosurg Focus. 2001 Mar 15;10(3):E11. doi: 10.3171/foc.2001.10.3.12.

    PMID: 16734403BACKGROUND

  • 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: 11082173BACKGROUND

  • 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: 16168833BACKGROUND

  • Schulz-Ertner D, Karger CP, Feuerhake A, Nikoghosyan A, Combs SE, Jakel O, Edler L, Scholz M, Debus J. Effectiveness of carbon ion radiotherapy in the treatment of skull-base chordomas. Int J Radiat Oncol Biol Phys. 2007 Jun 1;68(2):449-57. doi: 10.1016/j.ijrobp.2006.12.059. Epub 2007 Mar 23.

    PMID: 17363188BACKGROUND

  • Mizoe JE, Hasegawa A, Takagi R, Bessho H, Onda T, Tsujii H. Carbon ion radiotherapy for skull base chordoma. Skull Base. 2009 May;19(3):219-24. doi: 10.1055/s-0028-1114295.

    PMID: 19881902BACKGROUND

  • Nikoghosyan AV, Karapanagiotou-Schenkel I, Munter MW, Jensen AD, Combs SE, Debus J. Randomised trial of proton vs. carbon ion radiation therapy in patients with chordoma of the skull base, clinical phase III study HIT-1-Study. BMC Cancer. 2010 Nov 5;10:607. doi: 10.1186/1471-2407-10-607.

    PMID: 21054824DERIVED

MeSH Terms

Conditions

ChordomaNeoplasms

Interventions

Protons

Condition Hierarchy (Ancestors)

Neoplasms, Germ Cell and EmbryonalNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Cations, MonovalentCationsIonsElectrolytesInorganic ChemicalsHydrogenElementsGasesNucleonsElementary ParticlesPhysical Phenomena

Study Officials

  • Juergen Debus, MD PhD

    Heidelberg University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna V. Nikoghosyan, MD

CONTACT

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

Juergen Debus, MD, PhD

CONTACT

+496221568202juergen.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

July 26, 2010

First Posted

August 17, 2010

Study Start

July 1, 2010

Primary Completion

August 1, 2015

Study Completion

August 1, 2023

Last Updated

August 17, 2010

Record last verified: 2010-07

Locations

DE(1)