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Trial record 1 of 1 for:    NCT01182779
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Trial of Proton Versus Carbon Ion Radiation Therapy in Patients With Chordoma of the Skull Base (HIT-1)

This study is currently recruiting participants.
Verified July 2010 by Heidelberg University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01182779
First Posted: August 17, 2010
Last Update Posted: August 17, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by:
Heidelberg University
  Purpose
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).

Condition Intervention Phase
Chordoma Tumor Treatment Radiation: Carbon ion Radiation: Protons Phase 3

Study Type: Interventional
Study Design: 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 Chordoma of the Skull Base -Clinical Phase III Study-

Resource links provided by NLM:


Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • local-progression free survival (LPFS) [ Time Frame: 8-years ]
    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%.


Secondary Outcome Measures:
  • Survival [ Time Frame: 8-years ]
    Assessment of overall survival, progression free and metastasis free survival.

  • Local control and patterns of recurrence [ Time Frame: 8 years ]
    Local recurrences will be confirmed radiologically and histologically whenever possible. At least two medical doctors (radiation oncologist and/or radiologist) will be required to judge of the recurrence.

  • Toxicity [ Time Frame: 8 years ]
    Acute and late toxicity will be analysed due to Common Terminology Criteria for Adverse Events: CTCAE V4.0 for acute reaction and RTOG/EORTC for late effects.


Estimated Enrollment: 319
Study Start Date: July 2010
Estimated Study Completion Date: August 2023
Estimated Primary Completion Date: August 2015 (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 - 63 Gy E ± 5%, further 5-7 fractions a 3 Gy E.

Radiation: Carbon ion

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.

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

Radiation: Protons

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.


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 skull base chordomas. 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 chordoma will be randomised to either proton or carbon ion radiation therapy. As a standard, patients will undergo non-invasive, rigid immobilization and target volume delineation will be carried out based on CT and MRI data. The biologically isoeffective target dose to the PTV in carbon ion treatment (accelerated dose) will be 63 Gy E ± 5% and 72 Gy E ± 5% (standard dose) in proton therapy respectively. Local-progression free survival (LPFS) will be analysed as primary end point. Toxicity and survival are the secondary end points. Also matters of interest are patterns of recurrence, prognostic factors and plan quality.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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 chordoma 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): NCT01182779


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, Germany, 69120
Principal Investigator: Juergen Debus, MD, PhD         
Sub-Investigator: Anna V. Nikoghosyan, MD         
Sponsors and Collaborators
Heidelberg University
Investigators
Principal Investigator: Juergen Debus, MD PhD Heidelberg University
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Juergen Debus, MD PhD, Dept. of Radiation Oncology, INF 400, 69120 Heidelberg, University of Heidelberg
ClinicalTrials.gov Identifier: NCT01182779     History of Changes
Other Study ID Numbers: HIT-1
First Submitted: July 26, 2010
First Posted: August 17, 2010
Last Update Posted: August 17, 2010
Last Verified: July 2010

Keywords provided by Heidelberg University:
base of skull chordoma
radiation
carbon ions
protons

Additional relevant MeSH terms:
Chordoma
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms