The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Improvement of Local Control in Skull Base, Spine and Sacral Chordomas Treated by Surgery and Protontherapy Targeting Hypoxic Cells Revealed by [18F]FAZA) PET/CT Tracers (PROTONCHORDE01)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02802969
Recruitment Status : Active, not recruiting
First Posted : June 16, 2016
Last Update Posted : February 16, 2024
Sponsor:
Information provided by (Responsible Party):
Institut Curie

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Improved local control of chordoma initially treated with surgery or not, thanks to adjuvant radiotherapy oriented by conventional imaging Computed Tomography /Magnetic Resonance Imaging (CT / MRI) and guided by the [18Fluor] ([18F]) Fluoroazomycin Arabinofuranoside (FAZA) Positron Emission Tomography / Computed Tomography (PET / CT) to target the radioresistant hypoxic cells.

Condition or disease Intervention/treatment Phase
Skull Base Chordoma Vertebral Chordoma Procedure: Surgery Radiation: Protontherapy Drug: 18F FAZA Phase 2

Detailed Description:

Due to the close contacts of the lesion with the neurovascular structures, in the case of skull base chordoma and mobile spine, surgery is often incomplete. On the contrary, surgery of the sacral region (for which the block excision is often possible) brings a better therapeutic outcome. Radiotherapy with high-dose supplement improves the outcomes for all these lesions.

Intratumoral hypoxia is a primary factor of radioresistance, it's known since long by radiation oncologists. [18F]FAZA gives an image of the hypoxic volume target. Investigators propose to increase the radioactive dose in the hypoxic volume target but in order to succeed, radiation oncologists have to precisely identify this hypoxic volume. Radiation oncologists would increase of 10% the radioactive dose that will allow us to improve local control at 3 years of 15% without any additional side effect.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improvement of Local Control in Skull Base, Spine and Sacral Chordomas Treated by Surgery and Protontherapy Targeting Hypoxic Cells Revealed by [18F]FAZA) PET/CT Tracers
Actual Study Start Date : July 22, 2016
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Chordoma

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: [18F]FAZA PET/CT
In residual chordoma tumors after surgery, Investigators propose a protontherapy guided by conventional imaging (CT/MRI) and a boost guided by FAZA PET/CT, in order to target the hypoxic zones and to increase the dose in an adequate manner, which could result in improving long-term local control and reducing complications.
 Procedure: Surgery

The operative approach and operating time will be performed according to neurosurgical practices (for head and neck) or surgical orthopaedic team (for sacrum) depending on the location, the extension and the relationship of the lesion to critical structures.

The surgery can be macroscopically complete or incomplete.


Radiation: Protontherapy
Radiotherapy will be done with the Cyclotron, for a total dose of 78 Gray Relative Biological Effective (Gy RBE) - 70 Gy RBE to the tumor bed and macroscopic volume and 8 Gy RBE to the the hypoxic component volume, delivered in 39 fractions spread over 67 days.

Drug: 18F FAZA
FAZA PET/CT, in order to target the hypoxic zones
Other Name: 18F FLUOROAZOMYCIN-ARABINOFURANOSIDE


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Improvement local control of chordomas according to RECIST criteria. [ Time Frame: 36 months ]
    Rate of local control at 3 years

  2. Improvement local control of chordomas according to PERCIST criteria [ Time Frame: 36 months ]
    Rate of local control at 3 years


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Typical chordoma and chondroid chordoma of the skull base, spine or chordoma of sacral region
  • Patient undergoing an additional or exclusive radiotherapy (Photontherapy and/or Prothontherapy)
  • Age ≥ 18 years old
  • ECOG performance status 0 to 2

  • Satisfying biological functions 28 days before inclusion :

    1. Haemoglobin ≥ 9 g/dL
    2. Neutrophils ≥ 1500/mm3
    3. Platelets ≥ 100 000/mm3
    4. ASAT, ALAT, GGT, PAL ≤ 1.5 N, bilirubin ≤ 40 μmol/L, LDH ≤ 1.5 N
    5. Creatininemia < 1.5 N
  • Satisfying vital cardiac and respiratory functions
  • Neurologic functions well stabilised
  • Effective contraception for women of childbearing age during the the protontherapy treatment and during the month following the end of treatment. A pregnancy test shall be negative at inclusion.
  • Patient covered by health insurance
  • Patient provided with information and signature of informed consent.

Exclusion Criteria:

  • Dedifferentiated chordomas, chondrosarcoma
  • History of cancer (except cutaneous basocellular epithelioma or epithelioma of the uterine cervix) having recurred in the 5 years preceding entry in the trial and no relapse in the last 3 years
  • Metastatic patient
  • History of brain radiation therapy, or base of the skull or spinal segments to be treated
  • Contraindications to radiotherapy
  • Contraindications to PET/CT examinations [18F] Fluorodexoxyglucose (FDG) and [18]FAZA
  • Associated pathology likely to prevent the patient from receiving treatment,
  • Incompatible treatment with the inclusion in the study (oxygen therapy, EPO, anti-vascular treatments, anti-angiogenic treatments)
  • Patient already included in another therapeutic trial with an experimental medication,
  • Patient currently nursing,
  • Persons deprived of their liberty, or under guardianship,
  • Impossibility of undergoing the trial's medical follow-up for geographical, social or psychological reasons.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT02802969


Locations
Layout table for location information
France
Institut Curie - Hôpital René Huguenin
Saint-Cloud, Ile De France, France, 92210
Sponsors and Collaborators
Institut Curie
Investigators
Layout table for investigator information
Principal Investigator: Hamid MAMMAR, MD Institut Curie
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Institut Curie
ClinicalTrials.gov Identifier: NCT02802969    
Other Study ID Numbers: IC 2014-16
First Posted: June 16, 2016    Key Record Dates
Last Update Posted: February 16, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Investigators will share de-identified data sets with interested researchers, educators or clinicians. Materials generated under the project will be disseminated in accordance with Institut Curie policies.
Time Frame: Data requests can be submitted starting 9 months after article publication and will be made accessible for up to 12 months.
Access Criteria: Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific reserach, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).
Additional relevant MeSH terms:
Layout table for MeSH terms
Chordoma
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
 Fluoroazomycin arabinoside
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action