Skull Base ChordomaPhase 2PROTONCHORDE01NCT02802969
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
A Phase 2 study testing Surgery, Protontherapy and 18F FAZA in people with Skull Base Chordoma and Vertebral Chordoma, run by Institut Curie at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skull Base Chordoma, Vertebral Chordoma
- What is being tested?
- Surgery, Protontherapy and 18F FAZA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jul 2016to 28 Nov 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 :
- Haemoglobin ≥ 9 g/dL
Show all 15Show fewer
- Neutrophils ≥ 1500/mm3
- Platelets ≥ 100 000/mm3
- ASAT, ALAT, GGT, PAL ≤ 1.5 N, bilirubin ≤ 40 μmol/L, LDH ≤ 1.5 N
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
Institut Curie - Hôpital René Huguenin
Saint-Cloud, Île-de-France Region, 92210
About this study
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.
Read the 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.
- Conditions
- Skull Base Chordoma, Vertebral Chordoma
- Being tested
- Surgery, Protontherapy, 18F FAZA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or 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.
ProtontherapyRadiation
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.
18F FAZADrug
Also called 18F FLUOROAZOMYCIN-ARABINOFURANOSIDE
FAZA PET/CT, in order to target the hypoxic zones
| Study group | Role | What they receive |
|---|---|---|
| [18F]FAZA PET/CT | Experimental | 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. Receives: Procedure: Surgery; Radiation: Protontherapy; Drug: 18F FAZA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement local control of chordomas according to RECIST criteria.
Rate of local control at 3 years
Measured: 36 months
Improvement local control of chordomas according to PERCIST criteria
Rate of local control at 3 years
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2016 (estimated)
- Study start22 Jul 2016
- Primary completion28 Nov 2024
- Study completion28 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skull Base ChordomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hamid MAMMAR, MD, Principal investigator, Institut Curie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02802969
- Sponsor's protocol ID
- IC 2014-16
- Acronym
- PROTONCHORDE01
- Status last verified
- Sep 2025
- First submitted
- 3 Jun 2016
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02802969
- Acronym / sponsor ID
- PROTONCHORDE01 / IC 2014-16
- Conditions
- Skull Base Chordoma, Vertebral Chordoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- 22 Jul 2016 (actual)
- Primary completion
- 28 Nov 2024 (actual)
- Study completion
- 28 Nov 2024 (actual)
- First posted
- 16 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [18F]FAZA PET/CT | Experimental | Procedure: Surgery, Radiation: Protontherapy, Drug: 18F FAZAIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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 :
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurgeryThe 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. | Procedure or surgery | [18F]FAZA PET/CT |
| ProtontherapyRadiotherapy 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. | Radiation | [18F]FAZA PET/CT |
| 18F FAZAAlso: 18F FLUOROAZOMYCIN-ARABINOFURANOSIDEFAZA PET/CT, in order to target the hypoxic zones | Drug | [18F]FAZA PET/CT |
Primary outcome
Improvement local control of chordomas according to RECIST criteria.
Time frame: 36 months
Rate of local control at 3 years
Improvement local control of chordomas according to PERCIST criteria
Time frame: 36 months
Rate of local control at 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Skull Base Chordoma
RecruitingObservational study
Exploration of Personalized Biomarkers During Neoadjuvant Radiation Therapy for Spinal and Sacral Chordoma
Chordoma of Spine, Chordoma of Skull Base
Active, not recruiting
High Dose Intensity Modulated Proton Radiation Treatment +/- Surgical Resection of Sarcomas of the Spine, Sacrum and Base of Skull
Chordoma of Spine, Chordoma of Sacrum
Active, not recruitingPhase 2
Proton Beam Therapy for Chordoma Patients
Chordoma
Active, not recruitingObservational study
Long-Term Longitudinal QoL in Patients Undergoing EEA
Pituitary Tumor, Meningioma
Recruiting
Hypofractionated Protontherapy in Chordomas and Chondrosarcomas of the Skull Base
Chordoma, Chondrosarcoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hamid MAMMAR, MD principal investigator
Institut Curie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Surgery, Protontherapy and 18F FAZA in people with Skull Base Chordoma and Vertebral Chordoma, run by Institut Curie at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement local control of chordomas according to RECIST criteria. (time frame: 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.