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

NCT02802969 | Completed Phase 2 DMC

• 1 other identifier: IC 2014-16
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Skull Base Chordoma; Vertebral Chordoma

Outcome Measures

Primary Outcomes (2)

• Improvement local control of chordomas according to RECIST criteria.

  Rate of local control at 3 years

  36 months

• Improvement local control of chordomas according to PERCIST criteria

  Rate of local control at 3 years

  36 months

Study Arms (1)

[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.

Procedure: Surgery; Radiation: Protontherapy; Drug: 18F FAZA

Interventions

Surgery PROCEDURE

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.

[18F]FAZA PET/CT

Protontherapy RADIATION

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]FAZA PET/CT

18F FAZA DRUG

FAZA PET/CT, in order to target the hypoxic zones

Also known as: 18F FLUOROAZOMYCIN-ARABINOFURANOSIDE

[18F]FAZA PET/CT

Eligibility Criteria

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

You may qualify if:

• 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
• Haemoglobin ≥ 9 g/dL
• 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
• Patient covered by health insurance
• Patient provided with information and signature of informed consent.

You may not qualify if:

• 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,
• 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.

Sponsors & Collaborators

• Institut Curie: lead

Study Sites (1)

Institut Curie - Hôpital René Huguenin

Saint-Cloud, Île-de-France Region, 92210, France

Location

MeSH Terms

Interventions

Surgical Procedures, Operative; fluoroazomycin arabinoside

Study Officials

• Hamid MAMMAR, MD

  Institut Curie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2016
• First Posted: June 16, 2016
• Study Start: July 22, 2016
• Primary Completion: November 28, 2024
• Study Completion: November 28, 2024
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• 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).

Locations

FR (1)