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

IC 2014-16

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.

2016-07-22

2024-06-01

2024-12-01

Active (not recruiting)

Early phase I

64

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 64, 'type': 'ACTUAL'}}

2024-02-16