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

• Status: Recruiting
• Trial end date: 2024-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut Curie
• Treatments: Fluoroazomycin arabinoside

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.