CompletedPhase 2

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

France64 participantsStarted 2016-07-22

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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

What they're measuring

Improvement local control of chordomas according to RECIST criteria.

Timeframe: 36 months

Improvement local control of chordomas according to PERCIST criteria

Timeframe: 36 months

Trial details

NCT IDNCT02802969

SponsorInstitut Curie

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-28

View on ClinicalTrials.gov More Skull Base Chordoma trials