Chordomas of the skull base, spine and sacrum
Conditions
Interventions
Product Name: 1-(5- [18F]-fluoro-5-desoxy-a-arabinofuranosyl)-2-nitroimidazole
Product Code: NA
Pharmaceutical Form: Concentrate for solution for injection
Sponsors
INSTITUT CURIE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Typical chordomas and chondroid chordomas of the skull base, spine and sacral region with Incomplete and/or split up exerese ( non mono-bloc exerese) - Patient for whom an additonal prothontherapy treatment is relevant - Age= 18 years old, KI > 80%, life expectancy > 3years (lower limit), - ECOG performance status 0 to 2 - satisfying biological functions 14 days before inclusion : a. Haemoglobin = 9 g/dL b. Neutrophils = 1500/mm3 c. Platelets = 100 000/mm3 d. ASAT, ALAT, GGT, PAL = 1.5 N, bilirubine = 40 µmol/L, LDH = 1.5 N e. Creatininemia =65 years) yes F.1.3.1 Number of subjects for this age range 64
Exclusion criteria
Exclusion criteria: - Dedifferentiated chordomas, chondrosarcomas, chrodomas of the sacral region with complete and mono-bloc exerese. - Metastatic patient - Contraindications to radiotherapy - Contraindications to PET/CT examinations [18F]FDG PET/CT and [18]FAZA PET/CT - Associated pathology likely to prevent the patient from receiving treatment, - History of cancer (except cutaneous basocellular epithelioma or epithelioma of the uterine cervix) having recurred in the 5 years preceding entry in the trial, - Patient already included in another therapeutic trial with an experimental medication - history of brain radiation therapy, or base of the skull or spinal segments to be treated - incompatible treatment with the inclusion in the study (oxygen therapy, EPO, anti-vascular treatments, anti-angiogenic tretaments) - Pregnancy, or possibility of pregnancy, or 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Improvement of local control with proton beam irradiation, optimized on the hypoxic component of the chordoma, as determined by PET/CT [18F]FAZA.;Secondary Objective: -Toxicity evaluation, - Evaluation of metabolic response to treatment through PET/CT exams with [18F]FDG and [18F]FAZA with regards to semi-quatitative criterias of standard uptake value (SUV) measurements and PERCIST criterias. - Evaluation of overall survival, - Correlation between the hypoxic zones (distribution of [18F]FAZA) and the different biological factors (HIF, CA IX, CA XII, MCT1, MCT4, CD147, GLUT, Bnip3) - Correlation between glucose metabolism [18F]FDG PET/CT and the hypoxic component [18F]FAZA PET/CT - constitutional and tumoral genetic sequencing - Development of an animal model (Interspecies transplant);Primary end point(s): Local control according to RECIST criteria. ;Timepoint(s) of evaluation of this end point: 36 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Toxicity evaluation according to NCI CTC-AE version 4. - Evaluation of metabolic response to treatment through PET/CT exams with [18F]FDG and [18F]FAZA with regards to semi-quatitative criterias of standard uptake value (SUV) measurements and PERCIST criterias. - Evaluation of overall survival. - Correlation between the hypoxic zones (distribution of [18F]FAZA) and the different biological factors (HIF, CA IX, CA XII, MCT1, MCT4, CD147, GLUT, Bnip3) - Correlation between glucose metabolism [18F]FDG PET/CT and the hypoxic component [18F]FAZA PET/CT - constitutional and tumoral genetic sequencing - Development of an animal model (Interspecies transplant);Timepoint(s) of evaluation of this end point: 36 months | — |
Countries
France
Contacts
Public ContactGASTRIN Chrystelle
INSTITUT CURIE
Outcome results
None listed