Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-24 @ 10:58 PM
NCT ID:
NCT02802969
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02802969
Study Brief:
Protocol Section:
NCT02802969