New Scan-Guided proton therapy aims to stop rare bone tumors
NCT ID NCT02802969
First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This study tested whether using a special PET scan (FAZA) to find oxygen-starved (hypoxic) tumor cells can help guide proton therapy for chordomas of the skull base, spine, or sacrum. 64 adults who had surgery or were getting radiation received a higher radiation dose to the hypoxic areas. The goal was to improve local tumor control at 3 years.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- proton therapy
- What this could lead to
- If successful, this approach could improve local control of chordomas by better targeting resistant tumor cells.
- What could go wrong
- This is a small Phase 2 trial with 64 participants, so results may not apply broadly. The technique is complex and may not significantly improve outcomes over standard therapy.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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64 people
The number who actually took part.
- Started
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Jul 2016
- Finished
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Nov 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Institut Curie - Hôpital René Huguenin
Saint-Cloud, Île-de-France Region, 92210, France
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