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New Scan-Guided proton therapy aims to stop rare bone tumors

NCT ID NCT02802969

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

64 people

The number who actually took part.

Started

Jul 2016

Finished

Nov 2024

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Institut Curie - Hôpital René Huguenin

    Saint-Cloud, Île-de-France Region, 92210, France

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