New proton therapy could shrink skull tumor treatment to just 5 days

NCT ID NCT05861245

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This phase II trial is testing a shorter course of proton therapy for people with chordomas or chondrosarcomas at the base of the skull. Instead of many sessions, patients receive radiation in just 5 consecutive days. The goal is to see if this approach is safe, controls tumor growth, and improves quality of life. The study is currently recruiting 20 participants.

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 (radiation) given in 5 sessions
What this could lead to
If successful, this could offer a shorter, more precise radiation treatment for skull base tumors, potentially reducing side effects and improving quality of life.
What could go wrong
This is a small early-phase trial with only 20 participants, so results may not apply to everyone. The treatment still carries risks of radiation side effects, and it is not a cure.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2023

Expected to finish

May 2033

An estimate. End dates often move.

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 for 5 fractions: * With a baseline classification on the Karnofsky performance status scale ≥ 70%. * With confirmed histological diagnosis of chordoma or chondrosarcoma of the skull base. * Who have signed the specific informed consent of the protocol, agreeing to participate in it. * Completion of magnetic resonance imaging with vascular assessment ruling out pre-existing vascular pathology (stenosis or atherosclerosis), including 3D T1 black-blood sequences, pre-contrast 3D TOF, 3D T2 with fat suppression, and perfusion sequences. * With a maximum tumor size of 50 cc. * Whose relationship to organs at risk (OARs) allows compliance with the necessary dose restrictions to receive hypofractionated proton therapy in 5 fractions. * Patients included in the study must meet dosimetric parameters that include: * Tumor CTV coverage of at least D95\>90%. * Correct compliance with the dose restrictions, at least in the nominal scenario, for critical organs (optic pathway, brain stem and spinal cord) according to the guidelines published and available in the literature: Dose contnstraints for 5 fractions: Optic Nerves: D0.03cc ≤ 25 GyRBE, V23.5 \< 0.5cc. Chiasm:D0.03cc ≤ 25 GyRBE, V23.5 \< 0.5cc. Brainstem:D0.03cc ≤ 31 GyRBE,V23 \< 0.5cc. Spinal Chord: D0.03cc ≤ 30 GyRBE, V23 \< 035cc. Right and left temporal lobes: D0.03 cc ≤ 35 GyRBE, V30 ≤ 5.5 cc. Inclusion Criteria for 25 fractions: * With a baseline classification on the Karnofsky performance status scale ≥ 70%. * With confirmed histological diagnosis of chordoma or chondrosarcoma of the skull base. * Who have signed the specific informed consent of the protocol, agreeing to participate in it. * Not considered candidates for the 5-fraction protocol due to tumor size exceeding 50 cc and/or the presence of vascular pathology (stenosis or atherosclerosis) identified on MRI with vascular sequences. * Tumor relationship to organs at risk allows compliance with the dose constraints required to receive hypofractionated proton therapy delivered in 27 fractions. * Patients included in the study must meet dosimetric parameters that include: * Tumor CTV coverage of at least D95\>90%. * Correct compliance with the dose restrictions, at least in the nominal scenario, for critical organs (optic pathway, brain stem and spinal cord) according to the guidelines published and available in the literature: Dose constraints for 25 fractions: Optic nerves: D0.03 cc ≤ 54.7 GyRBE. Optic chiasm: D0.03 cc ≤ 54.7 GyRBE. Brainstem: Surface: D0.03 cc ≤ 57.9 GyRBE. Core: D0.03 cc ≤ 54 GyRBE. Spinal cord: D0.03 cc ≤ 54 GyRBE. Right and left temporal lobes: V65 \< 1.7 cc, V60 ≤ 5.5 cc. Treatment planning with a minimum of 5 beams. In general, the use of a class solution with 6 beams will be proposed, including 2 lateral beams with gantry angles between 20° and 80°, depending on tumor location; 2 posterior oblique beams; and 2 anterior oblique beams. The latter four beams may include a couch rotation of at least 20° relative to the two lateral beams, with a minimum angular separation of at least 30° between ipsilateral oblique beams. Depending on individual patient characteristics, this class solution will be adapted to adjust specific gantry and couch angles for each field. If this solution is not feasible due to patient-specific characteristics (surgical constraints, tumor location or laterality, etc.), a 5-beam solution will be evaluated, including 2 posterior oblique beams and 2 anterior oblique beams, in addition to a coronal field with the couch at 270° and a gantry angle between 40° and 90° depending on tumor location, or other configurations that increase the number of ipsilateral oblique beams with a minimum inter-beam separation of at least 30°. Evaluation of Linear Energy Transfer (LET) and biological dose: For each treatment plan, the LET distribution obtained from the treatment planning system (TPS) will be evaluated, with particular attention to regions where LET values exceed 5 keV/μm, aiming to minimize such values. Equivalent biological dose distributions based on recognized models in the literature may also be assessed to support decision-making regarding the suitability of a given treatment plan Exclusion Criteria: * Patients with distant metastases. * Patients who have received previous irradiation in the same location. * Patients whose clinical or dosimetric characteristics do not meet the inclusion criteria. * Patients who are simultaneously participating in another study that may affect the results of this protocol.

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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.

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

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  3. A doctor treating you

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Contacts and locations

Locations

  • Centro de Protonterapia Quironsalud

    RECRUITING

    Madrid, Madrid, 28223, Spain

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