Actively Recruiting
Hypofractionated Protontherapy in Chordomas and Chondrosarcomas of the Skull Base
Led by Quironsalud · Updated on 2026-01-23
20
Participants Needed
1
Research Sites
521 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The project is planned as a phase II clinical trial with a low level of intervention, for the prospective evaluation of the clinical results of radical or adjuvant treatment by proton therapy in chordomas and chondrosarcomas of the skull base using hypofractionation schemes in 5 fractions, with the aim of consolidating the scientific evidence that exists with high-precision techniques with photons, increasing this evidence by adapting this treatment scheme to the proton technique. In addition, a cross-sectional prospective evaluation of the quality parameters of the dosimetry of hypofractionated proton therapy and an evaluation of the quality of life of these patients will be carried out. * Primary Objective 1. \- Toxicity according to CTCAE-v5 criteria 2. \- Local control determined by Magnetic Resonance with Gadolinium. * Secondary Objectives 1. To evaluate the quality of life of the patients, 3 months after the end of the treatment, using a specific questionnaire. 2. To evaluate the dosimetric benefits using techniques that allow an improvement in the dose gradient, improving the coverage of the CTV (Clinical Tumor Volume) and decreasing the dose in surrounding risk organs.
CONDITIONS
Official Title
Hypofractionated Protontherapy in Chordomas and Chondrosarcomas of the Skull Base
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Karnofsky performance status of 70% or higher
- Histological confirmation of chordoma or chondrosarcoma at the skull base
- Signed informed consent to participate in the study
- Completed MRI with vascular assessment ruling out vascular pathology
- Tumor size 50 cc or smaller for 5-fraction treatment eligibility
- Tumor location and size allow meeting the dose restrictions for proton therapy
- Tumor Clinical Tumor Volume (CTV) coverage of at least D95>90%
- Compliance with dose constraints for critical organs (optic nerves, chiasm, brainstem, spinal cord, temporal lobes) as per protocol
- For 25-fraction treatment: patients not eligible for 5-fraction protocol due to tumor size over 50 cc or vascular pathology
- Treatment planning using at least 5 beams with specified beam arrangements
You will not qualify if you...
- Presence of distant metastases
- Previous irradiation in the same location
- Clinical or dosimetric characteristics not meeting inclusion criteria
- Participation in another study that could affect this protocol's results
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Centro de Protonterapia Quironsalud
Madrid, Madrid, Spain, 28223
Actively Recruiting
Research Team
M
Morena Sallabanda, MD PhD
CONTACT
J
Juan Antonio Vera, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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