Hypofractionated Protontherapy in Chordomas and Chondrosarcomas of the Skull Base
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorQuironsalud
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- 5-fraction hipofractionated protontheray
- 25-fraction hypofractionated proton therapy
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov