RecruitingNot ApplicableNCT05861245

Hypofractionated Protontherapy in Chordomas and Chondrosarcomas of the Skull Base

Phase II Clinical Trial of Low-intervention Using Hypofractionated Protontherapy in Chordomas and Chondrosarcomas of the Skull Base

Sponsor

Quironsalud

Enrollment

20 participants

Start Date

May 24, 2023

Study Type

INTERVENTIONAL

Conditions

Chondrosarcoma Chordoma

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates hypofractionated proton therapy — a radiation treatment that delivers fewer but larger doses — for people with rare bone tumors (chordomas and chondrosarcomas) at the base of the skull. **You may be eligible if...** - You have a confirmed diagnosis of a chordoma or chondrosarcoma located at the skull base - You are in reasonably good physical condition (Karnofsky score 70% or higher) - Your tumor is within an appropriate size for the treatment approach being tested - Your radiation plan can adequately protect nearby critical structures like the brainstem and optic nerves - You have had MRI imaging that rules out pre-existing vascular problems **You may NOT be eligible if...** - Your tumor is too large or positioned in a way that makes safe radiation delivery impossible - You cannot tolerate the necessary radiation dose restrictions to protect vital structures near the skull base - You have not had the required imaging studies Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATION5-fraction hipofractionated protontheray

The therapeutic schemes that will be proposed to patients based on clinical criteria such as tumor size and relationship of the tumor with adjacent critical organs are: * For chordomas: 37.5 Gy in 5 consecutive sessions of 7.5 Gy per fraction. * For chondrosarcomas: 35 Gy in 5 consecutive sessions of 7 Gy per fraction.

RADIATION25-fraction hypofractionated proton therapy

The therapeutic regimens to be proposed to patients, based on clinical criteria such as tumor size and the relationship between the tumor and adjacent critical organs, are as follows: For chordomas: 67.5 Gy delivered in 27 consecutive fractions of 2.5 Gy per fraction to the high-risk volume, and 54 Gy delivered in 27 fractions of 2 Gy per fraction to the low-risk volume (integrated boost). For chondrosarcomas: 64.8 Gy delivered in 27 consecutive fractions of 2.4 Gy per fraction to the high-risk volume, and 54 Gy delivered in 27 fractions of 2 Gy per fraction to the low-risk volume (integrated boost).