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Hypofractionated Protontherapy in Chordomas and Chondrosarcomas of the Skull Base

NCT05861245 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-01-23

No results posted yet for this study

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.

Conditions

  • Chordoma
  • Chondrosarcoma

Interventions

RADIATION

5-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.

RADIATION

25-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).

Sponsors & Collaborators

  • Quironsalud

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-24
Primary Completion
2027-05-24
Completion
2033-05-24

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05861245 on ClinicalTrials.gov