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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
5-fraction hipofractionated protontheray
RadiationThe 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.
25-fraction hypofractionated proton therapy
RadiationThe 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).
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: 5 fractionsExperimental treatment 1 intervention
Group B: 25 fractionsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Acute treatment tolerance
To evaluate acute toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) scale, of the implementation of hypofractionation schemes in the treatment with protontherapy of skull base chordomas and chondrosarcomas.
Time frame
0 - 3 months2
Chronic treatment tolerance
To evaluate chronic toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) scale, of the implementation of hypofractionation schemes in the treatment with protontherapy of skull base chordomas and chondrosarcomas.
Time frame
3 months - 10 years3
Local control
To evaluate the clinical impact in terms of local control based on the radiological findings by MRI with gadolinium (considering progression to an increase in tumor volume \> 10%).
Time frame
1 - 10 yearsSecondary outcomes
1
Quality of life after treatment - QLQ-C30
To evaluate the quality of life of the patients included in the study, for this, in a period of 3 months after the end of treatment, the patients will be summoned in person at the center to carry out the questionnaire of quality of life for cancer patients EORTC QLQ-C30.
Time frame
3 months2
Quality of life after treatmenT- QLQ-BN20
To evaluate the quality of life of the patients included in the study, for this, in a period of 3 months after the end of treatment, the patients will be summoned in person at the center to carry out the questionnaire of quality of life for cancer patients with central nervous system tumors, EORTC QLQ-BN20.
Time frame
3 months3
Dosimetric benefits
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. For this, apertures will be used whenever necessary to reduce the dose in surrounding tissues and the pre-treatment dosimetric distributions will be verified.
Time frame
3 monthsSponsors and contacts
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Source ClinicalTrials.gov