Hypofractionated Protontherapy in Chordomas and Chondrosarcomas of the Skull Base

NCT05861245 | Recruiting

• 1 other identifier: PIC128-22_QUIRON
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

1. 1.\- Toxicity according to CTCAE-v5 criteria
2. 2.\- Local control determined by Magnetic Resonance with Gadolinium.
3. 3.Secondary Objectives
4. 4.To evaluate the quality of life of the patients, 3 months after the end of the treatment, using a specific questionnaire.
5. 5.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

Keywords

Skull base; Protontherapy; Hypofractionation; Chordoma; Chondrosarcoma

Outcome Measures

Primary Outcomes (3)

• 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.

  0 - 3 months

• 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.

  3 months - 10 years

• 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%).

  1 - 10 years

Secondary Outcomes (3)

• Quality of life after treatment - QLQ-C30

  3 months

• Quality of life after treatmenT- QLQ-BN20

  3 months

• Dosimetric benefits

  3 months

Study Arms (2)

5 fractions

EXPERIMENTAL

* Patients \> 18 years old. * With a baseline classification on the Karnofsky performance status scale ≥ 70%. * With confirmed histological diagnosis of chordoma or chondrosarcoma of the skull base. * With a maximum tumor size of 50 cc. * With a magnetic resonance imaging (MRI) t ruling out pre-existing vascular pathology (stenosis or atherosclerosis). * Whose relationship to organs at risk (OARs) allows compliance with the necessary dose restrictions to receive hypofractionated proton therapy in 5 fractions. Patients included in the study must meet dosimetric parameters that include: * Clinical Target Volume (CTV) coverage of at least D95\>90%. * Correct compliance with the dose restrictions, at least in the nominal scenario, for critical organs (optic pathway, brain stem, spinal cord and temporal lobes) according to the guidelines published and available in the literature.

Radiation: 5-fraction hipofractionated protontheray

25 fractions

EXPERIMENTAL

* Patients \> 18 years old. * With a baseline classification on the Karnofsky performance status scale ≥ 70%. * With confirmed histological diagnosis of chordoma or chondrosarcoma of the skull base. * Not considered candidates for the 5-fraction protocol due to tumor size exceeding 5 cc and/or the presence of vascular pathology identified on MRI with vascular sequences. * Tumor relationship to organs at risk allows compliance with the dose constraints required to receive hypofractionated proton therapy delivered in 27 fractions.

Radiation: 25-fraction hypofractionated proton therapy

Interventions

25-fraction hypofractionated proton therapy RADIATION

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).

25 fractions

5-fraction hipofractionated protontheray RADIATION

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.

5 fractions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• With a maximum tumor size of 50 cc.
• Whose relationship to organs at risk (OARs) allows compliance with the necessary dose restrictions to receive hypofractionated proton therapy in 5 fractions.
• Patients included in the study must meet dosimetric parameters that include:
• Tumor CTV coverage of at least D95\>90%.
• Correct compliance with the dose restrictions, at least in the nominal scenario, for critical organs (optic pathway, brain stem and spinal cord) according to the guidelines published and available in the literature:
• Dose contnstraints for 5 fractions:
• Optic Nerves: D0.03cc ≤ 25 GyRBE, V23.5 \< 0.5cc. Chiasm:D0.03cc ≤ 25 GyRBE, V23.5 \< 0.5cc. Brainstem:D0.03cc ≤ 31 GyRBE,V23 \< 0.5cc. Spinal Chord: D0.03cc ≤ 30 GyRBE, V23 \< 035cc. Right and left temporal lobes: D0.03 cc ≤ 35 GyRBE, V30 ≤ 5.5 cc.
• 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.
• Not considered candidates for the 5-fraction protocol due to tumor size exceeding 50 cc and/or the presence of vascular pathology (stenosis or atherosclerosis) identified on MRI with vascular sequences.

You may not qualify if:

• Patients with distant metastases.
• Patients who have received previous irradiation in the same location.
• Patients who are simultaneously participating in another study that may affect the results of this protocol.

Sponsors & Collaborators

• Quironsalud: lead

Study Sites (1)

Centro de Protonterapia Quironsalud

Madrid, Madrid, 28223, Spain

RECRUITING

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MeSH Terms

Conditions

Chordoma; Chondrosarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Sarcoma

Central Study Contacts

Morena Sallabanda, MD PhD

CONTACT

0034 917226716; msallabanda@quironsalud.es

Juan Antonio Vera, PhD

CONTACT

0034 917226716; juan.vera@quironsalud.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 26, 2023
• First Posted: May 16, 2023
• Study Start: May 24, 2023
• Primary Completion (Estimated): May 24, 2027
• Study Completion (Estimated): May 24, 2033
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

ES (1)