Hypofractionated Protontherapy in Chordomas and Chondrosarcomas of the Skull Base

Launched by QUIRONSALUD · May 15, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to treat specific types of tumors called chordomas and chondrosarcomas, which occur at the base of the skull. Researchers want to see how effective and safe a treatment called hypofractionated proton therapy is. This method delivers radiation in fewer, larger doses (five in total) to precisely target the tumor while minimizing damage to nearby healthy tissues. The trial also aims to evaluate how this treatment affects patients' quality of life and the accuracy of the radiation doses delivered.

To participate in this study, candidates must be adults aged 65 to 74 with a confirmed diagnosis of chordoma or chondrosarcoma and a relatively good performance status, meaning they can carry out daily activities with minimal assistance. Participants will need to meet certain medical criteria, such as having a tumor size of no more than 50 cc and ensuring that nearby critical organs can safely receive the treatment. Throughout the trial, patients will be monitored for side effects, and their quality of life will be assessed three months after finishing treatment. Overall, this study aims to gather important information that could help improve the care for patients with these specific tumors.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• • 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.
• Exclusion Criteria:
• • 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.