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New treatment option for Chordoma
Official title Hypofractionated Protontherapy in Chordomas and Chondrosarcomas of the Skull Base
ClinicalTrials.gov ID: NCT05861245
What this study is testing
- What it's testing
- 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.
- Time commitment: about 10 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- for 5 fractions:
- 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...
You likely can't join if
- 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.
See the full eligibility criteria
- for 5 fractions:
- 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...
- 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...
- 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.
- Tumor relationship to organs at risk allows compliance with the dose constraints required to receive hypofractionated proton therapy delivered in 27 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Madrid, Madrid, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 10 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Madrid, Madrid, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.