NCT04832620 Image Assisted Optimization of Proton Radiation Therapy in Chordomas and Chondrosarcomas
| NCT ID | NCT04832620 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Leiden University Medical Center |
| Condition | Bone Neoplasm of Vertebral Column |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2021-02-02 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 40 participants in total. It began in 2021-02-02 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Rationale: Chordomas and chondrosarcomas located in the axial skeleton are malignant neoplasms of bone. These tumors share the same clinical challenges, as the effect of the disease is more a function of their local aggressiveness than their tendency to metastasize (20% metastasize). The local aggressive behavior can cause debilitating morbidity and mortality by destruction of nearby located critical neurovascular structures. Imaging has, in addition to histopathology, a role in diagnosis and in guiding (neo)adjuvant and definitive treatment. Despite the low sensitivity to radiotherapy, proton radiotherapy has been successfully used as an adjunct to resection or as definitive treatment for aggressive chordomas and chondrosarcomas, making it a standard indication for proton therapy in the Netherlands. Chordomas and chondrosarcomas consist, especially after previous therapy, of non-viable and viable tumor components. Identification of these viable components by functional imaging is important to determine the effect of previous therapy, as change in total tumor volume occurs more than 200 days after change of functional imaging parameters. Objective: The main objective of this study is to determine if functional MRI parameters change within 6 months, and earlier than volumetric changes after start of proton beam therapy. This would allow timely differentiation between affected and unaffected (viable) tumor components, which can be used for therapy adjustment. Secondary objectives: Determine which set of parameters (PET-CT and secondary MRI) can predict clinical outcome (tumor specific mortality, development of metastases, morbidity secondary to tumor activity and morbidity secondary to treatment); determine what type of imaging can accurately identify viable tumor nodules relative to critical anatomical structures; improving understanding of relevance of changing imaging parameters by correlating these with resected tumor. Study design: Prospective cohort study Study population: LUMC patients diagnosed with primary or recurrent chordoma or chondrosarcoma in the axial skeleton. A number of 20 new patients per year is expected. Main study parameters: Volumetric and functional MR imaging parameters including permeability parameters. Secondary parameters are generated by PET-CT (SUV, MTV and TLG), MR (perfusion, permeability and diffusion), therapy (proton beam dose mapping, surgery) and clinical outcome. End points are disease specific survival, progression free survival (including development of metastases), side effects of treatment, and functional outcome (see CRF). In patients who are treated with surgical resection following neo-adjuvant therapy, the surgical specimen will be correlated with imaging findings. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Treatment and clinical management will not be affected in this study, thus the additional burden, risks, and benefits associated with participation in this study are minimal. Two extra MRI and one PET-CT examination will be planned during proton therapy.
Eligibility Criteria
Inclusion Criteria: * Histologically diagnosed with primary or recurrent chordoma or chondrosarcoma in the axial skeleton (clivus, spine and sacrum) * Accepted for standard proton beam therapy Exclusion Criteria: * Diagnosis other than chordoma or chondrosarcoma is made. * Patient refuses (parts) of the standard treatment protocol. * Patient refuses MRI due to claustrophobia. * Patient not suitable for MRI due to the presence of MRI incompatible implants. * Incapacitated patients. * Patient doesn't allow coded data to be used for analysis. * Patient is under 50 years of age. * Lesion size less than 1cm. * Patients with WHO 3 and higher.
Contact & Investigator
Stijn Krol, MD PhD
PRINCIPAL INVESTIGATOR
LUMC/HollandPTC
Frequently Asked Questions
Who can join the NCT04832620 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Bone Neoplasm of Vertebral Column. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04832620 currently recruiting?
Yes, NCT04832620 is actively recruiting participants. Contact the research team at A.D.G.Krol@lumc.nl for enrollment information.
Where is the NCT04832620 trial being conducted?
This trial is being conducted at Delft, Netherlands, Leiden, Netherlands.
Who is sponsoring the NCT04832620 clinical trial?
NCT04832620 is sponsored by Leiden University Medical Center. The principal investigator is Stijn Krol, MD PhD at LUMC/HollandPTC. The trial plans to enroll 40 participants.