Proton Cranio-spinal Irradiation for Leptomeningeal Metastasis

Launched by UNIVERSITY OF AARHUS · Feb 16, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach called proton cranio-spinal irradiation for patients with leptomeningeal metastasis, a serious condition where cancer spreads to the membranes surrounding the brain and spinal cord. Current treatments are limited and often not effective, so researchers are exploring whether this new type of radiation therapy can help improve survival and control of the disease.

To be eligible for the trial, participants need to have confirmed leptomeningeal metastasis, be between the ages of 65 and 74, and be able to take care of most personal needs, with some assistance. They also need to have good blood health and agree to participate by giving consent. During the trial, participants will receive the new treatment and will be closely monitored to see how well it works. It's important to note that women who could become pregnant must either be past menopause or agree to use effective birth control during the study. If you or a loved one is facing this condition, this trial offers a potential new option for treatment that is currently not widely available.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Metastasis to the leptomeningeal space (LM) surrounding the brain and/ or spinal cord
• • Metastasis verified by MRI or CSF cytology
• • Karnofsky \>=60 (requiring some help, can take care of most personal requirements)
• • Adequate bone marrow function
• • Haemoglobin \> 5 mmol/l
• • Absolute neutrophil count \>1 10\^9/l
• • Platelet count \> 100 10\^9/l
• • Patient consent
• • Female subjects must either be of non-reproductive potential ( ≥ 60 years old, or with no menses for \>1 year without an alternative medical cause\], OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a pregnancy test within 2 weeks prior to starting treatment.
• • Patient at reproductive potential must agree to practice an effective contraceptive method.
• Exclusion Criteria:
• • • Previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances (Yang)
• • Patient with multiple, serious major neurologic deficits per physician/investigator assessment including encephalopathy
• • Patient with extensive systemic disease and without reasonable systemic treatment options
• • Patient who is unable to undergo MRI brain and spine with gadolinium contrast
• • Pregnant or lactating women.