NCT05030298 Preoperative Radiosurgery for the Treatment of High Grade Glioma, NeoGlioma Trial
| NCT ID | NCT05030298 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Mayo Clinic |
| Condition | Malignant Glioma |
| Study Type | INTERVENTIONAL |
| Enrollment | 28 participants |
| Start Date | 2023-05-23 |
| Primary Completion | 2027-09-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 28 participants in total. It began in 2023-05-23 with a primary completion date of 2027-09-15.
⚠ 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
This phase I trial finds out the possible benefits and/or side effects of radiosurgery before surgery (preoperative) in treating patients with high grade glioma. Radiosurgery uses special equipment to position the patient and precisely give a single large dose of radiation to the tumor. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving pre-operative radiosurgery may improve the odds of brain tumor control and reduce treatment-related side effects.
Eligibility Criteria
Inclusion Criteria: * Age \>= 18 years * Clear clinical and radiographic evidence of primary high grade glioma (HGG) as judged by the Mayo multidisciplinary neuro-oncology team (World Health Organization \[WHO\] grade III-IV, including glioblastoma) regardless of IDH and MGMT status * Patients who underwent a previous biopsy confirming high grade glioma are eligible for enrollment * Planned neurosurgical resection of tumor * Judged to not be at risk of significant clinical risk (i.e. herniation) with radiation-induced edema prior to resection * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2 * Negative pregnancy test done =\< 14 days prior to registration, for women of childbearing potential only. Patients over 50 years of age who decline pregnancy testing are still eligible without a pregnancy test. * Ability to complete questionnaire(s) by themselves or with assistance * Provide written informed consent * Willing to receive adjuvant radiotherapy at enrolling institution at the time of registration * Willing to provide tissue and/or blood samples for correlative research purposes Exclusion Criteria: * Any of the following: * Pregnant women * Nursing women who are unwilling to cease during therapy * Men or women of childbearing potential who are unwilling to employ adequate contraception * Prior history of cranial radiotherapy * Unwillingness to participate in study * Investigator discretion that enrollment on the study would pose undo harm or risk to the patient * Non-MRI compatible implanted medical device * Use of systemic anti-cancer therapy within the previous 3 months * Medical contraindication to craniotomy and tumor resection * Pathologic confirmation of grade I-II glioma, brain metastasis, or other brain tumor * Note: Patients with a history of grade I-II glioma are eligible if they have only received surgery as treatment and now there is concern for transformation to grade III-IV tumor * Primary spinal cord glioma or primary brainstem glioma * Residual tumor of excessive volume or eloquent location per investigator discretion * Patients who are unwilling or unable to comply with study procedures
Contact & Investigator
Daniel M. Trifiletti, MD
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT05030298 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Malignant Glioma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05030298 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05030298 currently recruiting?
Yes, NCT05030298 is actively recruiting participants. Contact the research team at mayocliniccancerstudies@mayo.edu for enrollment information.
Where is the NCT05030298 trial being conducted?
This trial is being conducted at Phoenix, United States, Jacksonville, United States.
Who is sponsoring the NCT05030298 clinical trial?
NCT05030298 is sponsored by Mayo Clinic. The principal investigator is Daniel M. Trifiletti, MD at Mayo Clinic. The trial plans to enroll 28 participants.