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Recruiting NCT05030298

Preoperative Radiosurgery for the Treatment of High Grade Glioma, NeoGlioma Trial

Conditions: Malignant Glioma

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 28
Sponsor: Mayo Clinic

Location: Mayo Clinic in Arizona Phoenix Arizona

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05030298). StuddyBuddy aggregates publicly available trial information.