Preoperative Radiosurgery in High Grade Glioma: A Phase I Clinical Trial: The NeoGlioma Study

Who is this study for? Patients with high grade glioma
What treatments are being studied? Radiation Therapy+Radiosurgery+Stereotactic Biopsy+Temozolomide+Therapeutic Conventional Surgery+Tumor Treating Fields Therapy
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure, Drug, Radiation
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Arizona
Mayo Clinic in Arizona
RECRUITING
Phoenix
Florida
Mayo Clinic in Florida
RECRUITING
Jacksonville
Contact Information
Primary
Clinical Trials Referral Office
mayocliniccancerstudies@mayo.edu
855-776-0015
Time Frame
Start Date: 2023-05-23
Estimated Completion Date: 2027-09-15
Participants
Target number of participants: 28
Treatments
Experimental: Treatment (stereotactic biopsy, radiosurgery, surgery)
Patients undergo MRI-guided stereotactic biopsy. Within 14 days of registration, patients undergo either standard of care surgery or radiosurgery in 1 fraction. Within 14 days, patients who underwent radiosurgery then undergo surgery. Within 4-6 weeks, all patients then receive standard of care radiation therapy over 30 fraction and temozolomide daily with or without TTF at the discretion of the treating neuro-oncologist. Additionally, patients undergo MRI and blood sample collection and optional biopsy throughout the study.
Related Therapeutic Areas
Sponsors
Leads: Mayo Clinic

This content was sourced from clinicaltrials.gov