Health TrialsbyHealthPanel

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

ConditionMalignant Glioma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • Radiation Therapy

    Radiation

    Undergo radiation therapy

  • Radiosurgery

    Radiation

    Undergo radiosurgery

  • Stereotactic Biopsy

    Procedure/Surgery

    Undergo MRI-guided stereotactic biopsy

  • Temozolomide

    Drug

    Drug

  • Tumor Treating Fields Therapy

    Procedure/Surgery

    Undergo TTF

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Biopsy

    Procedure/Surgery

    Undergo biopsy

  • Therapeutic Conventional Surgery

    Procedure/Surgery

    Undergo surgery

Treatment groups

28 Participants
are divided into 1 treatment group
Group A: Treatment (stereotactic biopsy, radiosurgery, surgery)Experimental treatment 9 interventions

Trial outcomes

Primary outcomes

1

Proportion of patients experiencing any acute grade 3 or greater unplanned adverse event

Assessed per Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0. The toxicity rate will be estimated using a binomial estimator and a one-sided 95% confidence interval (CI) of the rate will be computed with normal approximation.

Time frame
Up to 4 weeks postoperative radiotherapy
2

Acute clinical toxicity

Assessed per CTCAE v5.0. The maximum grade for each type of acute adverse events will be recorded for each patient. Data will be summarized as frequencies and relative frequencies by treatment arm. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. Rates will be compared between arms using chi-squared tests.

Time frame
Up to 4 weeks postoperative radiotherapy
3

Maximum tolerated dose (MTD) of preoperative radiosurgery

After the trial is completed, the MTD will be based on isotonic regression. The dose for which the isotonic estimate of the toxicity rate is closest to the target toxicity rate will be selected as the MTD. If there are ties, the higher dose level will be selected when the isotonic estimate is lower than the target toxicity rate; and the lower dose level will be selected when the isotonic estimate is greater than or equal to the target toxicity rate.

Time frame
Up to 4 weeks postoperative radiotherapy

Secondary outcomes

1

Radiographic tumor control

Assessed per Response Assessment in Neuro-Oncology (RANO) criteria. The cumulative incidence of radiographic tumor recurrence will be estimated using a competing risks method (Gooley et al.). The competing risks will be death.

Time frame
At 12 months post-surgery
2

Rate of pseudoprogression

Assessed per RANO criteria. Data will be summarized as frequencies and relative frequencies overall and by treatment dose. Additionally, the relationship of the pseudoprogression(s) to the study treatment will be taken into consideration.

Time frame
At first post radiation scan
3

Overall survival

Overall survival (OS) is defined as the time from study enrollment to death by any cause. Will be estimated with a Kaplan-Meier estimator and curve for patients treated with preoperative radiosurgery. Estimates will be given for specific time points along with 95% CIs.

Time frame
At 12 months post-surgery

Other outcomes

1

Tumor tissue evaluation of tumor changes

Any excess tissue recovered from the surgical specimen (after standard of care pathologic evaluation) will undergo a series of advanced testing, potentially including but not limited to evaluation of the tumor repair pathways triggered by radiation, tumor vascular changes, tumor microenvironment immune profiling, cell cultures, and the creation of orthotopic xenograft models for future study. Analysis will be completed outside the scope of this protocol.

Time frame
Up to 14 days Post-radiosurgery

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
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