Radiosurgery for Gliomas, Malignant

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Mayo Clinic in Florida, Jacksonville, FL
Gliomas, Malignant+1 More
Radiosurgery - Radiation
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether pre-operative radiosurgery is safe and effective for patients with high grade glioma.

See full description

Eligible Conditions

  • Gliomas, Malignant

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Gliomas, Malignant

Study Objectives

This trial is evaluating whether Radiosurgery will improve 1 primary outcome, 4 secondary outcomes, and 1 other outcome in patients with Gliomas, Malignant. Measurement will happen over the course of Up to 4 weeks postoperative radiotherapy.

At 12 months post-surgery
Overall survival
Radiographic tumor control
At first post radiation scan
Rate of pseudoprogression
Day 14
Tumor tissue evaluation of tumor changes
Week 4
Acute clinical toxicity
Proportion of patients experiencing any acute grade 3 or greater unplanned adverse event

Trial Safety

Safety Progress

1 of 3

Other trials for Gliomas, Malignant

Trial Design

2 Treatment Groups

Cohort B (surgery, radiation therapy, chemotherapy)
1 of 2
Cohort A (stereotactic biopsy, radiosurgery, surgery)
1 of 2
Active Control
Experimental Treatment

This trial requires 40 total participants across 2 different treatment groups

This trial involves 2 different treatments. Radiosurgery is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Cohort A (stereotactic biopsy, radiosurgery, surgery)Patients undergo MRI-guided stereotactic biopsy. Patients then undergo radiosurgery over 1 fraction. Within 14 days, patients undergo surgery. Within 4-6 weeks, 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.
Cohort B (surgery, radiation therapy, chemotherapy)Patients undergo surgery. Within 4-6 weeks, 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiosurgery
2005
Completed Phase 2
~160
Radiation Therapy
2005
Completed Phase 3
~7080
Temozolomide
FDA approved
Therapeutic Conventional Surgery
2014
Completed Phase 3
~8360

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at 12 months post-surgery
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly at 12 months post-surgery for reporting.

Closest Location

Mayo Clinic in Florida - Jacksonville, FL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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
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
No prior history of cranial radiotherapy
Eastern Cooperative Oncology Group (ECOG) performance status (PS) =< 2
Negative pregnancy test done =< 14 days prior to registration, for women of childbearing potential only
Ability to complete questionnaire(s) by themselves or with assistance
Provide written informed consent
Planning to receive adjuvant radiotherapy at enrolling institution
Willing to provide tissue and/or blood samples for correlative research purposes

Patient Q&A Section

What is radiosurgery?

"Radiosurgical techniques focused on tumour volume reduction using multiple beams covering a wide field of view can be applied to treat small tumors located in the optic nerve sheath. In our experience radiosurgery has been a safe and effective option for patients with optic nerve sheath meningiomas. However, larger series are needed to compare radiotherapy and radiosurgery in regard to long-term outcome and a better understanding of the dose-response relationship." - Anonymous Online Contributor

Unverified Answer

What does radiosurgery usually treat?

"Cerebral irradiation by Gamma Knife system is indicated in patients with tumors of the hypothalamus, optic nerve, chiasmatic region, third ventricle, and lateral recess of the fourth ventricle. For treatment of acoustic neuromas, Gamma Knife is routinely used. The radiosurgical method is highly effective and safe, and the results are satisfactory. However, further studies should be done." - Anonymous Online Contributor

Unverified Answer

Is radiosurgery typically used in combination with any other treatments?

"In our experience, radiosurgery is frequently combined with other treatments in some cases, particularly when surgery is impossible due to the location of the tumor. Radiosurgery helps maintain tumor control in patients otherwise suited for surgery, and it provides a reasonable alternative to surgery for some tumors unsuitable for surgery. Many institutions still consider radiosurgery necessary for some high-grade gliomas, especially those with a Ki-67 index of 50%. Surgical resection can be performed only if there are no contraindications, such as the tumor being close to the optic nerve, though certain cases may require partial surgical excision. Radiation therapy can be used alone or in combination with surgery." - Anonymous Online Contributor

Unverified Answer

What are common treatments for glioma?

"Almost all patients had recurrent disease. The end points of life-prolonging treatment were long time survival or remission. Survival after [brain tumor](https://www.withpower.com/clinical-trials/brain-tumor) operation was prolonged by chemotherapy but not radiotherapy." - Anonymous Online Contributor

Unverified Answer

What is glioma?

"GBM is a heterogeneous malignant neoplasm consisting of various grades of anaplastic astrocytoma, [oligodendroglioma](https://www.withpower.com/clinical-trials/oligodendroglioma), grade III anaplastic ependymoma, and grade IV anaplastic meningioma. Grade IV anaplastic meningioma is the most common primary brain tumor in adults, comprising approximately 15% of all primary brain tumors. Grade III anaplastic ependymoma is the second most common primary brain tumor in adults, comprising approximately 10 % of all primary brain tumors. Anaplastic ependymoma differs from glioma by its high tendency to infiltrate the subependymal tissue rather than the parenchyma." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for glioma?

"Results from a recent paper demonstrates that providers who want to enroll patients in clinical trials for glioma are faced with a number of hurdles that make clinical trial participation challenging. Results from a recent paper underscore the need for timely communication between oncologists and clinical trial coordinators regarding enrollment criteria and expectations for outcomes. Results from a recent paper suggest that clinicians can benefit from assessment of their attitudes toward clinical trials, and that medical educators and institutions can better support clinicians' participation in clinical trials." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of radiosurgery?

"The most common side effects were headache, nausea, and vomiting. Neurocognitive dysfunction occurred in about 3% of patients. It was mild or moderate in severity and often did not meet the criteria for a neuropsychological test. Results from a recent clinical trial suggest that radiotherapy via radiosurgery does not appear to cause significant neurocognitive dysfunction." - Anonymous Online Contributor

Unverified Answer

How quickly does glioma spread?

"Data from a recent study shows that even a highly malignant glioma tends to spread slowly. It suggests that the time between diagnosis and first operation should not be over two years, as is currently recommended by many organisations. However, we urge caution when evaluating the value of MRI scans performed more rapidly." - Anonymous Online Contributor

Unverified Answer

Can glioma be cured?

"No satisfactory therapeutic agents for glioma have been developed yet. There is no convincing evidence that any therapeutic agent will cure patients with glioma. The small percentage of patients who are cured by surgery or radiotherapy does not mean that the treatment is successful, but rather that the disease progresses too quickly to respond to the treatment." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of glioma?

"The data show that primary causes of glioma include: environmental factors such as cigarette smoking, radiation exposure, pesticides, industrial chemicals, etc., hereditary factors such as mutation in the genes coding for TP53 and IDH1, and inherited disorders such as Li-Fraumeni syndrome, Gorlin's syndrome, Cowden syndrome, Turcot syndrome, etc." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating glioma?

"There were several treatments which were tried out, but they could not bring about the desired effect and then most of them get discontinued. But some of these treatments still help, especially when they are given with surgery, radiotherapy or chemotherapeutic drugs. Most of these treatments bring about improvement in quality of life of patients. They also reduce the risk of dying. However they cannot cure the disease completely. Thus, it is necessary to find more effective therapies." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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