Radiosurgery for Brain Cancer

Overseen By John Fiveash, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Must not be taking: Cytotoxic chemotherapy, TKIs

Disqualifiers: Pregnancy, Tumor > 4 cm, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1-3 weeks

180 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop taking cytotoxic chemotherapy within 3 days of treatment and hold certain TKIs (a type of cancer medication) at least 24 hours before treatment. There are no restrictions on the use of immunotherapy during treatment.

What data supports the effectiveness of the treatment Radiosurgery for brain cancer?

Radiosurgery is effective in treating brain metastases and malignant gliomas, with similar survival rates to traditional methods like surgery and whole brain radiotherapy, but with fewer complications and better quality of life. It can also treat tumors in hard-to-reach areas and multiple metastases, making it a preferred option for many patients. ^{1 2 3 4 5}

Is radiosurgery generally safe for treating brain conditions?

Radiosurgery is generally well tolerated, but there can be risks of neurotoxicity (damage to the nervous system) and radiation reactions, which vary in severity. Safety guidelines and checklists are used to minimize errors and complications, but more data is needed to determine the safest doses. ^{5 6 7 8 9}

How does the treatment radiosurgery differ from other treatments for brain cancer?

Radiosurgery is unique because it delivers a single, high dose of focused radiation directly to the brain tumor, minimizing damage to surrounding healthy tissue. This non-invasive treatment is particularly effective for inoperable or recurrent brain tumors and offers an alternative to traditional surgery with fewer complications. ^{1 10 11 12 13}

What is the purpose of this trial?

Radiosurgery is the use of a focal high dose of radiation therapy to ablate or kill a tumor. This trial will enroll patients with brain metastases 4 cm or less in greatest diameter and will compare 0mm margin to a 2mm margin for treatment.

Research Team

John A Fiveash, MD

Principal Investigator

The University of Alabama at Birmingham

Eligibility Criteria

This trial is for individuals with brain tumors that have spread (metastases) and are no larger than 4 cm. Specific eligibility details aren't provided, but typically participants must meet certain health standards and not have conditions that could interfere with the study.

Inclusion Criteria

Stated willingness to comply with all study procedures and availability for the duration of the study

My brain cancer has not needed more treatment.

I am 19 years old or older.

Exclusion Criteria

My treatment plan may target more than 20 cancer areas after review.

I've had focused radiation before and may need it again.

Inability to have MRI imaging

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive radiosurgery treatment with either a 0mm or 2mm margin for brain metastases

1-3 weeks

1 visit (in-person)

Follow-up

Participants are monitored for tumor control and toxicity over a 12-month period

12 months

Regular visits (frequency not specified)

Treatment Details

Interventions

• Radiosurgery

Trial Overview The trial is testing the effectiveness of radiosurgery, a high-dose radiation treatment aimed at destroying tumors in the brain. It compares two approaches: one uses no extra space around the tumor (0mm margin), while the other includes a small buffer zone (2mm margin).

Participant Groups

Group I: 0mm margin Active Control 1 Intervention

For each patient two radiation treatment plans will be created. One will have 0 mm margin for the planning target volume. Tumors will be prescribed based upon the maximum diameter of the largest tumor and location at the discretion of the treating radiation oncologist with the following guidance: \< 2.0 cm diameter 16-20 Gy 2.0-4.0 cm diameter 3 fractions of 9 Gy for total 27 Gy.

Group II: 2mm margin Active Control 1 Intervention

For each patient two radiation treatment plans will be created. One will be 2 mm margin for the planning target volume. Tumors will be prescribed based upon the maximum diameter of the largest tumor and location at the discretion of the treating radiation oncologist with the following guidance: \< 2.0 cm diameter 16-20 Gy 2.0-4.0 cm diameter 3 fractions of 9 Gy for total 27 Gy.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Findings from Research

Radiosurgery effectively treats small intracranial tumors and arteriovenous malformations (AVMs) using precise radiation delivery, with applications for both malignant tumors (like brain metastases and gliomas) and benign tumors (such as meningiomas and acoustic neuromas).

Most patients experience clinical improvement with radiosurgery, and it generally results in less morbidity compared to traditional surgical resection, despite the potential for complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical uses of radiosurgery. Chang, SD., Adler, JR., Hancock, SL.[2006]

Stereotactic radiosurgery (SRS) was safely administered to 30 patients with malignant gliomas after standard radiotherapy, showing no significant acute or late toxicity, which suggests it is a feasible option for dose escalation in treatment.

The study reported a median survival of 13.9 months, with 1- and 2-year disease-specific survival rates of 57% and 25%, respectively, indicating that while SRS can be effective, further research is needed to fully understand its impact on long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic radiosurgery as an adjunct to surgery and external beam radiotherapy in the treatment of patients with malignant gliomas. Gannett, D., Stea, B., Lulu, B., et al.[2022]

The implementation of a safety checklist for Gamma Knife stereotactic radiosurgery (SRS) over 1500 procedures in 8 years has resulted in no reported human errors, highlighting its effectiveness in enhancing safety.

The checklist addresses specific indications for irradiating tissue volumes and functional disorders, promoting a zero-tolerance approach to errors and fostering multidisciplinary cooperation in neurosurgical practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lausanne checklist for safe stereotactic radiosurgery. Tuleasca, C., Zeverino, M., Patin, D., et al.[2020]

Moderately dosed stereotactic radiosurgery (SRS) for one to four brain metastases showed a median overall survival of 7.5 months, with high local brain control rates of 87% at 6 months and 79% at 12 months, indicating its efficacy in treating limited brain metastases.

The study suggests that initial SRS alone can be a safe treatment option, as only 22% of patients required additional whole-brain radiotherapy, and significant predictors of survival included the time between the primary diagnosis and brain metastases, as well as the volume of the treated metastasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome of moderately dosed radiosurgery for limited brain metastases. Report of a single-center experience. Meisner, J., Meyer, A., Polivka, B., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Clinical uses of radiosurgery. [2006]

2. United States pubmed.ncbi.nlm.nih.gov

Stereotactic radiosurgery as an adjunct to surgery and external beam radiotherapy in the treatment of patients with malignant gliomas. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Current status and optimal use of radiosurgery. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Radiosurgery for the treatment of brain metastases. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

The use of stereotactic radiosurgery to treat neurological tumors. [2004]

6. United States pubmed.ncbi.nlm.nih.gov

Neurotoxicity of Radiosurgery. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

The influence of volume on the tolerance of the brain to radiosurgery. [2022]

8. Austria pubmed.ncbi.nlm.nih.gov

Lausanne checklist for safe stereotactic radiosurgery. [2020]

9. Germany pubmed.ncbi.nlm.nih.gov

Outcome of moderately dosed radiosurgery for limited brain metastases. Report of a single-center experience. [2021]

10. Germany pubmed.ncbi.nlm.nih.gov

Role of radiosurgery in the management of central nervous system metastases. [2019]

11. France pubmed.ncbi.nlm.nih.gov

[Radiosurgery of brain metastasis]. [2019]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Radiobiology, principle and technique of radiosurgery. [2019]

13. Canada pubmed.ncbi.nlm.nih.gov

Clinical indications for the radiosurgical treatment of brain tumors. [2007]