CLINICAL TRIAL

radiosurgery for Neoplasm Metastasis

Metastatic
Recruiting · 18+ · All Sexes · Cleveland, OH

Neoadjuvant Radiosurgery for Resectable Brain Metastases: Phase I/II Study

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About the trial for Neoplasm Metastasis

Eligible Conditions
Neoplasm Metastasis · Tumors Metastatic to Brain · Brain Neoplasms

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 not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
radiosurgery
RADIATION
quality-of-life assessment
PROCEDURE
therapeutic conventional surgery
PROCEDURE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
radiosurgery
2009
N/A
~70
quality-of-life assessment
2012
Completed Phase 3
~2780
therapeutic conventional surgery
2003
Completed Phase 3
~11930

Eligibility

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Magnetic resonance imaging (MRI) evidence of 1-4 brain metastases, with at least one lesion > 20 mm and ≤ 50 mm in maximal diameter and determined to be appropriate for SRS and gross total resection; all other brain metastases are appropriate for SRS
Have a prior histologic diagnosis of cancer other than small cell lung cancer, lymphoma, and germ cell histologies
Patient can have prior SRS to lesions other than the one planned for neoadjuvant SRS and resection
Patient must have a Karnofsky performance score of ≥ 70
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 3 years
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to 3 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 3 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether radiosurgery will improve 2 primary outcomes and 3 secondary outcomes in patients with Neoplasm Metastasis. Measurement will happen over the course of Day 0.

Maximum tolerated dose (MTD)
DAY 0
MTD of radiosurgery determined by dose-limiting toxicities graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0 (Phase I)
DAY 0
Proportion of participants with distant brain failure
UP TO 3 YEARS
Rate of distant brain failure, defined as progression of brain metastases outside of the brain metastasis treated on study. The Kaplan-Meier method will be used.
UP TO 3 YEARS
Rate of radiation necrosis/steroid dependency
UP TO 3 YEARS
Rate of radiation necrosis/steroid dependency
UP TO 3 YEARS
Rate of salvage treatment
UP TO 3 YEARS
Number of patients that have any salvage treatment, including surgery, stereotactic radiosurgery (SRS), or whole brain radiation therapy (WBRT)
UP TO 3 YEARS
Proportion of participants without local failure (Phase II)
UP TO 3 YEARS
Local control of brain metastases, as measured by proportion of participants without local failure (Local failure is tumor progression of the metastasis treated on the study) (Phase II) The Kaplan-Meier method will be used.
UP TO 3 YEARS

Patient Q & A Section

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

Does radiosurgery improve quality of life for those with tumors metastatic to brain?

Radiosurgical treatment of tumors metastatic to brain is associated with meaningful and sustained improvements (p <.01), in most measures, of a patient's health-related quality of life.

Anonymous Patient Answer

What is tumors metastatic to brain?

Metastases of solid tumors to the brain are frequent and often present late, but are treatable with surgical resection or radiotherapy as adjuvant. A specific treatment for the brain is not available but the best treatment for patients with metastases is multidisciplinary treatment.

Anonymous Patient Answer

Can tumors metastatic to brain be cured?

There is no curative treatment for metastatic tumor in brain. There are significant limitations or side effects of standard chemotherapy that result in severe cognitive and psychiatric impairment. At the same time, high brain energy metabolism and increased immune system activity must be carefully assessed from an ethical point of view, considering the severity of their symptoms.

Anonymous Patient Answer

What causes tumors metastatic to brain?

A very small minority of brain metastases are purely primary, which implies some metastatic pathway other than through bronchial spread. The likelihood of having brain nodularity is greater in tumors with more multifocal metastases, tumors of more solid histologic subtypes, tumors arising in the hypothalamus, and tumors that are diagnosed in earlier stages of disease.

Anonymous Patient Answer

What are the signs of tumors metastatic to brain?

In our study there is no significant difference between intracranial and extracranial metastases and the presence of brain metastases do not increase the risk of death from extracranial metastatic tumors. Moreover, the presence of brain metastases does not produce functional manifestations from other organ metastatic tumors.

Anonymous Patient Answer

What are common treatments for tumors metastatic to brain?

Staging, surgical, and other supportive measures are used to manage metastatic [brain tumor](https://www.withpower.com/clinical-trials/brain-tumor)s. Surgery often occurs in combination with chemotherapy, radiation, and/or hormonal therapy. Radiation therapy is used in some cases of brain metastases. Immunotherapy and/or targeted chemotherapeutics are used in a limited number of metastatic brain tumor cases. Glioma is a heterogenous group with varying histology, tumoral grade, and prognosis. Treatment modalities, including surgery, radiation radiochemotherapy (recompression and chemotherapy), anti-vascular endothelial growth factor therapy and gliopeptide chemotherapy are used in most cases to minimize secondary tumor burden.

Anonymous Patient Answer

How many people get tumors metastatic to brain a year in the United States?

Patients with brain metastases or a family history of cancer can be easily and accurately identified. To assess the appropriateness of a new treatment option or to identify more people with CNS metastases, an international panel is needed. With more detailed patient risk assessment, a standardized follow-up schedule may also become more effective.

Anonymous Patient Answer

Does tumors metastatic to brain run in families?

We find that cancer in general is a highly heritable disease, as is metastatic cancer in particular. Tumors in the central nervous system are metastatic tumors that are extremely rare and generally have poor prognoses. Further work is needed to clarify whether the genetic and environmental factors regulating metastatic disease in central nervous system tumors are distinct from those that predispose general cancer susceptibility, to define the nature of genetic and environmental risk for metastatic brain neoplasms, and to identify the underlying mechanisms of the genetic heritability of metastatic brain tumorigenesis.

Anonymous Patient Answer

What are the common side effects of radiosurgery?

We have studied the radiokinesis (radio tolerance response) after SSRS of the whole brain. Results show that the tolerance response is less pronounced than expected and may be associated with increased radiosensitization, which is not considered a side effect of radiosurgery.

Anonymous Patient Answer

What is the average age someone gets tumors metastatic to brain?

[At the Massachusetts Tumor Center] mean brain metastasis age was 65 years old (range 57-70 years). This age is lower than the average age of the patients with brain metastasis reported by previous studies.(https://moffitt.org/cancers/brain-metastases/treatment/chemotherapy/).

Anonymous Patient Answer

Is radiosurgery safe for people?

If GKS is used in selected cases, radiosurgery is a safe modality in the treatment of metastatic brain tumors. However such treatments can cause side effects, therefore it is important to assess the patients before considering such interventions.

Anonymous Patient Answer

How serious can tumors metastatic to brain be?

There can be neurological symptoms resulting from the tumor metastatic to brain. The most common symptoms are headache, sleep disturbances, dizziness, difficulty with balance, confusion, and changes in visual field. Patients must be monitored for cancer metastasis including MRI of brain, imaging, or surgical removal as needed. When cancer metastatic to brain progresses to disseminated tumors, patients will need chemotherapy and radiotherapy. Radiation therapy is an important tool to treat brain metastasis. When cancer metastatic to brain is uncontrolled by radiotherapy, surgery is the best way to treat. Surgery is effective, but is not a cure.

Anonymous Patient Answer
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