CLINICAL TRIAL

whole brain radiation therapy for Neoplasm Metastasis

Metastatic
Recruiting · 18+ · All Sexes · Baltimore, MD

This study is evaluating whether a type of radiation therapy may help preserve cognition and neuropsychiatric function following radiation therapy for brain metastases.

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About the trial for Neoplasm Metastasis

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

Treatment Groups

This trial involves 2 different treatments. Whole Brain Radiation Therapy 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.
whole brain radiation therapy
RADIATION
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
whole brain radiation therapy
2016
Completed Phase 1
~20

Eligibility

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.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Mini Mental State Examination (MMSE) ≥24
Age≥ 18 years
Karnofsky Performance Status (KPS) ≥70
Patient does not have metastases to the genu
Patient must be scheduled to undergo treatment with whole brain radiation therapy (WBRT) to manage the brain metastases
Patients of childbearing potential (male or female) must practice adequate contraception due to possible harmful effects of radiation therapy on an unborn child
Patient must have the ability to understand and the willingness to sign a written informed consent document
All patients must be informed of the investigational nature of this study and must be given written informed consent in accordance with institutional and federal guidelines
Patient must have a minimal life expectancy of at least 6 months
Histologic proof or unequivocal cytologic proof solid tumor malignancy. This may be obtained from either the primary or any metastatic site
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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: 4, 6 and 12 months
Screening: ~3 weeks
Treatment: Varies
Reporting: 4, 6 and 12 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 4, 6 and 12 months.
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 whole brain radiation therapy will improve 1 primary outcome and 5 secondary outcomes in patients with Neoplasm Metastasis. Measurement will happen over the course of 4 months.

Rate of change of cognitive function
4 MONTHS
Evaluate changes in cognition from baseline to 4 months following genu-sparing whole brain radiation therapy (GS-WBRT)
4 MONTHS
Rate of change of cognition
4, 6 AND 12 MONTHS
Evaluate changes in cognition from baseline to 4, 6 and 12 months following GS-WBRT
4, 6 AND 12 MONTHS
Rate of change in other frontally-mediated functions
4, 6 AND 12 MONTHS
Document the stability of other frontally-mediated cognitive functions in those receiving GS-WBRT from pre-treatment to 4, 6 and 12 months following GS-WBRT.
4, 6 AND 12 MONTHS
Rate of change in QoL
4, 6 AND 12 MONTHS
Document changes in QOL, neuropsychiatric symptoms, and functioning in patients receiving GS-WBRT from pre-treatment to 4, 6 and 12 months following GS-WBRT
4, 6 AND 12 MONTHS
Time to brain metastasis
4, 6 AND 12 MONTHS
Document development of brain metastases in the spared genu of the corpus callosum
4, 6 AND 12 MONTHS
Rate of change of white matter microstructure
4, 6 AND 12 MONTHS
Evaluate change in white matter microstructure following GS-WBRT utilizing diffusion tensor imaging
4, 6 AND 12 MONTHS

Patient Q & A Section

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

What is neoplasm metastasis?

Neoplasm metastasis is the process of tumors cells from primary tumors colonizing distant sites. This process includes dissemination of metastatic dissemination, implantation and formation of a metastatic mass. It is typically caused by the dissemination of tumor cells in the tissues or lymphatic system. In neoplasm metastasis a neoplasm invades non-neoplasm tissues, but then breaks the tissue architecture. Neoplasm dissemination of metastatic dissemination is related with the characteristic of invasive growth, and its growth is also closely related to the characteristic of metastatic dissemination.

Anonymous Patient Answer

How many people get neoplasm metastasis a year in the United States?

Approximately 3% of all malignancies are metastatic. The mortality for [metastatic breast cancer](https://www.withpower.com/clinical-trials/metastatic-breast-cancer) is approximately 80%, while there are still a lot of research about other cancers, its exact incidence, and specific mortality are still unknown.

Anonymous Patient Answer

Can neoplasm metastasis be cured?

The best chances are in cancer with limited stage and low grade. Survival rates may be improved with local treatments, radiation, chemotherapy, and/or surgery. Radiation therapy often cures metastatic disease in the lung, prostate, and brain. Chemotherapy may be successful in the treatment of prostate cancer. Surgery may be beneficial in localised disease or where there is no alternative treatment (palliative).

Anonymous Patient Answer

What are the signs of neoplasm metastasis?

Signs and symptoms of neoplasm metastasis include: (i) bone pain; (ii) local swelling of axilla or leg and (iii) enlargement of axillary lymph nodes. Some neoplasm metastasis has no sign at all.

Anonymous Patient Answer

What are common treatments for neoplasm metastasis?

The treatment for metastasis of human neoplasm should be performed after a definite diagnosis. Local treatment includes radiotherapy, surgery, radiation therapy, chemotherapy, targeted therapy, hormonal therapy, immunotherapy, or combined therapy.

Anonymous Patient Answer

What causes neoplasm metastasis?

Metastasis is caused by a disruption of the normal balance of growth and death dynamics of malignant neoplasm cells. A number of factors influence metastasis in neoplasm, including the primary cancer site, anatomic location, and histologic type, and the presence of metastases can be divided into "local neoplasm metastasis" and "systemic neoplasm metastasis" depending on the mode of spread to or from the primary site.

Anonymous Patient Answer

What is the survival rate for neoplasm metastasis?

[There are many treatments to cure cancer metastasis, such as chemotherapy, surgery, and radiation therapy. However, a cure for metastatic cancer is still elusive. A report showed thatmore than 10% of the patients who had liver metastasis of colorectal cancer will have a prolonged survival time. Although a cure for cancer will emerge in the near future, it will not be overnight. To get the latest information and treatment for metastatic cancers, you can use [withpower] to search.

Anonymous Patient Answer

Is whole brain radiation therapy typically used in combination with any other treatments?

In this retrospective analysis, BCT was associated with improved OS and CSS relative to NBM and CMT and was associated with improved PFS relative to CMT and NBM. Findings from a recent study support the inclusion of BCT in the treatment of NBM in select patients.

Anonymous Patient Answer

Does neoplasm metastasis run in families?

Results from a recent paper demonstrated that family history, familial location, and the type of tumor did not contribute to more than 20% of metastatic neoplasm cases. The incidence of metastasis as well as the mortality rate in family history nonfamilial cases, was not significant. The probability of metastasis in family history cases, however higher than nonfamilial family cases.

Anonymous Patient Answer

Is whole brain radiation therapy safe for people?

WBRT does not appear to be less safe than the general medical treatment in most circumstances described. WBRT is effective, but is not a panacea in any single patient. The risks and benefits of WBRT should be carefully weighed against the risks of general medical therapy on patients with symptomatic or newly diagnosed malignancies of low-grade at high risk for recurrent malignancy.

Anonymous Patient Answer

How quickly does neoplasm metastasis spread?

The probability of metastasis in breast cancer increases in the order of steps from primary tumor stage to local lymph node involvement to regional and then distant metastasis. The metastatic spread rate increases in the same order but more quickly for patients with stage IVB disease (99.9 ± 0.0% 5 months) compared with patients with only local metastatic spread (92.2 ± 0.9%. p<0.05, two-sample z-test).

Anonymous Patient Answer

Have there been other clinical trials involving whole brain radiation therapy?

There have been many small, uncontrolled studies that have tried to verify the effect that WBRT had on other neurological symptoms in patients with newly diagnosed or progressive cancer. However, there has never been enough evidence to support using WBRT alone in the management of patients with newly diagnosed cancers in that it could cause severe and fatal side effects. Patients with progressive cancer who received WBRT for their primary disease received no further benefit and, in our opinion, had an increased risk for fatal side effects. More research in clinical trials with large numbers of patients should be conducted before clinicians recommend WBRT for patients with newly diagnosed cancers.

Anonymous Patient Answer
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