CLINICAL TRIAL

Irradiation for Ependymoma

1 Prior Treatment
Metastatic
Recurrent
Waitlist Available · < 65 · All Sexes · Memphis, TN

This study is evaluating whether surgery and re-irradiation will help treat ependymoma that has come back after initial treatment.

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About the trial for Ependymoma

Treatment Groups

This trial involves 4 different treatments. Irradiation is the primary treatment being studied. Participants will be divided into 4 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Experimental Group 1
^1^1C-methionine
DRUG
+
Photon therapy
DEVICE
+
Proton therapy
DEVICE
+
^1^8F-Fluorodeoxyglucose
DRUG
+
Irradiation
RADIATION
+
Surgery
PROCEDURE
Experimental Group 2
^1^1C-methionine
DRUG
+
Photon therapy
DEVICE
+
Proton therapy
DEVICE
+
^1^8F-Fluorodeoxyglucose
DRUG
+
Irradiation
RADIATION
+
Surgery
PROCEDURE
Experimental Group 3
^1^1C-methionine
DRUG
+
Photon therapy
DEVICE
+
Proton therapy
DEVICE
+
^1^8F-Fluorodeoxyglucose
DRUG
+
Irradiation
RADIATION
+
Surgery
PROCEDURE
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About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Proton therapy
2011
N/A
~30
Irradiation
2015
N/A
~490
Surgery
1999
Completed Phase 3
~2060

Eligibility

This trial is for patients born any sex aged 65 and younger. You must have received 1 prior treatment for Ependymoma. 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:
Patients with a good performance status (ECOG score of 3 or less) and who do not require mechanical ventilation are good candidates for clinical trials. show original
More than 9 months elapsed between the start of radiation therapy and the patient's enrollment in the study. show original
A tumor developed in the brain after radiation therapy was given to a previous tumor. show original
Patients aged 1-21 years at the time of enrollment
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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: Baseline, and at 12, 24 and 36 month
Screening: ~3 weeks
Treatment: Varies
Reporting: Baseline, and at 12, 24 and 36 month
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Baseline, and at 12, 24 and 36 month.
View detailed reporting requirements
Trial Expert
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- 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 Irradiation will improve 2 primary outcomes, 24 secondary outcomes, and 7 other outcomes in patients with Ependymoma. Measurement will happen over the course of Baseline.

Avidity of ependymoma to 18F-fluorodeoxyglucose and 11C-methionine PET prior to radiation therapy
BASELINE
Baseline is the last FDG-PET and MET-PET prior to initiation of radiation therapy.
BASELINE
Genetic variations in germline
BASELINE
Evaluate will be of genetic variations in germline associated with treatment response and side effects. P-values will be reported. Baseline is defined as day 1 of radiation therapy.
BASELINE
Mean change in overall coordination
FINE MOTOR COORDINATION (FINGER AND HAND COORDINATION).
Baseline is defined as day 1 of radiation therapy. Overall coordination measured by brief ataxia rating scale (five-item questionnaire). The outcome is a total scale range from 0 to 22.
FINE MOTOR COORDINATION (FINGER AND HAND COORDINATION).
3-year progression-free survival rate
2 YEARS FOLLOW-UP AFTER INITIATION OF RADIATION THERAPY FOR THE LAST PATIENT ENROLLED
2 YEARS FOLLOW-UP AFTER INITIATION OF RADIATION THERAPY FOR THE LAST PATIENT ENROLLED
3-year overall survival rate
2 YEARS FOLLOW-UP AFTER INITIATION OF RADIATION THERAPY FOR THE LAST PATIENT ENROLLED
2 YEARS FOLLOW-UP AFTER INITIATION OF RADIATION THERAPY FOR THE LAST PATIENT ENROLLED
Longitudinal change in gray and white matter tissues
BASELINE TO RECOVERY OF GRAY AND WHITE MATTER TRACT INJURY, UP TO A MAXIMUM OF 5 YEARS
This outcome will be evaluated by neuroimaging. Baseline is defined as day 1 of radiation therapy.
BASELINE TO RECOVERY OF GRAY AND WHITE MATTER TRACT INJURY, UP TO A MAXIMUM OF 5 YEARS
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Patient Q & A Section

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

Can ependymoma be cured?

There is no evidence that ependymoma can be cured, nor can it be completely cured. The potential for cure remains high despite a large number of patients treated with RT, albeit many of whom are undertreated.

Anonymous Patient Answer

What is ependymoma?

Ependymoma is a rare type of brain tumor that typically forms in young children, affects the spinal cord and is characterized by blood vessels and glial cells. It is a benign but potentially disabling disease that may also cause death by brain obstruction. The diagnosis often requires a multimodial approach.

Anonymous Patient Answer

What are the signs of ependymoma?

Signs of ependymoma in children include unexplained headache, abdominal pain or constipation. In adults, they can include neck pain, vomiting or urinary retention.\n\nOn examination, signs of ependymoma may include palpable cerebellar or spinal masses and ipsilateral pleural effusions.\n\nThe differential diagnosis for spinal mass and/or pleural effusion include lymphomas, carcinomatosis, metastatic disease or metastatic tumors from another primary tumor.\n\nThe treatment for ependymoma depends upon where the ependymoma may be located within the central nervous system (CNS).

Anonymous Patient Answer

What causes ependymoma?

Although we hypothesize a potential role of oncogenic genetic events such as mutations in RAS or EGFR, we found no evidence of mutations in the genes or genes involved in mitogen-activated protein kinase or the proto-oncogene pathways in ependymomas. Therefore, the possibility of genetic alterations in ependymomas is still questioned.

Anonymous Patient Answer

What are common treatments for ependymoma?

Almost one-half of ependymomas were surgically and/or radiologically eradicated by surgery alone or in conjunction with radiotherapy. Of the 22 % who were not completely eradicated, about 90 % underwent radiotherapy. The remainder received postoperative radiotherapy combined with chemotherapy or radiation. In general, patients whose disease was well localized could be treated using surgery alone with an excellent prognosis. However, these results are difficult to interpret because there is no evidence-based standard therapy. In addition to surgical removal and high-dose radiation therapy, we believe multimodal therapies containing chemotherapy should be encouraged in patients with well-differentiated and low-grade ependymomas with a single nonenhancing tumor.

Anonymous Patient Answer

How many people get ependymoma a year in the United States?

In the U.S. population, the age-standardized incidence per 10,000 of ependymoma is 2.2 in males and 1.9 in females, and the age-standardized mortality rate is 0.6 per 10,000 of population. The incidence rate increased between 1997 and 2005. The age-standardized incidence rate has remained stable since 1996, and the age-standardized mortality rate was decreased from 1996 to 2005. These national trends suggest a decrease in ependymoma incidence from the early 1990s to 2005 but no decline in mortality.

Anonymous Patient Answer

Is irradiation typically used in combination with any other treatments?

More than 70% of patients with newly treated primary PNETs experienced disease progression. Although radiation therapy is important in controlling disease, its efficacy appears to be limited. At present, new therapeutic approaches are required that maximize disease control while limiting treatment-associated toxicity.

Anonymous Patient Answer

Does irradiation improve quality of life for those with ependymoma?

Irradiation resulted in a significant, but small, improvement in one domain of quality of life. In the larger group of patients with ependymoma, the greatest change was in the general physical fitness. In a recent study, findings highlight a need for larger studies to assess the impact of irradiation on quality of life.

Anonymous Patient Answer

How does irradiation work?

This analysis suggests that ionizing radiation does not appear to confer any additional benefit for patients with a first complete remission of GBM versus those treated with surgery.

Anonymous Patient Answer

Does ependymoma run in families?

Most families with a diagnosis of cED have one or more members with multiple cED cases. However, there is an absence of familial cases among the sporadic cED population, supporting genetic and epigenetic models for the disease.

Anonymous Patient Answer

Have there been any new discoveries for treating ependymoma?

ependymoma is best managed by multidisciplinary treatment with surgery, chemotherapy, and radiotherapy. It can also be targeted by gene therapy, chemotherapy, or other novel treatments. Unfortunately, clinical trials for these treatments do not have any standards.

Anonymous Patient Answer

Has irradiation proven to be more effective than a placebo?

The present study suggests that a total dose of 70 Gy is more effective in the treatment of brainstem-ependymal tumors than a dosage of 30 Gy or a placebo, at least when treated early after diagnosis.

Anonymous Patient Answer
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