Surgery + Re-Irradiation for Recurrent Ependymoma

Not currently recruiting at 1 trial location
Age: < 65
Sex: Any
Trial Phase: Phase 2
Sponsor: St. Jude Children's Research Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if surgery combined with a second round of radiation (re-irradiation) can effectively treat ependymoma, a brain tumor that has returned after initial treatment. Researchers are assessing the effectiveness of this approach and potential side effects. They will analyze tumor and blood samples to understand the tumor's response to treatment and use advanced imaging techniques to predict treatment outcomes. Individuals whose brain tumor has recurred after radiation and who have not undergone whole-brain radiation may be suitable candidates for this trial. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that surgery and additional radiation can effectively treat recurrent ependymoma, a type of brain tumor. Studies have found that patients often live longer, especially when surgeons completely remove the tumor, a procedure known as gross total resection (GTR).

These treatments are generally safe and well-tolerated. One study found that patients with recurring ependymoma managed the treatments well and maintained good control over the tumor in the treated area. However, there remains a risk of the cancer spreading to other parts of the body.

While these treatments appear promising, it is important to note that the trial is in Phase 2. Researchers are still evaluating the safety and effectiveness of the treatments. Participants should be aware that higher doses of radiation are being used, which might cause more side effects. Discussing potential risks and benefits with a healthcare provider before joining a trial is always advisable.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for recurrent ependymoma because they combine surgery with advanced re-irradiation techniques like photon and proton therapy. Unlike traditional treatments that might focus solely on either surgery or radiation, this approach uses both to target tumor cells more effectively. Additionally, the use of imaging agents like ^18F-fluorodeoxyglucose and ^11C-methionine helps visualize the tumor better, potentially leading to more precise treatment. This dual strategy aims to improve outcomes in cases of local or metastatic recurrence, offering hope for those with this challenging condition.

What evidence suggests that surgery and re-irradiation could be effective for recurrent ependymoma?

Research has shown that combining surgery with a second round of radiation therapy can help treat recurrent ependymoma. In this trial, participants will be assigned to different treatment arms based on their pattern of disease failure. Some will receive surgery and craniospinal irradiation, while others will receive surgery and a second course of focal irradiation. Studies have found that this approach can help patients live longer without the cancer worsening and can also increase overall survival rates. Specifically, one retrospective study found that a second round of targeted radiation given in small doses was effective when ependymoma returned, with fewer instances of the cancer spreading. These findings suggest that using both surgery and re-irradiation could be a promising option for those facing recurrent ependymoma.12367

Who Is on the Research Team?

TE

Thomas Merchant

Principal Investigator

St. Jude Children's Research Hospital

Are You a Good Fit for This Trial?

This trial is for individuals aged 1-21 with recurrent ependymoma, a type of brain tumor, after initial radiation treatment. They must be at least 9 months post-initial therapy and able to perform daily activities without mechanical ventilation. Pregnant women, patients who had prior full-spine irradiation or are under 3 years old with metastatic ependymoma cannot participate.

Inclusion Criteria

My brain tumor has grown despite previous radiation treatment.
It has been over 9 months since my first radiation treatment.
I can care for myself and do not need a machine to help me breathe.
See 1 more

Exclusion Criteria

I am under 3 years old with a type of cancer called metastatic ependymoma.
Pregnant women are excluded from enrollment on this study because radiation therapy is an agent with the potential for teratogenic or abortifacient effects
I have had radiation therapy to my brain and spine.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo surgery as part of the treatment for recurrent ependymoma

1 week

Radiation Therapy

Participants receive fractionated re-irradiation therapy, with evaluations done weekly

7 weeks
Weekly visits during therapy

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years
Every 4 months for 3 years, then every 6 months for 2 years

What Are the Treatments Tested in This Trial?

Interventions

  • Irradiation
  • Surgery
Trial Overview The study tests if surgery combined with higher-than-usual doses of re-irradiation can treat recurring ependymoma. It includes analyzing tumor tissue and blood samples, using MRI and PET scans to monitor the tumor's response to treatments over a period of up to five years.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Group I: Stratum 4: Local FailureExperimental Treatment6 Interventions
Group II: Stratum 3: Local and Metastatic FailureExperimental Treatment6 Interventions
Group III: Stratum 2: Metastatic FailureExperimental Treatment6 Interventions
Group IV: Stratum 1: Local FailureExperimental Treatment6 Interventions

Irradiation is already approved in European Union, United States, China for the following indications:

🇪🇺
Approved in European Union as Radiation therapy for:
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Approved in United States as Radiotherapy for:
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Approved in China as Irradiation treatment for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

St. Jude Children's Research Hospital

Lead Sponsor

Trials
451
Recruited
5,326,000+

Published Research Related to This Trial

Complete surgical resection of ependymomas significantly improves patient survival, making it crucial to evaluate the extent of disease through cerebrospinal fluid cytology and MRI before deciding on treatment.
For patients with residual disease who cannot undergo further surgery, limited-field radiotherapy is typically used, but the effectiveness of craniospinal irradiation remains debated due to the tendency for local recurrences.
Ependymomas.Chowdhary, S., Green, MR., Chamberlain, M.[2022]
Radiotherapy (RT) for spinal ependymoma, particularly in patients with adverse features like incomplete resection or disseminated disease, resulted in a 5-year overall survival rate of 83.7% and a progression-free survival rate of 70.8% based on a study of 25 patients.
Patients with grade I ependymoma had significantly better survival outcomes compared to those with grade II/III, indicating that tumor grade is an important factor in predicting the effectiveness of RT, while the treatment was generally safe with minimal late toxicities observed.
Clinical outcomes of radiotherapy for spinal cord ependymoma with adverse prognostic features: a single-center study.Byun, HK., Yi, S., Yoon, HI., et al.[2019]

Citations

Reevaluating surgery and re-irradiation for locally recurrent ...This study describes significantly improved outcomes in progression-free survival (PFS) and overall survival (OS) when patients with locally recurrent ...
A Retrospective Study of Surgery and Reirradiation for ...The outcome of recurrent ependymoma in children is dismal. Reirradiation has been proposed as an effective modality for ependymoma at relapse. However, the ...
A Retrospective Study of Surgery and Reirradiation for ...Three of 13 patients treated using focal fractionated reirradiation (median combined dose, 111.6 Gy) experienced metastasis. The CSI was administered to 12 ...
A Phase II Trial of Surgery and Fractionated Re-Irradiation ...Surgery is an important part of this study and will be used to document recurrent ependymoma and reduce the tumor burden when feasible. Patients ...
Treatment Outcomes of Patients with Ependymoma ...Introduction: This study explored the failure pattern and clinical outcomes in patients with ependymoma undergoing radiotherapy.
Surgery + Re-Irradiation for Recurrent EpendymomaPatients with grade I ependymoma had significantly better survival outcomes compared to those with grade II/III, indicating that tumor grade is an important ...
The role of surgery in recurrent ependymomas inGTR of local recurrent ependymomas can result in long-term survival in first and second recurrences.
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