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Lower Radiotherapy Dose for Brain Tumors

Phase 2

Recruiting

Led By Mohamed Abdelbaki, MD

Research Sponsored by Children's Oncology Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients ≤ 16 years of age

Patients must be newly-diagnosed primary localized germinoma of the suprasellar and/or pineal region by pathology and/or serum and/or CSF hCGbeta 5-50 mIU/mL AND institutional normal AFP (or ≤ 10 ng/mL if no institutional normal exists), including tumors with contiguous ventricular or unifocal parenchymal extension. No histologic confirmation required

Must not have

Patients with any of the following malignant pathological elements are not eligible:

Patients with only mature teratoma upon tumor sampling at diagnosis and negative tumor markers are not eligible

Timeline

Screening 3 weeks

Treatment Varies

Follow Up evaluated at 2- and 3-years post-radiation initiation

Awards & highlights

No Placebo-Only Group

Summary

"This trial is testing if giving lower doses of radiation therapy after chemotherapy can effectively treat CNS germinomas in children. The chemotherapy drugs being used are carboplatin and etoposide, which work

Who is the study for?

This trial is for children and young adults aged 3 to less than 30 with CNS germinoma, a type of brain tumor. It includes those newly diagnosed, with certain levels of specific markers in their blood or CSF, and can have tumors in various brain regions or with spread within the central nervous system. Participants need confirmed diagnoses via imaging or pathology and must be able to perform daily activities.

What is being tested?

The study tests if lower doses of radiotherapy after chemotherapy (using Carboplatin and Etoposide) are effective for treating CNS germinomas in children. The goal is to see if this approach reduces long-term side effects while still eliminating cancer cells. Techniques include advanced radiation therapy methods alongside surgery, MRI monitoring, lumbar puncture, biospecimen collection, and questionnaires.

What are the potential side effects?

Potential side effects may include reactions from chemotherapy drugs like nausea, hair loss, fatigue; risks associated with radiation such as skin irritation; complications from surgical procedures; discomfort from lumbar punctures; and possible anxiety related to questionnaire administration.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself but may not be able to do active work.

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I have a new diagnosis of a specific brain tumor with certain test results.

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I am between 3 and 29 years old.

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My brain-related side effects are mild.

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I am HIV positive, on treatment, and my viral load is undetectable.

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My tests show specific hCGbeta and AFP levels, and I have a confirmed diagnosis of germinoma.

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I had a spine MRI with contrast when I was diagnosed.

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I have had a brain MRI with and without contrast before joining the trial.

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My white blood cell count is high enough for treatment.

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My cancer has spread to my brain, ventricles, or spine.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer does not have specific malignant features listed as exclusion criteria.

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My cancer is not just a mature teratoma with negative tumor markers.

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I have only had surgery or corticosteroids for my germinoma, no other treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ evaluated at 2- and 3-years post-radiation initiation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~evaluated at 2- and 3-years post-radiation initiation

This trial's timeline: 3 weeks for screening, Varies for treatment, and evaluated at 2- and 3-years post-radiation initiation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Event-free survival (EFS) (Stratum I)

Secondary study objectives

EFS (Stratum II)

EFS (Stratum III)

Marker tumor response rate

+4 more

Other study objectives

EFS (Stratum IV and Stratum V)

EFS (Stratum VI and Stratum VII)

Health-reported quality of life

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

7Treatment groups

Experimental Treatment

Group I: Stratum VII (carboplatin, etoposide, 3D-CRT, IMRT)Experimental Treatment8 Interventions

Patients receive carboplatin IV over 15-60 minutes on day 1 and etoposide IV over 90-120 minutes on days 1-3 of each cycle. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients with basal ganglia and thalamic germinoma with normalization of markers who fail to achieve CR who do not undergo second-look surgery undergo 3DRT or IMRT QD 5 days a week for 24 days. Patients undergo MRI and optional blood and tissue sample collection throughout the study. Patients may undergo LP for CSF sample collection during screening and follow up.

Group II: Stratum VI (carboplatin, etoposide, 3D-CRT, IMRT, surgery)Experimental Treatment9 Interventions

Patients receive carboplatin IV over 15-60 minutes on day 1 and etoposide IV over 90-120 minutes on days 1-3 of each cycle. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients with basal ganglia and thalamic germinoma achieving CR undergo 3DRT or IMRT QD 5 days a week for 20 days. Patients with basal ganglia and thalamic germinoma and normalization of markers who fail to achieve CR may undergo second-look surgery. Patients found to have mature teratoma or non-viable tumor undergo 3DRT or IMRT QD 5 days a week for 20 days. Patients undergo MRI and optional blood and tissue sample collection throughout the study. Patients may undergo LP for CSF sample collection during screening and follow up.

Group III: Stratum V (carboplatin, etoposide, 3D-CRT, IMRT)Experimental Treatment8 Interventions

Patients receive carboplatin IV over 15-60 minutes on day 1 and etoposide IV over 90-120 minutes on days 1-3 of each cycle. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients with metastatic germinoma with normalization of markers who fail to achieve CR who do not undergo second-look surgery undergo 3DRT or IMRT QD 5 days a week for 24 days. Patients undergo MRI and optional blood and tissue sample collection throughout the study. Patients may undergo LP for CSF sample collection during screening and follow up.

Group IV: Stratum IV (carboplatin, etoposide, 3D-CRT, IMRT, surgery)Experimental Treatment9 Interventions

Patients receive carboplatin IV over 15-60 minutes on day 1 and etoposide IV over 90-120 minutes on days 1-3 of each cycle. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients with metastatic germinoma achieving CR undergo 3DRT or IMRT QD 5 days a week for 20 days. Patients with metastatic germinoma and normalization of markers who fail to achieve CR may undergo second-look surgery. Patients found to have mature teratoma or non-viable tumor undergo 3DRT or IMRT QD 5 days a week for 20 days. Patients undergo MRI and optional blood and tissue sample collection throughout the study. Patients may undergo LP for CSF sample collection during screening and follow up.

Group V: Stratum III (carboplatin, etoposide, 3D-CRT, IMRT)Experimental Treatment8 Interventions

Patients receive carboplatin IV over 15-60 minutes on day 1 and etoposide IV over 90-120 minutes on days 1-3 of each cycle. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients with localized germinoma with normalization of markers who fail to achieve CR or PR who do not undergo second-look surgery undergo 3DRT or IMRT QD 5 days a week for 24 days. Patients undergo MRI and optional blood and tissue sample collection throughout the study. Patients may undergo LP for CSF sample collection during screening and follow up.

Group VI: Stratum II (carboplatin, etoposide, 3D-CRT, IMRT)Experimental Treatment8 Interventions

Patients receive carboplatin IV over 15-60 minutes on day 1 and etoposide IV over 90-120 minutes on days 1-3 of each cycle. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients with localized germinoma achieving PR with normalization of markers who do not undergo second-look surgery undergo 3DRT or IMRT QD 5 days a week for 20 days. Patients undergo MRI and optional blood and tissue sample collection throughout the study. Patients may undergo LP for CSF sample collection during screening and follow up.

Group VII: Stratum I (carboplatin, etoposide, 3D-CRT, IMRT, surgery)Experimental Treatment9 Interventions

See Detailed Description.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carboplatin

2014

Completed Phase 3

~6120

Etoposide

2010