Lower dose radiotherapy for treating children with CNS germinoma
Official title: A Phase II Trial Evaluating Chemotherapy Followed by Response-Based Reduced Radiation Therapy for Patients With Central Nervous System Germinomas
Run by Children's Oncology Group · NCT06368817 · Data updated 2026-11-12
This study is testing if giving a lower dose of radiotherapy after chemotherapy can effectively treat children with CNS germinomas while reducing side effects.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 3 Years to 29 Years |
| Sex | All |
| Enrollment | 240 (estimated) |
| Sponsor | Children's Oncology Group Research network |
| Drugs / interventions | chemotherapy, Radiation |
| Locations | 115 sites (Mobile, Alabama and 114 other locations) |
| Status | Recruiting |
| Started | October 22, 2024 |
| Main results expected | November 4, 2033 |
| Study ends | November 4, 2033 |
| Registry record updated | August 25, 2026 |
| Trial ID | NCT06368817 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 3 to 30 years with newly diagnosed localized CNS germinoma and specific tumor characteristics.
✕Probably not a fit
Patients with advanced or non-localized germinoma or those outside the specified age range may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase II trial investigates the effectiveness of a reduced dose of radiotherapy following chemotherapy with Carboplatin and Etoposide in children diagnosed with central nervous system (CNS) germinomas. The study aims to determine if administering 12 Gy whole ventricular irradiation and a tumor boost can maintain similar efficacy compared to standard treatments while potentially reducing long-term side effects. Researchers will evaluate event-free survival and overall survival rates, as well as the impact on neuroendocrine function and cognitive processing speed in participants. The trial includes various cohorts based on tumor response to prior treatments.
Why it matters
Potential benefit: If successful, this approach could lead to effective treatment of CNS germinomas with fewer long-term side effects for pediatric patients.
How similar studies have gone: Other studies have shown promise in reducing radiation doses for similar conditions, suggesting this approach may be beneficial.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Patients must be ≥ 3 years and \< 30 years at the time of study enrollment
* 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
* Patients with EITHER (A) bifocal (pineal + suprasellar) involvement OR (B) pineal lesion with diabetes insipidus (DI) AND hCGbeta ≤ 100 mIU/mL in serum and/or CSF AND institutional normal AFP (or ≤ 10 ng/mL if no institutional normal exists) in both serum and CSF. No histologic confirmation required
* Patients with hCGbeta 51-100 mIU/mL in serum and/or CSF and institutional normal AFP (or ≤ 10 ng/mL if no institutional normal exists) in both serum and CSF. Histologic confirmation of germinoma IS required
* Patients with germinoma of the basal ganglia and or/thalamic primary sites are eligible
* Patients with metastatic germinoma including non-contiguous disease or distant disease in the brain, ventricles, or spine are eligible
* Patients with germinoma admixed with mature teratoma are eligible
* 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 have eligibility confirmed by Rapid Central Imaging Review performed on APEC14B1-CNS
* Imaging studies must be obtained within 31 days prior to study enrollment and start of protocol therapy. (Note: for patients that have had surgery and post-operative imaging performed, it is the post-operative MRI that must be obtained within 31 days prior to enrollment.)
* Patients must have a cranial magnetic resonance imaging (MRI) with and without gadolinium at diagnosis/prior to enrollment. If surgical resection is performed, patients must have pre-operative and post-operative brain MRI with and without gadolinium. The post-operative brain MRI should be obtained within 72 hours of surgery. If patient has a biopsy only, post-operative brain MRI is recommended but not required
* Patients must have a spine MRI with gadolinium obtained at diagnosis/prior to enrollment
* Patients must be enrolled, and protocol therapy must begin, no later than 31 days after definitive surgery or clinical diagnosis, whichever is later
* Patients must have eligibility confirmed by Rapid Central Tumor Marker Review performed on APEC14B1-CNS
* Lumbar CSF must be obtained prior to study enrollment unless medically contraindicated. If a patient undergoes surgery and lumbar CSF cytology cannot be obtained at the time of surgery, then it should be performed at least 10 days following surgery and prior to study enrollment. False positive cytology can occur within 10 days of surgery. Of note, lumbar CSF should not be performed prior to obtaining spine MRI, as this can make interpretation of the spine MRI less clear
* Patients must have CSF tumor markers obtained prior to study enrollment unless medically contraindicated. Ventricular CSF obtained at the time of CSF diversion procedure (if performed) is acceptable for tumor markers but lumbar CSF is preferred. In case CSF diversion and biopsy/surgery are combined, CSF tumor markers should be collected first. Ideally serum and CSF tumor markers should be collected at the same time and processed without delay
* For patients with solid tumors: Peripheral absolute neutrophil count (ANC) \>= 1000/uL (Must be performed within 7 days prior to enrollment unless otherwise indicated)
* For patients with solid tumors: Platelet count \>= 100,000/uL (transfusion independent) (Must be performed within 7 days prior to enrollment unless otherwise indicated)
* For patients with solid tumors: Hemoglobin \>= 8.0 g/dL (may receive red blood cell \[RBC\] transfusions) (Must be performed within 7 days prior to enrollment unless otherwise indicated)
* For pediatric patients (age 3-17 years): A serum creatinine based on age/sex as follows (Must be performed within 7 days prior to enrollment unless otherwise indicated):
* Age: 3 to \< 6 years; maximum serum creatinine (mg/dL): 0.8 (male); 0.8 (female)
* Age: 6 to \< 10 years; maximum serum creatinine (mg/dL): 1 (male); 1 (female)
* Age: 10 to \< 13 years; maximum serum creatinine (mg/dL): 1.2 (male); 1.2 (female)
* Age: 13 to \< 16 years; maximum serum creatinine (mg/dL): 1.5 (male); 1.4 (female)
* Age: ≥ 17 years; maximum serum creatinine (mg/dL): 1.7 (male); 1.4 (female) OR a 24-hour urine creatinine clearance ≥ 70 mL/min/1.73 m\^2 OR a glomerular filtration rate (GFR) ≥ 50 mL/min/1.73 m\^2. GFR must be performed using direct measurement with a nuclear blood sampling method OR direct small molecule clearance method (iothalamate or other molecule per institutional standard).
* Note: Estimated GFR (eGFR) from serum or plasma creatinine, cystatin C or other estimates are not acceptable for determining eligibility.
* For adult patients (age 18 years or older) (Must be performed within 7 days prior to enrollment unless otherwise indicated):
* Creatinine clearance ≥ 70 mL/min, as estimated by the Cockcroft and Gault formula or a 24-hour urine collection. The creatinine value used in the calculation must have been obtained within 28 days prior to registration. Estimated creatinine clearance is based on actual body weight
* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age (Must be performed within 7 days prior to enrollment unless otherwise indicated)
* Serum glutamic-pyruvic transaminase (SGPT) (alanine transaminase \[ALT\]) ≤ 135 U/L (Must be performed within 7 days prior to enrollment unless otherwise indicated)
* Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L
* No evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry \> 94% if there is clinical indication for determination
* Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled
* CNS toxicity =\< grade 2
* Patients must not be in status epilepticus, coma or assisted ventilation prior to study enrollment
* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load are eligible for this study
Exclusion Criteria:
* Patients with any of the following malignant pathological elements are not eligible:
* Endodermal sinus (yolk sac)
* Embryonal carcinoma, choriocarcinoma
* Malignant/immature teratoma and mixed germ cell tumor (GCT) (i.e., may include some germinoma)
* Patients with only mature teratoma upon tumor sampling at diagnosis and negative tumor markers are not eligible
* Patients who have received any prior tumor-directed therapy for their diagnosis of germinoma other than surgical intervention and corticosteroids are not eligible
* Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential.
* Note: Serum and urine pregnancy tests may be falsely positive due to HCGbeta-secreting germ cell tumors. Ensure the patient is not pregnant by institutional standards
* Lactating females who plan to breastfeed their infants
* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation
* All patients and/or their parents or legal guardians must sign a written informed consent
* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Where it's running
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USA Health Strada Patient Care Center
Mobile, Alabama, United States Recruiting -
Phoenix Childrens Hospital
Phoenix, Arizona, United States Recruiting -
Arkansas Children's Hospital
Little Rock, Arkansas, United States Recruiting -
Loma Linda University Medical Center
Loma Linda, California, United States Recruiting -
Children's Hospital Los Angeles
Los Angeles, California, United States Recruiting -
UCSF Benioff Children's Hospital Oakland
Oakland, California, United States Recruiting
Show 44 more locations
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Children's Hospital of Orange County
Orange, California, United States Recruiting -
Lucile Packard Children's Hospital Stanford University
Palo Alto, California, United States Recruiting -
Rady Children's Hospital - San Diego
San Diego, California, United States Recruiting -
UCSF Medical Center-Mission Bay
San Francisco, California, United States Recruiting -
Children's Hospital Colorado
Aurora, Colorado, United States Recruiting -
Connecticut Children's Medical Center
Hartford, Connecticut, United States Recruiting -
Yale University
New Haven, Connecticut, United States Recruiting -
Alfred I duPont Hospital for Children
Wilmington, Delaware, United States Recruiting -
Children's National Medical Center
Washington D.C., District of Columbia, United States Recruiting -
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, United States Recruiting -
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida, United States Recruiting -
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States Recruiting -
Nicklaus Children's Hospital
Miami, Florida, United States Recruiting -
Arnold Palmer Hospital for Children
Orlando, Florida, United States Recruiting -
Nemours Children's Hospital
Orlando, Florida, United States Recruiting -
Nemours Children's Clinic - Pensacola
Pensacola, Florida, United States Recruiting -
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, United States Recruiting -
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa, Florida, United States Recruiting -
Children's Healthcare of Atlanta - Arthur M Blank Hospital
Atlanta, Georgia, United States Recruiting -
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States Recruiting -
Saint Luke's Cancer Institute - Boise
Boise, Idaho, United States Recruiting -
Lurie Children's Hospital-Chicago
Chicago, Illinois, United States Recruiting -
University of Illinois
Chicago, Illinois, United States Recruiting -
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States Recruiting -
Loyola University Medical Center
Maywood, Illinois, United States Recruiting -
Riley Hospital for Children
Indianapolis, Indiana, United States Recruiting -
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, United States Recruiting -
Norton Children's Hospital
Louisville, Kentucky, United States Recruiting -
Maine Children's Cancer Program
Scarborough, Maine, United States Recruiting -
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States Recruiting -
Dana-Farber Cancer Institute
Boston, Massachusetts, United States Recruiting -
C S Mott Children's Hospital
Ann Arbor, Michigan, United States Recruiting -
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, Michigan, United States Recruiting -
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, United States Recruiting -
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, United States Recruiting -
Mayo Clinic in Rochester
Rochester, Minnesota, United States Recruiting -
University of Mississippi Medical Center
Jackson, Mississippi, United States Recruiting -
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, United States Recruiting -
Cardinal Glennon Children's Medical Center
St Louis, Missouri, United States Recruiting -
Washington University School of Medicine
St Louis, Missouri, United States Recruiting -
Children's Hospital and Medical Center of Omaha
Omaha, Nebraska, United States Recruiting -
University of Nebraska Medical Center
Omaha, Nebraska, United States Recruiting -
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada, United States Recruiting -
Summerlin Hospital Medical Center
Las Vegas, Nevada, United States Recruiting
+65 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Principal investigator: Mohamed S Abdelbaki — Children's Oncology Group
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.