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NCT06368817 · ClinicalTrials.gov registry record · Phase 2
A Study of Lower Radiotherapy Dose to Treat Children With CNS Germinoma
A Phase 2 study of Diabetes Insipidus and Basal Ganglia Germinoma, sponsored by Children's Oncology Group.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 240
- Enrollment target
- 20
- Study locations
NCT06368817: Recruiting Phase 2 study of Diabetes Insipidus and Basal Ganglia Germinoma, sponsored by Children's Oncology Group.
NCT06368817 is a Phase 2 study of Diabetes Insipidus and Basal Ganglia Germinoma that is actively recruiting participants, run by Children's Oncology Group. The registered enrollment target is 240 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06368817, a Phase 2 study of Diabetes Insipidus and Basal Ganglia Germinoma, is actively recruiting participants, sponsored by Children's Oncology Group.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 240 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial studies how well lower dose radiotherapy after chemotherapy (Carboplatin \& Etoposide) works in treating children with central nervous system (CNS) germinomas. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill cancer cells. Researchers want to see if lowering the dose of standard radiotherapy (RT) after chemotherapy can help get rid of CNS germinomas with fewer long-term side effects.
Primary Outcome
Will be estimated for eligible and evaluable patients assigned to Stratum 1 using Kaplan-Meier (KM) EFS estimates at 2 and 3 years with respective 80% two-sided confidence intervals. Time from initiation of radiation to the first occurrence of any of the following events: biochemical or radiographic disease progression, disease recurrence, second malignant neoplasm, or death from any cause.
Conditions Studied
Interventions
- DRUG Carboplatin
- PROCEDURE Biospecimen Collection
- DRUG Etoposide
- RADIATION Intensity-Modulated Radiation Therapy
- RADIATION 3-Dimensional Conformal Radiation Therapy
Study Locations (20)
California
- Loma Linda University Medical Center - Loma Linda
- Children's Hospital Los Angeles - Los Angeles
- UCSF Benioff Children's Hospital Oakland - Oakland
- Children's Hospital of Orange County - Orange
- Lucile Packard Children's Hospital Stanford University - Palo Alto
- Rady Children's Hospital - San Diego - San Diego
- UCSF Medical Center-Mission Bay - San Francisco
Florida
- Memorial Regional Hospital/Joe DiMaggio Children's Hospital - Hollywood
- Nemours Children's Clinic-Jacksonville - Jacksonville
- University of Miami Miller School of Medicine-Sylvester Cancer Center - Miami
- Nicklaus Children's Hospital - Miami
- Arnold Palmer Hospital for Children - Orlando
- Nemours Children's Hospital - Orlando
Alabama
- USA Health Strada Patient Care Center - Mobile
Arizona
- Phoenix Childrens Hospital - Phoenix
Arkansas
- Arkansas Children's Hospital - Little Rock
Colorado
- Children's Hospital Colorado - Aurora
Connecticut
- Connecticut Children's Medical Center - Hartford
Delaware
- Alfred I duPont Hospital for Children - Wilmington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2024-10-22 |
| Est. Completion | 2033-11-04 |
| Phase | Phase 2 |
What NCT06368817 shows while recruiting
NCT06368817 is an interventional study that assigns participants to a tested intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% higher).
The record links to 6 conditions, with Diabetes Insipidus appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.
NCT06368817 names 20 study sites across 9 states, led by California, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT06368817 about?
NCT06368817 is a clinical study titled "A Study of Lower Radiotherapy Dose to Treat Children With CNS Germinoma". This phase II trial studies how well lower dose radiotherapy after chemotherapy (Carboplatin \& Etoposide) works in treating children with central nervous system (CNS) germinomas. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Carbo...
What is the current status of trial NCT06368817?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 240 participants. The study started on 2024-10-22. Estimated completion is 2033-11-04.
What conditions does trial NCT06368817 study?
This clinical trial studies the following conditions: Diabetes Insipidus, Basal Ganglia Germinoma, Central Nervous System Germinoma, Pineal Region Germinoma, Suprasellar Germinoma.
What interventions are being tested in trial NCT06368817?
The interventions under investigation include: Carboplatin (DRUG), Biospecimen Collection (PROCEDURE), Etoposide (DRUG), Intensity-Modulated Radiation Therapy (RADIATION), 3-Dimensional Conformal Radiation Therapy (RADIATION).
Who is sponsoring clinical trial NCT06368817?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06368817 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06368817's enrollment target sits among peer trials
240 239th of 2000 higher than 1,746 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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