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NCT04684368 · ClinicalTrials.gov registry record · Phase 2
A Study of a New Way to Treat Children and Young Adults With a Brain Tumor Called NGGCT
A Phase 2 study of Choriocarcinoma and Mixed Germ Cell Tumor, sponsored by Children's Oncology Group.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 160
- Enrollment target
- 20
- Study locations
NCT04684368 is a Phase 2 study of Choriocarcinoma and Mixed Germ Cell Tumor that is actively recruiting participants, run by Children's Oncology Group. The registered enrollment target is 160 participants, below the 336-participant average among 5 other Choriocarcinoma trials with a reported enrollment target (52% lower). The trial reports 20 study locations across 6 states.
The verdict
NCT04684368, a Phase 2 study of Choriocarcinoma and Mixed Germ Cell Tumor, is actively recruiting participants, sponsored by Children's Oncology Group.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 160 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial studies the best approach to combine chemotherapy and radiation therapy (RT) based on the patient's response to induction chemotherapy in patients with non-germinomatous germ cell tumors (NGGCT) that have not spread to other parts of the brain or body (localized). This study has 2 goals: 1) optimizing radiation for patients who respond well to induction chemotherapy to diminish spinal cord relapses, 2) utilizing higher dose chemotherapy followed by conventional RT in patients who did not respond to induction chemotherapy. Chemotherapy drugs, such as carboplatin, etoposide, ifosfamide, and thiotepa, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays or high-energy protons to kill tumor cells and shrink tumors. Studies have shown that patients with newly-diagnosed localized NGGCT, whose disease responds well to chemotherapy before receiving radiation therapy, are more likely to be free of the disease for a longer time than are patients for whom the chemotherapy does not efficiently eliminate or reduce the size of the tumor. The purpose of this study is to see how well the tumors respond to induction chemotherapy to decide what treatment to give next. Some patients will be given RT to the spine and a portion of the brain. Others will be given high dose chemotherapy and a stem cell transplant before RT to the whole brain and spine. Giving treatment based on the response to induction chemotherapy may lower the side effects of radiation in some patients and adjust the therapy to a more efficient one for other patients with localized NGGCT.
Conditions Studied
Interventions
- DRUG Carboplatin
- PROCEDURE Biospecimen Collection
- DRUG Etoposide
- BIOLOGICAL Filgrastim
- DRUG Ifosfamide
Study Locations (20)
California
- Kaiser Permanente Downey Medical Center - Downey
- Loma Linda University Medical Center - Loma Linda
- Miller Children's and Women's Hospital Long Beach - Long Beach
- Children's Hospital Los Angeles - Los Angeles
- Kaiser Permanente Los Angeles Medical Center - Los Angeles
- Cedars Sinai Medical Center - Los Angeles
- Valley Children's Hospital - Madera
- Kaiser Permanente-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
Arizona
- Banner Children's at Desert - Mesa
- Phoenix Childrens Hospital - Phoenix
- Banner University Medical Center - Tucson - Tucson
- University of Arizona Cancer Center-North Campus - Tucson
Alabama
- Children's Hospital of Alabama - Birmingham
Alaska
- Providence Alaska Medical Center - Anchorage
Arkansas
- Arkansas Children's Hospital - Little Rock
Colorado
- Children's Hospital Colorado - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2021-07-13 |
| Est. Completion | 2029-12-21 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04684368
The ClinicalTrials.gov registry entry for NCT04684368 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 160 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 336-participant average among 5 other Choriocarcinoma trials with a reported enrollment target (52% lower). The listed sponsor is Children's Oncology Group, which has 342 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with Choriocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.
NCT04684368 reports 20 study locations spanning 6 distinct geographic areas - top geographies include California, Arizona, Alabama.
Frequently Asked Questions
What is clinical trial NCT04684368 about?
NCT04684368 is a clinical study titled "A Study of a New Way to Treat Children and Young Adults With a Brain Tumor Called NGGCT". This phase II trial studies the best approach to combine chemotherapy and radiation therapy (RT) based on the patient's response to induction chemotherapy in patients with non-germinomatous germ cell tumors (NGGCT) that have not spread to other parts of the brain or body (localized). This study has ...
What is the current status of trial NCT04684368?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 160 participants. The study started on 2021-07-13. Estimated completion is 2029-12-21.
What conditions does trial NCT04684368 study?
This clinical trial studies the following conditions: Choriocarcinoma, Mixed Germ Cell Tumor, Central Nervous System Nongerminomatous Germ Cell Tumor, Embryonal Carcinoma, Immature Teratoma.
What interventions are being tested in trial NCT04684368?
The interventions under investigation include: Carboplatin (DRUG), Biospecimen Collection (PROCEDURE), Etoposide (DRUG), Filgrastim (BIOLOGICAL), Ifosfamide (DRUG).
Who is sponsoring clinical trial NCT04684368?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04684368 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.