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NCT01602666 · ClinicalTrials.gov registry record · Phase 2
Chemotherapy Followed by Radiation Therapy in Treating Younger Patients With Newly Diagnosed Localized Central Nervous System Germ Cell Tumors
A Phase 2 study of Central Nervous System Nongerminomatous Germ Cell Tumor and Childhood Germinoma, sponsored by Children's Oncology Group.
- Completed
- Registry status
- Phase 2
- Development phase
- 262
- Enrollment target
- 20
- Study locations
NCT01602666: Completed Phase 2 study of Central Nervous System Nongerminomatous Germ Cell Tumor and Childhood Germinoma, sponsored by Children's Oncology Group.
NCT01602666 is a Phase 2 study of Central Nervous System Nongerminomatous Germ Cell Tumor and Childhood Germinoma that has completed, run by Children's Oncology Group. The registered enrollment target is 262 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01602666, a Phase 2 study of Central Nervous System Nongerminomatous Germ Cell Tumor and Childhood Germinoma, has completed, sponsored by Children's Oncology Group.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 262 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial studies how well chemotherapy followed by radiation therapy work in treating younger patients with newly diagnosed central nervous system germ cell tumors that have not spread to other parts of the brain, spinal canal, or body (localized). Drugs used as chemotherapy, such as carboplatin, etoposide, and ifosfamide, 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 to kill tumor cells. Giving chemotherapy followed by radiation therapy may kill more tumor cells.
Primary Outcome
Binomial estimate of the 3-year PFS rate defined as "Yes" for patients who were followed up per protocol and were progression free at 3-years, and "No" for those who either experienced a progression or were lost to follow-up/withdrew from the trial within 3 years from enrollment. Progression was determined by MRI using the COG Guidelines for Measurement of Tumor Size (\>25% increase in 2D or \>40% in 3D of the product of perpendicular diameters of the target lesion) as well as by tumor marker as
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Etoposide
- RADIATION Intensity-Modulated Radiation Therapy
- DRUG Ifosfamide
- RADIATION 3-Dimensional Conformal Radiation Therapy
Study Locations (20)
California
- Kaiser Permanente Downey Medical Center - Downey
- Miller Children's and Women's Hospital Long Beach - Long Beach
- Children's Hospital Los Angeles - Los Angeles
- Cedars Sinai Medical Center - Los Angeles
- Mattel Children's Hospital UCLA - Los Angeles
- Valley Children's Hospital - Madera
- UCSF Benioff Children's Hospital Oakland - Oakland
- Kaiser Permanente-Oakland - Oakland
- Children's Hospital of Orange County - Orange
- Lucile Packard Children's Hospital Stanford University - Palo Alto
- Sutter Medical Center Sacramento - Sacramento
- Rady Children's Hospital - San Diego - San Diego
- UCSF Medical Center-Parnassus - San Francisco
- UCSF Medical Center-Mission Bay - San Francisco
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center - Torrance
Alabama
- Children's Hospital of Alabama - Birmingham
- University of Alabama at Birmingham Cancer Center - Birmingham
Arizona
- Phoenix Childrens Hospital - Phoenix
Colorado
- Children's Hospital Colorado - Aurora
Connecticut
- Connecticut Children's Medical Center - Hartford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 262 participants |
| Start Date | 2012-06-27 |
| Est. Completion | 2024-09-30 |
| Phase | Phase 2 |
What the finished NCT01602666 record still lists
NCT01602666 is an interventional study that assigns participants to a tested intervention. The registered 262 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 (97% higher).
The record links to 2 conditions, with Central Nervous System Nongerminomatous Germ Cell Tumor appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.
NCT01602666 names 20 study sites across 5 states, led by California, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT01602666 about?
NCT01602666 is a clinical study titled "Chemotherapy Followed by Radiation Therapy in Treating Younger Patients With Newly Diagnosed Localized Central Nervous System Germ Cell Tumors". This phase II trial studies how well chemotherapy followed by radiation therapy work in treating younger patients with newly diagnosed central nervous system germ cell tumors that have not spread to other parts of the brain, spinal canal, or body (localized). Drugs used as chemotherapy, such as carb...
What is the current status of trial NCT01602666?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 262 participants. The study started on 2012-06-27. Estimated completion is 2024-09-30.
What conditions does trial NCT01602666 study?
This clinical trial studies the following conditions: Central Nervous System Nongerminomatous Germ Cell Tumor, Childhood Germinoma.
What interventions are being tested in trial NCT01602666?
The interventions under investigation include: Carboplatin (DRUG), Etoposide (DRUG), Intensity-Modulated Radiation Therapy (RADIATION), Ifosfamide (DRUG), 3-Dimensional Conformal Radiation Therapy (RADIATION).
Who is sponsoring clinical trial NCT01602666?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01602666 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01602666's enrollment target sits among peer trials
262 210th of 2000 higher than 1,791 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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