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NCT01096368 · ClinicalTrials.gov registry record · Phase 3
Maintenance Chemotherapy or Observation Following Induction Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Ependymoma
A Phase 3 study of Ependymoma and Anaplastic Ependymoma, sponsored by Children's Oncology Group.
- Active
- Registry status
- Phase 3
- Development phase
- 479
- Enrollment target
- 20
- Study locations
NCT01096368 is a Phase 3 study of Ependymoma and Anaplastic Ependymoma that is active but no longer recruiting, run by Children's Oncology Group. The registered enrollment target is 479 participants, above the 81-participant average among 20 other Ependymoma trials with a reported enrollment target (491% higher). The trial reports 20 study locations across 4 states.
The verdict
NCT01096368, a Phase 3 study of Ependymoma and Anaplastic Ependymoma, is active but no longer recruiting, sponsored by Children's Oncology Group.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 479 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary aim of this randomized phase III trial was to study whether the addition of maintenance chemotherapy delivered after surgical resection and focal radiation would be better than surgery and focal radiation alone. The trial also studied if patients who received induction chemotherapy and then either achieved a complete response or went on to have a complete resection would also benefit from maintenance chemotherapy. Children ages 1-21 years with newly diagnosed intracranial ependymoma were included. There were 2 arms that were not randomized. One arm studied patients with Grade II tumors located in the supratentorial compartment that were completely resected. One arm studied patients with residual tumor and those patients all received maintenance chemotherapy after focal radiation. Chemotherapy drugs, such as vincristine sulfate, carboplatin, cyclophosphamide, etoposide, and cisplatin, 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. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving chemotherapy in combination with radiation therapy may kill more tumor cells and allow doctors to save the part of the body where the cancer started.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Carboplatin
- DRUG Cisplatin
- OTHER Clinical Observation
- RADIATION 3-Dimensional Conformal Radiation Therapy
Study Locations (20)
California
- Kaiser Permanente Downey Medical Center - Downey
- City of Hope Comprehensive Cancer Center - Duarte
- 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
- Cedars Sinai Medical Center - 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
- University of California Davis Comprehensive Cancer Center - Sacramento
Arizona
- Banner Children's at Desert - Mesa
- Phoenix Childrens Hospital - Phoenix
- Banner University Medical Center - Tucson - Tucson
Alabama
- Children's Hospital of Alabama - Birmingham
- University of Alabama at Birmingham Cancer Center - Birmingham
Arkansas
- Arkansas Children's Hospital - Little Rock
- University of Arkansas for Medical Sciences - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 479 participants |
| Start Date | 2010-05-07 |
| Est. Completion | 2026-03-31 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01096368
The ClinicalTrials.gov registry entry for NCT01096368 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 479 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 81-participant average among 20 other Ependymoma trials with a reported enrollment target (491% higher). The listed sponsor is Children's Oncology Group, which has 342 total studies on file at ClinicalTrials.gov.
The record links to 6 conditions, with Ependymoma appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT01096368 reports 20 study locations spanning 4 distinct geographic areas - top geographies include California, Arizona, Alabama.
Frequently Asked Questions
What is clinical trial NCT01096368 about?
NCT01096368 is a clinical study titled "Maintenance Chemotherapy or Observation Following Induction Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Ependymoma". The primary aim of this randomized phase III trial was to study whether the addition of maintenance chemotherapy delivered after surgical resection and focal radiation would be better than surgery and focal radiation alone. The trial also studied if patients who received induction chemotherapy and t...
What is the current status of trial NCT01096368?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 479 participants. The study started on 2010-05-07. Estimated completion is 2026-03-31.
What conditions does trial NCT01096368 study?
This clinical trial studies the following conditions: Ependymoma, Anaplastic Ependymoma, Brain Ependymoma, Cellular Ependymoma, Clear Cell Ependymoma.
What interventions are being tested in trial NCT01096368?
The interventions under investigation include: Cyclophosphamide (DRUG), Carboplatin (DRUG), Cisplatin (DRUG), Clinical Observation (OTHER), 3-Dimensional Conformal Radiation Therapy (RADIATION).
Who is sponsoring clinical trial NCT01096368?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01096368 being conducted?
This trial has 20 study locations across Alabama, 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.