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Combination Chemotherapy With or Without Ganitumab in Treating Patients With Newly Diagnosed Metastatic Ewing Sarcoma
NCT02306161 · View on ClinicalTrials.gov ↗
Study Summary
This randomized phase III trial studies how well combination chemotherapy with or without ganitumab works in treating patients with newly diagnosed Ewing sarcoma that has spread to other parts of the body. Treatment with drugs that block the IGF-1R pathway, such as ganitumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as vincristine, doxorubicin, cyclophosphamide, ifosfamide, and etoposide, 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. It is not yet known whether adding ganitumab to combination chemotherapy is more effective in treating patients with newly diagnosed metastatic Ewing sarcoma.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Doxorubicin
- DRUG Doxorubicin Hydrochloride
- DRUG Etoposide
- DRUG Etoposide Phosphate
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
- 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
Arizona
- Banner Children's at Desert — Mesa
- Phoenix Childrens Hospital — Phoenix
- Banner University Medical Center - Tucson — Tucson
- Onvida Health Yuma Medical Center — Yuma
Alabama
- Children's Hospital of Alabama — Birmingham
- USA Health Strada Patient Care Center — Mobile
Arkansas
- CHI Saint Vincent Cancer Center Hot Springs — Hot Springs
- Arkansas Children's Hospital — Little Rock
Alaska
- Providence Alaska Medical Center — Anchorage
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 312 participants |
| Start Date | 2014-12-12 |
| Est. Completion | 2026-09-17 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02306161
The ClinicalTrials.gov registry entry for NCT02306161 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 312 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 6 conditions, with Metastatic Malignant Neoplasm in the Bone appearing as the primary indexed condition, and to 5 interventions — of which Cyclophosphamide is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02306161 reports 20 study locations spanning 5 distinct geographic areas — top geographies include California, Arizona, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02306161 about?
NCT02306161 is a clinical study titled "Combination Chemotherapy With or Without Ganitumab in Treating Patients With Newly Diagnosed Metastatic Ewing Sarcoma". This randomized phase III trial studies how well combination chemotherapy with or without ganitumab works in treating patients with newly diagnosed Ewing sarcoma that has spread to other parts of the body. Treatment with drugs that block the IGF-1R pathway, such as ganitumab, may interfere with the ...
What is the current status of trial NCT02306161?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 312 participants. The study started on 2014-12-12. Estimated completion is 2026-09-17.
What conditions does trial NCT02306161 study?
This clinical trial studies the following conditions: Metastatic Malignant Neoplasm in the Bone, Metastatic Malignant Neoplasm in the Lung, Metastatic Ewing Sarcoma, Metastatic Malignant Neoplasm in the Bone Marrow, Metastatic Peripheral Primitive Neuroectodermal Tumor of Bone. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02306161?
The interventions under investigation include: Cyclophosphamide (DRUG), Doxorubicin (DRUG), Doxorubicin Hydrochloride (DRUG), Etoposide (DRUG), Etoposide Phosphate (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02306161?
This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02306161 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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