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NCT02306161 · ClinicalTrials.gov registry record · Phase 3
Combination Chemotherapy With or Without Ganitumab in Treating Patients With Newly Diagnosed Metastatic Ewing Sarcoma
A Phase 3 study of Metastatic Malignant Neoplasm in the Bone and Metastatic Malignant Neoplasm in the Lung, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 3
- Development phase
- 312
- Enrollment target
- 20
- Study locations
NCT02306161: Active Phase 3 study of Metastatic Malignant Neoplasm in the Bone and Metastatic Malignant Neoplasm in the Lung, sponsored by National Cancer Institute (NCI).
NCT02306161 is a Phase 3 study of Metastatic Malignant Neoplasm in the Bone and Metastatic Malignant Neoplasm in the Lung that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 312 participants, above the 230-participant average among 16 other Metastatic Malignant Neoplasm in the Bone trials with a reported enrollment target (36% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02306161, a Phase 3 study of Metastatic Malignant Neoplasm in the Bone and Metastatic Malignant Neoplasm in the Lung, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 312 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Estimated 5-year EFS where EFS is calculated as the time from study enrollment to disease progression, disease relapse, occurrence of a second malignant neoplasm, death from any cause or last follow-up whichever occurs first. Kaplan-Meier method is used for estimation. Patients without an event are censored at last contact.
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 |
What the registry record for NCT02306161 still lists
NCT02306161 is an interventional study that assigns participants to a tested intervention. The registered 312 participants enrollment target is mid-sized for trials with a published cap, above the 230-participant average among 16 other Metastatic Malignant Neoplasm in the Bone trials with a reported enrollment target (36% higher).
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.
NCT02306161 names 20 study sites across 5 states, led by California, Arizona, Alabama.
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.
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).
Who is sponsoring clinical trial NCT02306161?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT02306161's enrollment target sits among peer trials
312 3rd of 16 higher than 14 of 16 other Metastatic Malignant Neoplasm in the Bone trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Malignant Neoplasm in the Bone 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.
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