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NCT00134030 · ClinicalTrials.gov registry record · Phase 3
Combination Chemotherapy, PEG-Interferon Alfa-2b, and Surgery in Treating Patients With Osteosarcoma
A Phase 3 study of Metastatic Osteosarcoma and Localized Osteosarcoma, sponsored by Children's Oncology Group.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,334
- Enrollment target
- 20
- Study locations
NCT00134030 is a Phase 3 study of Metastatic Osteosarcoma and Localized Osteosarcoma that has completed, run by Children's Oncology Group. The registered enrollment target is 1,334 participants, above the 201-participant average among 8 other Metastatic Osteosarcoma trials with a reported enrollment target (564% higher). The trial reports 20 study locations across 4 states.
The verdict
NCT00134030, a Phase 3 study of Metastatic Osteosarcoma and Localized Osteosarcoma, has completed, sponsored by Children's Oncology Group.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,334 participants
- Enrollment target
- 20
- Study locations
Study Summary
This randomized phase III trial is studying combination chemotherapy followed by surgery and two different combination chemotherapy regimens with or without PEG-interferon alfa-2b to compare how well they work in treating patients with osteosarcoma. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Biological therapies, such as PEG-interferon alfa-2b, may interfere with the growth of tumor cells. Giving combination chemotherapy before surgery may shrink the tumor so it can be removed. Giving combination chemotherapy together with PEG-interferon alfa-2b after surgery may kill any remaining tumor cells. It is not yet known whether giving combination therapy together with PEG-interferon alfa-2b is more effective than two different combination chemotherapy regimens alone after surgery in treating osteosarcoma.
Conditions Studied
Interventions
- DRUG Cisplatin
- DRUG Doxorubicin Hydrochloride
- DRUG Etoposide
- DRUG Ifosfamide
- DRUG Methotrexate
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
- Mattel Children's Hospital UCLA - Los Angeles
- UCLA / Jonsson Comprehensive Cancer Center - Los Angeles
- Valley Children's Hospital - Madera
- Children's Hospital and Research Center at 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
Alabama
- Children's Hospital of Alabama - Birmingham
- University of Alabama at Birmingham Cancer Center - Birmingham
Arizona
- Phoenix Childrens Hospital - Phoenix
- Banner University Medical Center - Tucson - Tucson
Arkansas
- Arkansas Children's Hospital - Little Rock
- University of Arkansas for Medical Sciences - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,334 participants |
| Start Date | 2005-11-14 |
| Est. Completion | 2022-09-30 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00134030
The ClinicalTrials.gov registry entry for NCT00134030 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,334 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 201-participant average among 8 other Metastatic Osteosarcoma trials with a reported enrollment target (564% higher). The listed sponsor is Children's Oncology Group, which has 342 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Metastatic Osteosarcoma appearing as the primary indexed condition, and to 5 interventions - of which Cisplatin is the first listed.
NCT00134030 reports 20 study locations spanning 4 distinct geographic areas - top geographies include California, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT00134030 about?
NCT00134030 is a clinical study titled "Combination Chemotherapy, PEG-Interferon Alfa-2b, and Surgery in Treating Patients With Osteosarcoma". This randomized phase III trial is studying combination chemotherapy followed by surgery and two different combination chemotherapy regimens with or without PEG-interferon alfa-2b to compare how well they work in treating patients with osteosarcoma. Drugs used in chemotherapy work in different ways ...
What is the current status of trial NCT00134030?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,334 participants. The study started on 2005-11-14. Estimated completion is 2022-09-30.
What conditions does trial NCT00134030 study?
This clinical trial studies the following conditions: Metastatic Osteosarcoma, Localized Osteosarcoma.
What interventions are being tested in trial NCT00134030?
The interventions under investigation include: Cisplatin (DRUG), Doxorubicin Hydrochloride (DRUG), Etoposide (DRUG), Ifosfamide (DRUG), Methotrexate (DRUG).
Who is sponsoring clinical trial NCT00134030?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00134030 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.