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COMPLETED Phase 3

Combination Chemotherapy, PEG-Interferon Alfa-2b, and Surgery in Treating Patients With Osteosarcoma

NCT00134030 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 1,334 participants
Start Date 2005-11-14
Est. Completion 2022-09-30
Phase Phase 3

Sponsor

Children's Oncology Group

318 total trials

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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. 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 1,334 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Oncology Group, which has 318 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. 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: NCT00134030 reports 20 study locations spanning 4 distinct geographic areas — top geographies include California, Alabama, Arizona. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00134030?

The interventions under investigation include: Cisplatin (DRUG), Doxorubicin Hydrochloride (DRUG), Etoposide (DRUG), Ifosfamide (DRUG), Methotrexate (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00134030?

This trial is sponsored by Children's Oncology Group, which has 318 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial