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Status:

COMPLETED

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

Lead Sponsor:

Children's Oncology Group

Collaborating Sponsors:

National Cancer Institute (NCI)

University College, London

Conditions:

Localized Osteosarcoma

Metastatic Osteosarcoma

Eligibility:

All Genders

5-40 years

Phase:

PHASE3

Brief 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 ...

Detailed Description

PRIMARY OBJECTIVES: I. Compare whether adjuvant maintenance therapy comprising doxorubicin, cisplatin, and high-dose methotrexate (MAP) alone vs MAP combined with ifosfamide and etoposide improves ev...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Histologically confirmed high-grade osteosarcoma, including second malignancies
  • Localized or metastatic disease
  • The primary tumor must be located in the limbs or axial skeleton, including any of the following sites\*:
  • Long bone of upper limb
  • Short bone of upper limb
  • Long bone of lower limb
  • Short bone of lower limb
  • Vertebral column
  • Ribs, sternum, clavicle, or scapula
  • Pelvic bones, sacrum, or coccyx
  • Tumor (primary, metastatic, or both) resectable OR is expected to become resectable after neoadjuvant induction chemotherapy
  • Suitable for neoadjuvant chemotherapy
  • Performance status - Lansky 50-100% (for patients under 16 years of age)
  • Performance status - Karnofsky 50-100%\*
  • Performance status - WHO or ECOG 0-2\*
  • Platelet count ≥ 100,000/mm³
  • Neutrophil count ≥ 1,500/mm³
  • WBC ≥ 3,000/mm³
  • Bilirubin ≤ 1.5 times upper limit of normal
  • Creatinine clearance ≥ 70 mL/min
  • Creatinine based on age as follows:
  • No greater than 1.0 mg/dL (for patients 5 to 10 years of age)
  • No greater than 1.2 mg/dL (for patients 11 to 15 years of age)
  • No greater than 1.5 mg/dL (for patients over 15 years of age)
  • Ejection fraction ≥ 50% by radionuclide angiogram
  • Shortening fraction ≥ 28% by echocardiogram
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No known HIV positivity
  • No prior chemotherapy for any disease
  • Prior radiotherapy for another malignancy allowed
  • No prior treatment for osteosarcoma
  • No patients with any of the following:
  • Craniofacial osteosarcoma

Exclusion

    Key Trial Info

    Start Date :

    November 14 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    September 30 2022

    Estimated Enrollment :

    1334 Patients enrolled

    Trial Details

    Trial ID

    NCT00134030

    Start Date

    November 14 2005

    End Date

    September 30 2022

    Last Update

    June 7 2023

    Active Locations (218)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 55 (218 locations)

    1

    Children's Hospital of Alabama

    Birmingham, Alabama, United States, 35233

    2

    University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, United States, 35233

    3

    Phoenix Childrens Hospital

    Phoenix, Arizona, United States, 85016

    4

    Banner University Medical Center - Tucson

    Tucson, Arizona, United States, 85719