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)
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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