Status:
COMPLETED
Osteosarcoma Study #2: A Randomized Trial of Pre-Surgical Chemotherapy vs. Immediate Surgery and Adjuvant Chemotherapy in the Treatment of Non-Metastatic Osteosarcoma. A Pediatric Oncology Group Phase III Study
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Osteosarcoma
Eligibility:
All Genders
Phase:
PHASE3
Brief Summary
The study is designed to determine if the administration of multi-drug adjuvant chemotherapy for patients with primary non-metastatic osteogenic sarcoma, both prior to and after the definitive surgica...
Detailed Description
The study is designed to determine if the administration of multi-drug adjuvant chemotherapy for patients with primary non-metastatic osteogenic sarcoma, both prior to and after the definitive surgica...
Eligibility Criteria
Must be less than or equal to 30 years of age.
No prior history of cancer.
No prior therapy-other than biopsy.
Informed consent according or institutional guidelines (Agreement to randomization to either presurgical chemotherapy or immediate surgery-physicians must also agree).
Less than or equal to 21 days since initial diagnosis and eligible to have surgery within 3 weeks of randomization.
Must have a high grade osteosarcoma.
Must not have low grade osteosarcoma, periosteal and parosteal
osteosarcoma, or multi-focal sclerosing of osteosarcoma.
Tumor must be confined to extremity or expendable and resectable bone of axial skeleton (i.e., ilium, scapula, clavicle, rib).
No evidence of metastases by PE, CXR, chest CT, and bone scans. (Chest CT must be normal within 2 weeks of randomization). Abnormalities on chest CT must be biopsy-negative or thoracotomy negative. Suspicious lesions on bone scan should be biopsied.
LDH level and surgical intent (i.e., amputation, resection, or limb replacement) must be known before patient is registered.
Key Trial Info
Start Date :
May 1 1987
Trial Type :
INTERVENTIONAL
End Date :
December 1 2000
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT00001217
Start Date
May 1 1987
End Date
December 1 2000
Last Update
March 4 2008
Active Locations (1)
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1
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892