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
pre-surgical chemotherapy
Neoplasms+4
+ Neoplasms by Histologic Type
+ Neoplasms, Connective Tissue
Treatment Study
Summary
Study start date: May 1, 1987
Actual date on which the first participant was enrolled.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 surgical procedure for their primary tumor is superior as a treatment strategy to the current approach of giving drugs only after the definitive surgical procedure has been performed. An effort will be made as well to determine if the administration of pre-definitive surgery, chemotherapy leads to an increase in the proportion of the patients suitable for a limb salvage primary surgical procedure.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.260 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
National Cancer Institute (NCI)
Bethesda, United StatesOpen National Cancer Institute (NCI) in Google Maps