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

National Cancer Institute (NCI)

Status and phase: Completed; Phase 3

Conditions: Osteosarcoma

Treatments: Drug: pre-surgical chemotherapy

Study type: Interventional

Funder types: NIH

Identifiers

NCT00001217

870068

87-C-0068

Details and patient eligibility

About

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.

Full 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 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.

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.