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| Sponsored by: |
National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00001217 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteosarcoma |
Drug: pre-surgical chemotherapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Efficacy Study |
| Official Title: | 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 |
| Estimated Enrollment: | 260 |
| Study Start Date: | May 1987 |
| Estimated Study Completion Date: | December 2000 |
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
| Study ID Numbers: | 870068, 87-C-0068 |
| Study First Received: | November 3, 1999 |
| Last Updated: | March 3, 2008 |
| ClinicalTrials.gov Identifier: | NCT00001217 |
| Health Authority: | United States: Federal Government |
|
Non-Metastatic Osteosarcoma Presurgical Chemotherapy |
|
Neoplasms, Connective and Soft Tissue Malignant mesenchymal tumor Sarcoma |
Osteosarcoma Osteogenic sarcoma Soft tissue sarcomas |
|
Neoplasms Neoplasms by Histologic Type Neoplasms, Bone Tissue Neoplasms, Connective Tissue |
