- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00001217
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
Study Overview
Detailed Description
Study Type
Enrollment
Phase
- Phase 3
Contacts and Locations
Study Locations
-
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Maryland
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Bethesda, Maryland, United States, 20892
- National Cancer Institute (NCI)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Rosen G, Caparros B, Huvos AG, Kosloff C, Nirenberg A, Cacavio A, Marcove RC, Lane JM, Mehta B, Urban C. Preoperative chemotherapy for osteogenic sarcoma: selection of postoperative adjuvant chemotherapy based on the response of the primary tumor to preoperative chemotherapy. Cancer. 1982 Mar 15;49(6):1221-30. doi: 10.1002/1097-0142(19820315)49:63.0.co;2-e.
- Winkler K, Beron G, Kotz R, Salzer-Kuntschik M, Beck J, Beck W, Brandeis W, Ebell W, Erttmann R, Gobel U, et al. Neoadjuvant chemotherapy for osteogenic sarcoma: results of a Cooperative German/Austrian study. J Clin Oncol. 1984 Jun;2(6):617-24. doi: 10.1200/JCO.1984.2.6.617.
- Link MP, Goorin AM, Miser AW, Green AA, Pratt CB, Belasco JB, Pritchard J, Malpas JS, Baker AR, Kirkpatrick JA, et al. The effect of adjuvant chemotherapy on relapse-free survival in patients with osteosarcoma of the extremity. N Engl J Med. 1986 Jun 19;314(25):1600-6. doi: 10.1056/NEJM198606193142502.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 870068
- 87-C-0068
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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