Preoperative chemotherapy for osteogenic sarcoma: selection of postoperative adjuvant chemotherapy based on the response of the primary tumor to preoperative chemotherapy.
G Rosen, B Caparros, A G Huvos...
https://pubmed.ncbi.nlm.nih.gov/6174200Completed
Phase 3
All Genders
ID00001217
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
Led by National Cancer Institute (NCI) · Updated on 2008-03-04
260
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
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
Who Can Participate
All Genders
Eligibility Criteria
You may qualify if you...
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.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 1 location
1
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892
Status Unknown
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
TREATMENT
Number of Arms
0
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Published Research Related To This Trial
Neoadjuvant chemotherapy for osteogenic sarcoma: results of a Cooperative German/Austrian study.
K Winkler, G Beron, R Kotz...
https://pubmed.ncbi.nlm.nih.gov/6202851The effect of adjuvant chemotherapy on relapse-free survival in patients with osteosarcoma of the extremity.
M P Link, A M Goorin, A W Miser...
https://pubmed.ncbi.nlm.nih.gov/3520317