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Sponsors and Collaborators: |
Mayo Clinic National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00645632 |
RATIONALE: Drugs used in chemotherapy, such as ifosfamide, methotrexate, cisplatin, and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving it after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This clinical trial is studying how well combination chemotherapy works in treating patients undergoing surgery for newly diagnosed high-grade osteosarcoma.
Condition | Intervention |
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Sarcoma |
Drug: cisplatin Drug: doxorubicin hydrochloride Drug: ifosfamide Drug: methotrexate Procedure: adjuvant therapy Procedure: neoadjuvant therapy Procedure: therapeutic conventional surgery |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Treatment of Newly Diagnosed Untreated Osteosarcoma: A Pilot Study of a New Chemotherapeutic Regimen Including Ifosfamide |
Estimated Enrollment: | 60 |
Study Start Date: | November 1990 |
Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter study.
After completion of study therapy, patients are followed every 2 months for 1 year, every 4 months for 2 years, every 6 months for 2 years, and then annually thereafter.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed osteosarcoma of the extremity
High-grade (grade III or IV) disease
PATIENT CHARACTERISTICS:
No other prior malignancy except retinoblastoma
PRIOR CONCURRENT THERAPY:
No prior chemotherapy or radiotherapy
Study ID Numbers: | CDR0000582263, MAYO-909101 |
Study First Received: | March 26, 2008 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00645632 |
Health Authority: | United States: Federal Government |
localized osteosarcoma |
Malignant mesenchymal tumor Osteosarcoma Osteogenic sarcoma Soft tissue sarcomas Doxorubicin Folic Acid Neoplasms, Connective and Soft Tissue |
Ifosfamide Cisplatin Mechlorethamine Sarcoma Methotrexate Isophosphamide mustard |
Antimetabolites Antimetabolites, Antineoplastic Neoplasms by Histologic Type Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Reproductive Control Agents Folic Acid Antagonists Antibiotics, Antineoplastic Abortifacient Agents, Nonsteroidal |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms, Bone Tissue Therapeutic Uses Abortifacient Agents Neoplasms, Connective Tissue Antineoplastic Agents, Alkylating Antirheumatic Agents Dermatologic Agents Alkylating Agents Nucleic Acid Synthesis Inhibitors |