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Randomized study. All patients must be randomized to treatment on Arms I and II within 3 months of definitive surgery on Regimen A.
Regimen A: Surgery followed, as indicated, by Radiotherapy. Amputation; or limb-sparing resection followed by involved-field irradiation using megavoltage equipment with or without electron boost.
Arm I: 2-Drug Combination Chemotherapy with Hematologic Toxicity Attenuation and Urothelial Protection. Doxorubicin, DOX, NSC-123127; Ifosfamide, IFF, NSC-109724; with Granulocyte Colony Stimulating Factor (Amgen), G-CSF,
NSC-614629; and Mesna, NSC-113891.
Arm II: Observation. No adjuvant chemotherapy.
Patients with primary, high-grade soft tissue sarcoma of the extremities will undergo treatment of their primary tumor with either amputation or limb-sparing surgery and radiotherapy, and then be randomized to either observation or adjuvant treatment with doxorubicin and ifosfamide with mesna (with G-CSF) for five cycles beginning post-operatively. Local recurrence, disease-free survival and overall survival will be evaluated in this randomized two-arm trial.
Endpoint Classification: Efficacy Study, Primary Purpose: Treatment
doxorubicin, ifosfamide, mesna
National Cancer Institute (NCI)
National Institutes of Health Clinical Center (CC)
Published on BioPortfolio: 2014-08-27T03:59:41-0400
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A sulfhydryl compound used to prevent urothelial toxicity by inactivating metabolites from ANTINEOPLASTIC AGENTS, such as IFOSFAMIDE or CYCLOPHOSPHAMIDE.
Antineoplastic antibiotic obtained from Streptomyces peucetius. It is a hydroxy derivative of DAUNORUBICIN.
An anthracycline which is the 4'-epi-isomer of doxorubicin. The compound exerts its antitumor effects by interference with the synthesis and function of DNA.
Positional isomer of CYCLOPHOSPHAMIDE which is active as an alkylating agent and an immunosuppressive agent.
An experimental sarcoma of mice.
Surgery is a technology consisting of a physical intervention on tissues. All forms of surgery are considered invasive procedures; so-called "noninvasive surgery" usually refers to an excision that does not penetrate the structure being exci...
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...
The Top 100 Pharmaceutical Companies
Top 10 biotech and pharmaceutical companies worldwide based on market value in 2015 2015 ranking of the global top 10 biotech and pharmaceutical companies based on revenue (in billion U.S. dollars) Johnson & Johnson, U.S. 74...