Spots Global Cancer Trial Database for A Randomized Study of the Effect of Adjuvant Chemotherapy With Doxorubicin and Ifosfamide With Mesna in the Treatment of High-Grade Adult Extremity Soft Tissue Sarcoma

Study Description

Brief Summary: 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.

Detailed Description: 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.

Keywords

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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