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

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.

Timeline

Start

1992-06

Primary completion

—

Completion

2001-03

Publications

• Background Lawrence W Jr, Donegan WL, Natarajan N, Mettlin C, Beart R, Winchester D. Adult soft tissue sarcomas. A pattern of care survey of the American College of Surgeons. Ann Surg. 1987 Apr;205(4):349-59. doi: 10.1097/00000658-198704000-00003.
• Background Alvegard TA, Sigurdsson H, Mouridsen H, Solheim O, Unsgaard B, Ringborg U, Dahl O, Nordentoft AM, Blomqvist C, Rydholm A, et al. Adjuvant chemotherapy with doxorubicin in high-grade soft tissue sarcoma: a randomized trial of the Scandinavian Sarcoma Group. J Clin Oncol. 1989 Oct;7(10):1504-13. doi: 10.1200/JCO.1989.7.10.1504.
• Background Chang AE, Kinsella T, Glatstein E, Baker AR, Sindelar WF, Lotze MT, Danforth DN Jr, Sugarbaker PH, Lack EE, Steinberg SM, et al. Adjuvant chemotherapy for patients with high-grade soft-tissue sarcomas of the extremity. J Clin Oncol. 1988 Sep;6(9):1491-500. doi: 10.1200/JCO.1988.6.9.1491.

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Indications