Preoperative and postoperative chemotherapy with ifosfamide and adriamycin for adult high-grade soft-tissue sarcomas in the extremities: Japan Clinical Oncology Group Study JCOG0304.

This phase II clinical trial aims to evaluate the efficacies and toxicities of pre- and postoperative chemotherapy with adriamycin plus ifosfamide on the patients with soft-tissue high-grade sarcomas. Patients who have operable, non-round cell soft-tissue sarcomas [French Federation of Cancer Center (FNCLCC) Grades 2 and 3] arising in the extremities [T2bN0M0, i.e. American Joint Committee on Cancer (AJCC) stage III] are treated by three courses of preoperative chemotherapy consisting of adriamycin and ifosfamide followed by complete resection and additional two courses of the same chemotherapy regimen. The Bone and Soft Tissue Tumor Study Group (BSTTSG) in the Japan Clinical Oncology Group (JCOG) including 26 specialized institutes will accrue 75 patients. The primary endpoint of the study is the 2-year progression-free survival rate, and secondary endpoints are response rate of the preoperative chemotherapy, 3-year progression-free survival rate, progression-free survival, overall survival and adverse events. The JCOG Clinical Trial Review Committee approved the protocol on 11 March 2004, and the study was started on 29 April 2004. Protocol amendment was approved on 18 May 2007.