Preoperative and Postoperative Chemotherapy with Ifosfamide and Adriamycin for Adult High-grade Soft-tissue Sarcomas in the Extremities: Japan Clinical Oncology Group Study JCOG0304
Preoperative and Postoperative Chemotherapy with Ifosfamide and Adriamycin for Adult High-grade Soft-tissue Sarcomas in the Extremities: Japan Clinical Oncology Group Study JCOG0304
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DOI：
10.1093/jjco/hyn153
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发表时间：
2009-04-01
影响因子：
2.4
通讯作者：
Iwamoto, Yukihide
中科院分区：
文献类型：
--
作者：
Tanaka, Kazuhiro;Kawamoto, Hiroshi;Iwamoto, Yukihide
该II期临床试验旨在评估阿霉素联合异环磷酰胺术前和术后化疗对软组织高级别肉瘤患者的疗效和毒性。对于四肢出现可手术的非圆形细胞软组织肉瘤 [法国癌症联合会 (FNCCLCC) 2 级和 3 级] [T2bN0M0，即美国癌症联合委员会 (AJCC) III 期] 的患者，接受由阿霉素和异环磷酰胺组成的三个疗程的术前化疗，随后进行完全切除，并另外接受两个疗程的相同化疗方案。日本临床肿瘤学组 (JCOG) 下属的骨和软组织肿瘤研究组 (BSTTSG) 包括 26 个专业机构，将招募 75 名患者。该研究的主要终点是2年无进展生存率，次要终点是术前化疗的有效率、3年无进展生存率、无进展生存率、总生存率和不良事件。 JCOG临床试验审查委员会于2004年3月11日批准了该方案，研究于2004年4月29日开始。方案修正案于2007年5月18日获得批准。
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.