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首页> 外文期刊>Frontiers in bioscience: a journal and virtual library >Phase II study of neoadjuvant concurrent chemioradiotherapy with oxaliplatin-containing regimen in locally advanced rectal cancer.
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Phase II study of neoadjuvant concurrent chemioradiotherapy with oxaliplatin-containing regimen in locally advanced rectal cancer.

机译：局部晚期直肠癌新辅助化疗联合含奥沙利铂方案的II期临床研究。

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摘要

The purpose of this phase II trial was to assess tolerance and efficacy of the combination of radiation, fluorouracil and oxaliplatin as neoadjuvant treatment in locally advanced rectal cancer. Between March 2001 and August 2004 , 28 patients M/18 F/10 with locally advanced rectal cancer were entered in our study. All the patients underwent to the Radiotherapy with a total dose was 45 Gy and concurrent chemotherapy with Oxaliplatin 80 mg/mq G1 on weeks 1,3,5 followed by five day continuous infusion of 5-Fluorouracile 300 mg/mq on five consecutive weeks. Surgery was planned 5 weeks later. Surgery was performed in all patients after a mean interval time of 5 weeks. Side effects and toxicity included grade II sec WHO diarrhea and grade II mucositis , grade I-II dysuria and skin reaction Downstaging to T0-2N0 was achieved in 18 patients (65%) with 4 (15%) achieving a pathologically complete response. Conclusions: Such a combined preoperative chemioradiotherapy and oxaliplatin-containing regimen is well tolerated with non increase in surgical toxicity.The good response rate observed warrants its use in further clinical trials.
机译：这项II期临床试验的目的是评估放疗，氟尿嘧啶和奥沙利铂联合治疗局部晚期直肠癌的新辅助治疗的耐受性和疗效。在2001年3月至2004年8月之间，我们的研究纳入了28位M / 18 F / 10局部晚期直肠癌患者。所有接受放疗的患者总剂量为45 Gy，并在第1,3,5周同时用奥沙利铂80 mg / mq G1进行同步化疗，然后连续5天连续5天连续输注5-氟尿嘧啶300 mg / mq。手术计划在5周后进行。平均间隔时间为5周后，对所有患者进行手术。副作用和毒性包括II级sec WHO腹泻和II级粘膜炎，I-II级排尿困难和皮肤反应18位患者（65％）降级为T0-2N0，其中4位（15％）达到了病理完全缓解。结论：这种术前化学放疗和含奥沙利铂的联合治疗方案耐受性好，手术毒性没有增加，观察到的良好应答率值得在进一步的临床试验中使用。

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