Phase I Trial of Neoadjuvant Chemoradiation with Gemcitabine and Surgical Resection for Cholangiocarcinoma Patients (NACRAC Study)
Phase I Trial of Neoadjuvant Chemoradiation with Gemcitabine and Surgical Resection for Cholangiocarcinoma Patients (NACRAC Study)
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DOI：
10.5754/hge10106
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发表时间：
2011-11-01
影响因子：
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通讯作者：
Unno, Michiaki
中科院分区：
文献类型：
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作者：
Katayose, Yu;Rikiyama, Toshiki;Unno, Michiaki
背景/目标：新辅助放化疗治疗胆管癌的可行性，其次是传统的切除术，尚未确定。在此，进行了一项名为NACRAC的新辅助放化疗的I期研究，以确定吉西他滨联合外照射放疗治疗可切除胆管癌时的最大耐受剂量（MTD）和推荐剂量（RD）。方法：从2007年8月至2008年6月，12例患者提供了知情同意书。术前放射剂量为1.8Gy/d，总剂量为45 Gy。吉西他滨在第8天给药，每三周一次。吉西他滨的初始剂量从400 mg/m2（.）结果：1例患者由于十二指肠溃疡和胆管炎引起的出血而无法开始治疗。在800 mg/m2的吉西他滨剂量下，三分之一的患者因3级血液学毒性而未能完成治疗。在另外3例800 mg/m2的病例中，第2例因胆管炎无法完成治疗。然后，确定600 mg/m2为MTD，RD剂量确定为600 mg/m2。结论：NACRAC研究中吉西他滨的RD确定为600 mg/m2。NACRAC研究应进入II期试验，以评估有效性。
Background/Aims: The feasibility of neoadjuvant chemoradiation therapy for cholangiocarcinoma, followed by conventional resection, has not been determined yet. Here, a phase I study of neoadjuvant chemoradiation therapy, named NACRAC, was performed to determine the maximum tolerated dose (MTD) and the recommended dose (RD) of gemcitabine when combined with external beam radiation therapy for resectable cholangiocarcinoma. Methodology: From August 2007 to June 2008, 12 patients provided informed consent. Preoperative radiation was administered in 1.8Gy daily fractions up to a total dose of 45Gy. Gemcitabine was administered at day land 8 every three weeks. The initial dose of gemcitabine was started from 400mg/m2(.) Results: One patient was not able to start treatment because of bleeding caused by a duodenal ulcer and cholangitis. At 800mg/m(2) of gemcitabine, one patient out of three failed to complete the treatment because of Grade 3 hematological toxicity. In another three cases of 800mg/m(2), the second case could not complete the treatment because of cholangitis. Then, 600mg/m(2) was determined to be the MTD, and the RD dose decided as 600mg/m(2). Conclusions: The RD of gemcitabine in NACRAC study was determined to be 600mg/m(2). NACRAC study should proceed to a phase II trial to evaluate the effectiveness.