Phase I Trial of Neoadjuvant Chemoradiation with Gemcitabine and Surgical Resection for Cholangiocarcinoma Patients (NACRAC Study)

被引：33

作者：

Katayose, Yu

Rikiyama, Toshiki ^{[1
]}

Motoi, Fuyuhiko ^{[1
]}

Yamamoto, Kuniharu ^{[1
]}

Yoshida, Hiroshi ^{[1
]}

Morikawa, Takanori ^{[1
]}

Hayashi, Hiroki ^{[1
]}

Kanno, Atsushi ^{[2
]}

Hirota, Morihisa ^{[2
]}

Satoh, Kennichi ^{[2
]}

Ariga, Hisanori ^{[3
]}

Suzuki, Masaki ^{[4
]}

Ohyauchi, Motoki ^{[5
]}

Kondo, Yutaka ^{[6
]}

Ikeya, Shinichi ^{[7
]}

Ogawa, Yoshihiro ^{[3
]}

Shimosegawa, Tooru ^{[2
]}

Egawa, Shinichi ^{[1
]}

Unno, Michiaki ^{[1
]}

机构：

[1] Tohoku Univ, Div Hepatobiliary Pancreat Surg, Dept Surg, Grad Sch Med, Sendai, Miyagi 9808574, Japan

[2] Tohoku Univ, Div Gastroenterol, Grad Sch Med, Sendai, Miyagi 9808574, Japan

[3] Tohoku Univ, Dept Therapeut Radiol, Grad Sch Med, Sendai, Miyagi 9808574, Japan

[4] Miyagi Canc Ctr, Dept Gastroenterol, Natori, Miyagi 9811293, Japan

[5] Osaki Citizen Hosp, Ohsaki, Miyagi, Japan

[6] Iwate Prefectural Isawa Hosp, Ohsyu, Japan

[7] Iwaki Municipal Iwakikyouritsu Gen Hosp, Iwaki, Fukushima, Japan

来源：

HEPATO-GASTROENTEROLOGY | 2011年 / 58卷 / 112期

关键词：

Neoadjuvant; Chemoradiation; Cholangiocarcinoma; Gemcitabine; Phase I; ORTHOTOPIC LIVER-TRANSPLANTATION; ROW COMPUTED-TOMOGRAPHY; BILE-DUCT CARCINOMA; HILAR CHOLANGIOCARCINOMA; CANCER-PATIENTS; BILIARY CANCER; HEPATECTOMY; COMPLICATIONS; CHEMOTHERAPY; EXTENSION;

D O I：

10.5754/hge10106

中图分类号：

R57 [消化系及腹部疾病];

学科分类号：

摘要：

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.

引用

页码：1866 / 1872

页数：7

共 30 条

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