Phase I trial of neoadjuvant chemoradiation with gemcitabine and surgical resection for cholangiocarcinoma patients (NACRAC Study)

Yu Katayose, Toshiki Rikiyama, Fuyuhiko Motoi, Kuniharu Yamamoto, Hiroshi Yoshida, Takanori Morikawa, Hiroki Hayashi, Atsushi Kanno, Morihisa Hirota, Kennichi Satoh, Hisanori Ariga, Masaki Suzuki, Motoki Ohyauchi, Yutaka Kondo, Shinichi Ikeya, Yoshihiro Ogawa, Tooru Shimosegawa, Shinichi Egawa, Michiaki Unno

Research output: Contribution to journalArticlepeer-review

31 Citations (Scopus)


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 1 and 8 every three weeks. The initial dose of gemcitabine was started from 400mg/m 2. 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.

Original languageEnglish
Pages (from-to)1866-1872
Number of pages7
Issue number112
Publication statusPublished - 2011 Nov


  • Chemoradiation
  • Cholangiocarcinoma
  • Gemcitabine
  • Neoadjuvant
  • Phase I

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology


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