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

AbstractBACKGROUND/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/m2.
RESULTS:
One patient was not able to start treatment because of bleeding caused by a duodenal ulcer and cholangitis. At 800mg/m2 of gemcitabine, one patient out of three failed to complete the treatment because of Grade 3 hematological toxicity. In another three cases of 800mg/m2, the second case could not complete the treatment because of cholangitis. Then, 600mg/m2 was determined to be the MTD, and the RD dose decided as 600mg/m2.
CONCLUSIONS:
The RD of gemcitabine in NACRAC study was determined to be 600mg/m2. NACRAC study should proceed to a phase II trial to evaluate the effectiveness.
AuthorsYu 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
JournalHepato-gastroenterology (Hepatogastroenterology) 2011 Nov-Dec Vol. 58 Issue 112 Pg. 1866-72 ISSN: 0172-6390 [Print] Greece
PMID22234055 (Publication Type: Clinical Trial, Phase I, Journal Article)
Chemical References
  • Antimetabolites, Antineoplastic
  • Deoxycytidine
  • Gemcitabine
Topics
  • Aged
  • Antimetabolites, Antineoplastic (therapeutic use)
  • Bile Duct Neoplasms (pathology, therapy)
  • Bile Ducts, Intrahepatic
  • Chemoradiotherapy
  • Cholangiocarcinoma (pathology, therapy)
  • Deoxycytidine (adverse effects, analogs & derivatives, therapeutic use)
  • Female
  • Humans
  • Male
  • Middle Aged
  • Neoadjuvant Therapy
  • Gemcitabine

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