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

doi:10.5754/hge10106

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

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Abstract

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 language	English
Pages (from-to)	1866-1872
Number of pages	7
Journal	Hepato-Gastroenterology
Volume	58
Issue number	112
DOIs	https://doi.org/10.5754/hge10106
Publication status	Published - 2011 Nov

Keywords

Chemoradiation
Cholangiocarcinoma
Gemcitabine
Neoadjuvant
Phase I

ASJC Scopus subject areas

Hepatology
Gastroenterology

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10.5754/hge10106

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Katayose, Y., Rikiyama, T., Motoi, F., Yamamoto, K., Yoshida, H., Morikawa, T., Hayashi, H., Kanno, A., Hirota, M., Satoh, K., Ariga, H., Suzuki, M., Ohyauchi, M., Kondo, Y., Ikeya, S., Ogawa, Y., Shimosegawa, T., Egawa, S., & Unno, M. (2011). Phase I trial of neoadjuvant chemoradiation with gemcitabine and surgical resection for cholangiocarcinoma patients (NACRAC Study). Hepato-Gastroenterology, 58(112), 1866-1872. https://doi.org/10.5754/hge10106

Katayose, Y, Rikiyama, T, Motoi, F, Yamamoto, K, Yoshida, H, Morikawa, T, Hayashi, H, Kanno, A, Hirota, M, Satoh, K, Ariga, H, Suzuki, M, Ohyauchi, M, Kondo, Y, Ikeya, S, Ogawa, Y, Shimosegawa, T, Egawa, S & Unno, M 2011, 'Phase I trial of neoadjuvant chemoradiation with gemcitabine and surgical resection for cholangiocarcinoma patients (NACRAC Study)', Hepato-Gastroenterology, vol. 58, no. 112, pp. 1866-1872. https://doi.org/10.5754/hge10106

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

abstract = "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.",

keywords = "Chemoradiation, Cholangiocarcinoma, Gemcitabine, Neoadjuvant, Phase I",

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

year = "2011",

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doi = "10.5754/hge10106",

language = "English",

volume = "58",

pages = "1866--1872",

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T1 - Phase I trial of neoadjuvant chemoradiation with gemcitabine and surgical resection for cholangiocarcinoma patients (NACRAC Study)

AU - Katayose, Yu

AU - Rikiyama, Toshiki

AU - Motoi, Fuyuhiko

AU - Yamamoto, Kuniharu

AU - Yoshida, Hiroshi

AU - Morikawa, Takanori

AU - Hayashi, Hiroki

AU - Kanno, Atsushi

AU - Hirota, Morihisa

AU - Satoh, Kennichi

AU - Ariga, Hisanori

AU - Suzuki, Masaki

AU - Ohyauchi, Motoki

AU - Kondo, Yutaka

AU - Ikeya, Shinichi

AU - Ogawa, Yoshihiro

AU - Shimosegawa, Tooru

AU - Egawa, Shinichi

AU - Unno, Michiaki

PY - 2011/11

Y1 - 2011/11

N2 - 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.

AB - 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.

KW - Chemoradiation

KW - Cholangiocarcinoma

KW - Gemcitabine

KW - Neoadjuvant

KW - Phase I

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

Abstract

Keywords

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