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A phase I study of palliative chemoradiation therapy with paclitaxel and cisplatin for local symptoms due to an unresectable primary advanced or locally recurrent gastric adenocarcinoma

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Abstract

Purpose

To establish the maximum tolerated dose and dose-limiting toxicity of chemoradiation with paclitaxel (PTX) and cisplatin (CDDP) for patients with local symptoms due to unresectable primary advanced or locally recurrent gastric adenocarcinoma located at left-upper abdomen.

Methods

Chemotherapy consisted of PTX at escalating doses of 40–80 mg/m2 per day and CDDP at escalating doses of 20–25 mg/m2 per day on days 1, 15, and 29. Concurrent radiation was administered up to a dose of 45 Gy for 5 weeks.

Results

A total of nine patients were enrolled, of which six were into level 1 (PTX 60 mg/m2 and CDDP 20 mg/m2) and three into level −1 (PTX 50 mg/m2 and CDDP 20 mg/m2). At level 1, one patient developed grade 3 fatigue, and the other experienced grade 5 DIC, grade 5 pneumonia, grade 4 thrombocytopenia, grade 3 hyponatremia, and grade 3 esophagitis as dose-limiting toxicities. A palliative effect was observed in eight of nine patients; six of six patients at level 1 and two of three at level −1.

Conclusion

PTX 50 mg/m2 and CDDP 20 mg/m2 given biweekly with concurrent radiation therapy of 45 Gy were well tolerated.

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Acknowledgments

This study was supported by Nonprofit Organization ECRIN, Kanagawa Health Foundation, and Cancer Foundation of Kanagawa Prefectural Hospital. We greatly thank the members of the ECRIN data center and operations office for data management. We also thank following doctors for great contribution to this trial and radiation treatment: Kosuke Yamashita, M.D. and Masato Sugiyama, M.D., Department of Radiation Oncology, Kanagawa Cancer Center, Yokohama, Japan; Yukio Akagi, M.D., Department of Radiation Oncology, Hiroshima City Asa Hospital, Hiroshima, Japan; Yoshiyuki Ito, M.D., Department of Radiation Oncology, Nagoya University, Nagoya, Japan; Hajime Imada, M.D., Department of Radiation Oncology, University of Occupational and Environmental Health, Kitakyusyu, Japan, and Masao Kobayashi, M.D., Department of Radiation Oncology, Jikei University, Tokyo, Japan.

Conflict of interest statement

None.

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Authors and Affiliations

  1. Department of Gastrointestinal Surgery, Kanagawa Cancer Center, 1-1-2 Nakao, Asahi-Ku, Yokohama, 241-0815, Japan

    Takaki Yoshikawa & Akira Tsuburaya

  2. Department of Surgery, Hiroshima City Asa Hospital, Hiroshima, Japan

    Naoki Hirabayashi

  3. Department of Surgical Oncology, Gifu University, Gifu, Japan

    Kazuhiro Yoshida

  4. Department of Surgery I, University of Occupational and Environmental Health, Kitakyusyu, Japan

    Naoki Nagata

  5. Department of Surgery II, Nagoya University Graduate School of Medicine, Nagoya, Japan

    Yasuhiro Kodera

  6. Department of Surgery, Jikei University School of Medicine, Tokyo, Japan

    Naoto Takahashi

  7. EBM Research Center, Kyoto University Graduate School of Medicine, Kyoto, Japan

    Koji Oba

  8. Department of Surgery, St. Marianna University School of Medicine, Kawasaki, Japan

    Masayuki Kimura

  9. Clinical Trials and Practice Support Division, Center for Cancer Control and Information Services, National Cancer Center, Tokyo, Japan

    Satoshi Ishikura

  10. Data Center, Nonprofit Organization ECRIN, Aichi, Japan

    Yumi Miyashita

  11. Young Leaders’ Program, Nagoya University Graduate School of Medicine, Nagoya, Japan

    Junichi Sakamoto

Authors
  1. Takaki Yoshikawa
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  2. Akira Tsuburaya
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  3. Naoki Hirabayashi
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  4. Kazuhiro Yoshida
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  5. Naoki Nagata
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  6. Yasuhiro Kodera
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  7. Naoto Takahashi
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  8. Koji Oba
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  9. Masayuki Kimura
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  10. Satoshi Ishikura
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  11. Yumi Miyashita
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  12. Junichi Sakamoto
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Corresponding author

Correspondence to Takaki Yoshikawa.

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Yoshikawa, T., Tsuburaya, A., Hirabayashi, N. et al. A phase I study of palliative chemoradiation therapy with paclitaxel and cisplatin for local symptoms due to an unresectable primary advanced or locally recurrent gastric adenocarcinoma. Cancer Chemother Pharmacol 64, 1071–1077 (2009). https://doi.org/10.1007/s00280-009-0963-3

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  • DOI: https://doi.org/10.1007/s00280-009-0963-3

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