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Phase III Trial Comparing Capecitabine Plus Cisplatin Versus Capecitabine Plus Cisplatin With Concurrent Capecitabine Radiotherapy in Completely Resected Gastric Cancer With D2 Lymph Node Dissection: The ARTIST Trial

Lee, Jeeyun, Lim, Do Hoon, Kim, Sung, Park, Se Hoon, Park, Joon Oh, Park, Young Suk, Lim, Ho Yeong, Choi, Min Gew, Sohn, Tae Sung, Noh, Jae Hyung, Bae, Jae Moon, Ahn, Yong Chan, Sohn, Insuk, Jung, Sin Ho, Park, Cheol Keun, Kim, Kyoung-Mee, Kang, Won Ki·2012·Journal of Clinical Oncology

Abstract

Purpose: The ARTIST (Adjuvant Chemoradiation Therapy in Stomach Cancer) trial was the first study to our knowledge to investigate the role of postoperative chemoradiotherapy therapy in patients with curatively resected gastric cancer with D2 lymph node dissection. This trial was designed to compare postoperative treatment with capecitabine plus cisplatin (XP) versus XP plus radiotherapy with capecitabine (XP/XRT/XP). Patients and Methods: The XP arm received six cycles of XP (capecitabine 2,000 mg/m 2 per day on days 1 to 14 and cisplatin 60 mg/m 2 on day 1, repeated every 3 weeks) chemotherapy. The XP/XRT/XP arm received two cycles of XP followed by 45-Gy XRT (capecitabine 1,650 mg/m 2 per day for 5 weeks) and two cycles of XP. Results: Of 458 patients, 228 were randomly assigned to the XP arm and 230 to the XP/XRT/XP arm. Treatment was completed as planned by 75.4% of patients (172 of 228) in the XP arm and 81.7% (188 of 230) in the XP/XRT/XP arm. Overall, the addition of XRT to XP chemotherapy did not significantly prolong disease-free survival (DFS; P = .0862). However, in the subgroup of patients with pathologic lymph node metastasis at the time of surgery (n = 396), patients randomly assigned to the XP/XRT/XP arm experienced superior DFS when compared with those who received XP alone (P = .0365), and the statistical significance was retained at multivariate analysis (estimated hazard ratio, 0.6865; 95% CI, 0.4735 to 0.9952; P = .0471). Conclusion: The addition of XRT to XP chemotherapy did not significantly reduce recurrence after curative resection and D2 lymph node dissection in gastric cancer. A subsequent trial (ARTIST-II) in patients with lymph node–positive gastric cancer is planned.

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Metadata

Authors
Lee, J., Lim, D. H., Kim, S., Park, S. H., Park, J. O., Park, Y. S., Lim, H. Y., Choi, M. G., Sohn, T. S., Noh, J. H., Bae, J. M., Ahn, Y. C., Sohn, I., Jung, S. H., Park, C. K., Kim, K.-M., & Kang, W. K.
Venue
Journal of Clinical Oncology
Published
2012-01-20
Volume
30
Issue
3
Pages
268-273
ISSN
  • 0732-183X (ISSN-L)
  • 1527-7755
OpenAlex
W2149895338
Cited by
803
References
18
FWCI
41.08
Type
journal article
Language
en
Open access
closed

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CoChat. (2026). Citation check: Phase III Trial Comparing Capecitabine Plus Cisplatin Versus Capecitabine Plus Cisplatin With Concurrent Capecitabine Radiotherapy in Completely Resected Gastric Cancer With D2 Lymph Node Dissection: The ARTIST Trial. https://app.cochat.ai/papers/10.1200/jco.2011.39.1953
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Lee, J., Lim, D. H., Kim, S., Park, S. H., Park, J. O., Park, Y. S., Lim, H. Y., Choi, M. G., Sohn, T. S., Noh, J. H., Bae, J. M., Ahn, Y. C., Sohn, I., Jung, S. H., Park, C. K., Kim, K.-M., & Kang, W. K. (2012). Phase III Trial Comparing Capecitabine Plus Cisplatin Versus Capecitabine Plus Cisplatin With Concurrent Capecitabine Radiotherapy in Completely Resected Gastric Cancer With D2 Lymph Node Dissection: The ARTIST Trial. Journal of Clinical Oncology. https://doi.org/10.1200/jco.2011.39.1953

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

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