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ARTIST

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

Phase 3N = 458NCT00323830

Population
Patients with completely resected gastric cancer after D2 lymph node dissection.
Design
Randomised phase 3 comparison after D2 gastrectomy: six cycles of capecitabine plus cisplatin (XP), or two cycles of XP followed by 45 Gy radiotherapy with concurrent capecitabine and then two further cycles of XP. The abstract reports 458 patients randomised (228 and 230) and names a planned follow-up trial (ARTIST-II) in node-positive disease. Registered on ClinicalTrials.gov as NCT00323830 (Samsung Medical Center).
Arms
  • Chemotherapy alone (XP) (control, n = 228): Six cycles of capecitabine plus cisplatin
  • Chemotherapy with chemoradiotherapy (XP/XRT/XP) (experimental, n = 230): Two cycles XP, 45 Gy radiotherapy with capecitabine, two cycles XP
People
Lee J, senior author Kang WK
DFSHR 0.6865 (95% CI 0.4735–0.9952)
Show the numbers
Results reported for ARTIST
EndpointAnalysisChemotherapy with chemoradiotherapy (XP/XRT/XP)Chemotherapy alone (XP)Effect
DFSSubgroup with pathologic lymph node metastasis at surgery (n = 396)exploratoryLee 2012——HR 0.6865 (95% CI 0.4735–0.9952)P=0.0471A subgroup result. For all randomised patients the addition of radiotherapy did not significantly prolong disease-free survival (P = .0862); no hazard ratio is given in the abstract for that comparison. Log-rank P for the subgroup was .0365.
Results reported for ARTIST
EndpointAnalysisChemotherapy with chemoradiotherapy (XP/XRT/XP)Chemotherapy alone (XP)Effect
DFSSubgroup with pathologic lymph node metastasis at surgery (n = 396)exploratoryLee 2012——HR 0.6865 (95% CI 0.4735–0.9952)P=0.0471A subgroup result. For all randomised patients the addition of radiotherapy did not significantly prolong disease-free survival (P = .0862); no hazard ratio is given in the abstract for that comparison. Log-rank P for the subgroup was .0365.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
DFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
DFS0.68650.4735–0.9952
Primary publication: Lee J, Lim DH, Kim S, Park SH, Park JO, Park YS, et al. 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. J Clin Oncol. 2012;30(3):268-73. PubMedDOI

Appears in

Sources

  1. Lee J, Lim DH, Kim S, Park SH, Park JO, Park YS, et al. 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. J Clin Oncol. 2012;30(3):268-73.

    PubMedDOI