A Phase II study of preoperative chemotherapy with docetaxel, oxaliplatin and S-1 in gastric cancer with extensive lymph node metastasis (JCOG1704)

Future Oncol. 2020 Feb;16(4):31-38. doi: 10.2217/fon-2019-0528. Epub 2020 Jan 10.


Background: Although surgical resection is necessary to cure the locally advanced gastric cancer, it is sometimes difficult for extensive nodal metastasis such as para-aortic nodal disease or bulky nodal metastasis around the major gastric branched arteries. We had conducted several Phase II studies and clarified preoperative chemotherapy with doublet regimen followed by surgery markedly improved the survival for this disease. Recently, preoperative chemotherapy with docetaxel, oxaliplatin and S-1 (DOS) showed promising efficacy and acceptable feasibility for resectable advanced gastric cancer. Aim: To describe the design and rationale for the multi-institutional, single-arm, Phase II trial of systemic chemotherapy with DOS followed by surgery in advanced gastric cancer with extensive lymph node metastasis (JCOG1704). If efficacy and safety of DOS can be shown, we will conduct a Phase III trial comparing preoperative DOS and current standard cisplatin and S-1. Trial registration: jRCTs031180028.

Keywords: DOS; bulky lymph node metastasis; extensive lymph node metastasis; gastric cancer; para-aortic lymph node dissection; para-aortic lymph node metastases; preoperative chemotherapy.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study

MeSH terms

  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Chemotherapy, Adjuvant
  • Clinical Protocols*
  • Docetaxel / administration & dosage
  • Drug Combinations
  • Female
  • Humans
  • Lymphatic Metastasis
  • Male
  • Neoplasm Staging
  • Oxaliplatin / administration & dosage
  • Oxonic Acid / administration & dosage
  • Postoperative Care
  • Preoperative Care*
  • Stomach Neoplasms / drug therapy*
  • Stomach Neoplasms / mortality
  • Stomach Neoplasms / pathology*
  • Tegafur / administration & dosage


  • Drug Combinations
  • Oxaliplatin
  • S 1 (combination)
  • Tegafur
  • Docetaxel
  • Oxonic Acid