A feasibility study of neoadjuvant chemotherapy with docetaxel+cisplatin+capecitabine (DCX) for HER2-negative gastric cancer with macroscopic type 4 and large type 3, or with multiple lymph node metastasis

A feasibility study of neoadjuvant chemotherapy with docetaxel+cisplatin+capecitabine (DCX) for HER2-negative gastric cancer with macroscopic type 4 and large type 3, or with multiple lymph node metastasis - A feasibility study of neoadjuvant chemotherapy with docetaxel+cisplatin+capecitabine (DCX) for HER2-negative gastric cancer with macroscopic type 4 and large type 3, or with multiple lymph node metastasis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000026783

Enrollment

Registered

2017-05-01

Start date

2017-06-15

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric cancer

Interventions

Capecitabine 2000mg/m2/day days 1-14 Cisplatin 60mg/m2 day1 Docetaxel 30mg/m2 day1 every 3 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Gastric adenocarcinoma. HER2 IHC- or IHC1+, or IHC2+/FISH- 2) At least either of the following: 1. large type 3 (>=8cm) 2. type 4 3. Bulky N (at least one node of 3 cm or more in diameter, or at least three consecutive nodes each of diameter 1.5 cm or more, along the coeliac, splenic, common or proper hepatic arteries or superior mesenteric vein.) 3) ECOG PS 0-1 4) No previous chemothrapy or radiation therapy 5) Laboratory data 1.WBC>=3,000/mimcrol 2.Neutrophil>=1,500/microl 3.Hemoglobin>=8.0 g/dL 4.Platelet>=100,000/microl 5.Total bilirubin<=1.5 mg/dL 6.AST(GOT)<=ULNx2.5(<=ULNx5 if presence of liver metastasis) 7.ALT(GPT)<=ULNx2.5(<=ULNx5 if presence of liver metastasis) 8.Serum creatinine<=1.3 mg/dL 9.Creatinine clearance>=60 mL/min 10.Ejection fraction on echo cardiogram>=50%

Exclusion criteria

Exclusion criteria: 1) HER2 IHC 3+, or IHC 2 and FISH+ 2) Uncontrolled diabetes 3) Uncontrolled hypertension 4) Unstable angina pectoris, or a history of myocardial infarction within six months 5) Chronic lung disease: interstitial pneumonia, pulmonary fibrosis, or severe emphysema 6) Synchronous cancers (except for cases whose prognositc facter is gastric cancer) 7) Systemic infection requiring treatment 8) Fever above 38 degree Celsius 9) A possibility of pregnancy or during pregnancy, or lactating women 10) Psychosis or psychotic symptoms 11) Continuous systemic administration of steroids (oral or intravenous)

Design outcomes

Primary

Measure	Time frame
Adverse events	—

Secondary

Measure	Time frame
Overall survival Progression-free survival Proportion of patients with gastrectomy Proportion of patients with R0 resection Pahological response rate	—

Countries

Japan

Contacts

Public ContactOsamu Maeda

Nagoya University Hospital Department of Clinical Oncology and Chemotherapy

maeda-o@med.nagoya-u.ac.jp052-741-2111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026