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A phase II study of preoperative chemotherapy cosisting docetaxel, oxaliplatin and S-1 for the clinical Stage III gastric cancer

A phase II study of preoperative chemotherapy cosisting docetaxel, oxaliplatin and S-1 for the clinical Stage III gastric cancer - A phase II study of preoperative DOS for cStage III gastric cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000017652
Enrollment
50
Registered
2015-05-22
Start date
2015-05-25
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

preoperative chemotherapy cosisting docetaxel, oxaliplatin and S-1

Sponsors

Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Histological proven adenocarcinoma. 2) cStage III gastric or esophagogastric junction cancer. 3) Not Borrmann type 4 and not large (8cm or less) type 3. 4) Possible for R0 surgery. 5) No prior treatment of chemotherapy or radiation therapy and no history of surgery for gastric cancer. 6) No active gastrointestinal bleeding. 7) Possible oral intake or administration of adequate calories using an enteral feeding tube. 8) ECOG performance status of 0 or 1. 9) Aged 20 to 79 years old. 10) No prior treatment of chemotherapy, radiation or hormone therapy against any other malignancies. 11) No history of gastrectomy other than endoscopic mucosal resection. 12) Adequate organ function. 13) Written informed consent from patient.

Exclusion criteria

Exclusion criteria: 1) Synchronous or metachronous (within 5 years) malignancies except for carcinoma in situ or mucosal tumors curatively treated with local therapy. 2) Past history of severe hypersensitivity to drugs. 3) Active infection. 4) Severe complications (interstitial pneumonia, pulmonary fibrosis, renal failure, liver failure, heart failure, uncontrollable diabetes millutus and Uncontrollable hypertension) 5) Peripheral motor neuropathy or peripheral sensory neuropathy by any reason. 6) Edema of limbs and trunk by any reason. 7) Continuous systemic steroid therapy. 8) Under treatment with flucytosine, phenytoin, or warfarin. 9) Abnormal electrocardiogram or severe cardiovascular disease. 10) Severe diarrhea. 11) Positive HBs antigen. 12) Pregnant women, or women with the possibility of the pregnancy and men who want let to pregnancy.

Design outcomes

Primary

MeasureTime frame
3-year progression-free survival

Secondary

MeasureTime frame
Overall survival, Progression-free survival, Response rate of preoperative chemotherapy, Pathological response rate, R0 resection rate, Proportion of adverse events.

Countries

Japan

Contacts

Public ContactYukinori Kurokawa

Osaka University Graduate School of Medicine Department of Gastroenterological Surgery

ykurokawa@gesurg.med.osaka-u.ac.jp06-6879-3251

Outcome results

None listed

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