A phase II study of preoperative DOS for cStage III gastric cancer

JRCT ID: jRCTs051180086

Registered date:04/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Gastric cancer
• Date of first enrollment: 14/06/2015
• Target sample size: 50
• Study type: Interventional
• Intervention(s): preoperative chemotherapy consisting docetaxel, oxaliplatin and S-1

Outcome(s)

• Primary Outcome: progression-free survival
• Secondary Outcome: overall survival, response rate, pathological response rate, R-0 resection rate, adverse event rate

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 80age old
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Kurokawa Yukinori
• Source(s) of Monetary Support: Yakult Honsha
• Secondary ID(s): UMIN000017652