OGSG 1701

JRCT ID: jRCTs051180186

Registered date:26/03/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: advanced gastric cancer with lymph node metastases cannot be resected curatively, or poor prognosis.
• Date of first enrollment: 02/02/2018
• Target sample size: 30
• Study type: Interventional

Intervention(s)

preoperative CapeOx therapy
Capecitabine : 1,000mg/m2 bid, day1-14, q3w
Oxaliplatin : 130mg/m2, day 1, q3w
3 cycle
Surgery
Postoperative CapeOx therapy
Capecitabine : 1,000mg/m2 bid, day1-14, q3w
Oxaliplatin : 130mg/m2, day 1, q3w
5 cycle

Outcome(s)

• Primary Outcome: Response Rate(RR)(RECISTv1.0)

Secondary Outcome

1.Overall survival(OS)
2.Progression free survival
3.Rate of curative resection
4.Complete rate of protocol
5.Complete rate of preoperative chemotherapy
6.Complete rate of operation
7.Complete rate of postoperative chemotherapy
8.Relative Dose Intensity (RDI)
9.Response Rate of Histologically
10.Incidence of adverse events on perioperative chemotherapy
11.Incidence of a intraoperative and postoperative complication
12.Response Rate (RR)(RECISTv1.1)

Key inclusion & exclusion criteria

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

Include criteria

1)Histologically proven gastric carcinoma by endoscopic detection
2)HER2 negative or unknown
3)With any lesion written below by upper abdominal enhanced CT:
1.Paraaortic node metastases (#16a2/16b1) larger than 10mm
2.Bulky lymph node metastases located at celiac axis, common hepatic artery, splenic artery and/or upper mesenteric vein which make a huge bulk larger than 3.0 cm and/or multiple
large bulks larger than 1.5 cm
3.Paraaortic and bulky metastatic nodes
4)Without any lesions written below by thoratic, upper abdominal and pelvic enhanced CT:
1.mediastinal node metastases
2.lung metastases
3.peritoneal metastases
4.liver metastases
5.pleural fluid and/or ascites
6.paraaortic nodes metastases (# 16a1 and/or #16b2)
7.Other distant nodes metastases and/or CY1
5) Not a large type 3 or type 4 gastric cancer
Large: the size of cancer is larger than 8 cm
6)Without esophageal invasion longer than 3 cm
7)Not a remnant gastric cancer
8)Without cervical nodes metastases and/or distant metastases
9)Age between 20 and 80 years old
10)An Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
11) Without any prior chemotherapy, radiation therapy and/or hormone therapy for the gastric cancer and/or any other cancers
12)Without prior surgical therapy except EMR/ESD and/or bypass
13) Patients can take food orally with /without bypass
14) With good functions of important organs by a data taken within 2 weeks
of registration
1.Neutrophil: =>1,500/mm3
2.Hemoglobin: =>8.0 g/dL without blood transfusion
3.Platelet: =>100,000/mm3
4.AST, ALT: =< 100 IU/L
5.T.bil.: =<2.0 mg/dL
6.Creatinine clearance: =>60 ml/min/body
CC by Cockcroft-Gault method is available:=>60mL/min
15) With written Informed Consent

Exclude criteria

1)With active double cancers excluding carcinoma in situ and/or prior cancer cured with longer than 5 year interval period
2)Pregnant or nursing female
3)Male expecting pregnancy of partner
4)Impossible to register to the study due to a psychological disorder by physician in charge's decision
5)Under continuous steroids medication
6)Patients who receives systemic continuous administration of phenytoin or warfarin potassium
7)With neuropathy on peripheral motor and/or sensory nerves: -> glade 2 of CTCAE v4.0
8)With interstitial pneumonitis, pulmonary fibrosis and/or severe pulmonary emphysema
9)With active bacterial/fungal infectious disease (with a fever over 38 centigrade)
10)With a history of cardiac infarction and/or anxiety angina pectoris within 6 months
11)With uncontrollable blood hypertension
12)With uncontrollable DM
13)With uncontrollable Diarrhea
14)Positive HBs antigen
15)Severe complications
16)Any other patients whom the physician in charge of the study judges to be unsuitable

Related Information

• Primary Sponsor: SUGIMOTO Naotoshi
• Source(s) of Monetary Support: Yakult Honsha Co.,Ltd.
• Secondary ID(s): UMIN000028749