JPRN-jRCTs051180186
Active, not recruiting
Phase 2
A phase II study of perioperative capecitabine plus Oxaliplatin(CapeOx) therapy for advanced gastric cancer with multiple lymph node metastases - OGSG 1701
SUGIMOTO Naotoshi0 sites30 target enrollmentMarch 26, 2019
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- advanced gastric cancer with lymph node metastases cannot be resected curatively, or poor prognosis.
- Sponsor
- SUGIMOTO Naotoshi
- Enrollment
- 30
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion 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
Exclusion 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
Outcomes
Primary Outcomes
Not specified
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