A phase II study of perioperative capecitabine plus Oxaliplatin(CapeOx) therapy for advanced gastric cancer with multiple lymph node metastases (OGSG 1701)

Phase 2

• Conditions: Gastric Cancer

• Registration Number: JPRN-UMIN000028749
• Lead Sponsor: Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-09-01
• Last Update Posted: 17 October 2023
• Study Completion: 2025-06-12

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

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 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response Rate(RR)(RECISTv1.0)

Secondary Outcome Measures

Name	Time	Method
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)