jRCTs051180196CompletedNot Applicable
A phase II study of Trastuzumab with S-1 plus Oxaliplatin for HER2 positive advanced gastric cancer (Herceptin with SOX for Gastric Cancer) (HIGHSOX study)
Not provided0 sites75 target enrollmentStarted: June 24, 2015Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 75
- Primary Endpoint
- -
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Single Arm Study
- Intervention Model
- Single Assignment
- Primary Purpose
- Treatment Purpose
- Masking
- Open(masking Not Used)
Eligibility Criteria
- Ages
- 20age old over to 75age old under (—)
- Sex
- All
Inclusion Criteria
- •Histologically proven advanced or recurrent adenocarcinoma
- •No prior therapy except for adjuvant chemotherapy of S-1 finished more than 6 months before
- •With measurable lesions by RECIST version 1.1
- •HER2 positive (IHC 3+ or IHC 2 + and ISH +)
- •Age 20 - 75
- •ECOG PS 0 or 1
- •No symptomatic cerebral lesions
- •Adequate organ functions
- •LVEF (Left Ventricular Ejection Fraction) > 50 %
- •No abnormal findings in ECG
- •Possible for oral intake
- •With an expected survival longer than 3 months
- •Wth written Informed consent
Exclusion Criteria
- •Could not administrate S-1, oxaliplatin, and trastuzumab
- •Pregnant and/or nursing women or men who wish to have children in future
- •With active infectious disease
- •HBs antigen positive
- •With a history or current symptoms of heart failure, uncontrollable arrhythmia, angina pectoris, valvular disease, and uncontrollable hypertension
- •With interstitial pneumonia, pulmonary fibrosis, heart failure, renal failure, hepatic failure, uncontrollable diabetes mellitus
- •With dyspnea at rest
- •With active bleeding from gastric cancer / ulcer
- •With severe diarrhea
- •With severe sensory neuropathy
- •With active double cancers excluding carcinoma in situ and/or prior curative cancer with relapse free for more than 5 years
- •Under meditation of flucytosine, phenytoin,or warfarin
- •Under continuous meditation of steroids
- •Judged to be unfit to participate in this study by investigator
Outcomes
Primary Outcomes
-
Response Rate
Secondary Outcomes
No secondary outcomes reported
Investigators
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