HIGHSOX study
- Conditions
- HER2 positive unresectable advanced gastric cancer
- Registration Number
- JPRN-jRCTs051180196
- Lead Sponsor
- Takahari Daisuke
- Brief Summary
Results from this phase 2 study suggest that trastuzumab with SOX is well tolerated and has promising efficacy, offering one possibility of new treatment option as a first-line chemo therapy for patients with HER2-positive advanced gastric cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 75
1) Histologically proven advanced or recurrent adenocarcinoma
2) No prior therapy except for adjuvant chemotherapy of S-1 finished more than 6 months before
3) With measurable lesions by RECIST version 1.1
4) HER2 positive (IHC 3+ or IHC 2 + and ISH +)
5) Age 20 - 75
6) ECOG PS 0 or 1
7) No symptomatic cerebral lesions
8) Adequate organ functions
9) LVEF (Left Ventricular Ejection Fraction) > 50 %
10) No abnormal findings in ECG
11) Possible for oral intake
12) With an expected survival longer than 3 months
13) Wth written Informed consent
1) Could not administrate S-1, oxaliplatin, and trastuzumab
2) Pregnant and/or nursing women or men who wish to have children in future
3) With active infectious disease
4) HBs antigen positive
5) With a history or current symptoms of heart failure, uncontrollable arrhythmia, angina pectoris, valvular disease, and uncontrollable hypertension
6) With interstitial pneumonia, pulmonary fibrosis, heart failure, renal failure, hepatic failure, uncontrollable diabetes mellitus
7) With dyspnea at rest
8) With active bleeding from gastric cancer / ulcer
9) With severe diarrhea
10) With severe sensory neuropathy
11) With active double cancers excluding carcinoma in situ and/or prior curative cancer with relapse free for more than 5 years
12) Under meditation of flucytosine, phenytoin,or warfarin
13) Under continuous meditation of steroids
14) Judged to be unfit to participate in this study by investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response Rate
- Secondary Outcome Measures
Name Time Method Progression free survival, <br>Overall survival, <br>Safety