HIGHSOX study

JRCT ID: jRCTs051180196

Registered date:26/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: HER2 positive unresectable advanced gastric cancer
• Date of first enrollment: 24/06/2015
• Target sample size: 75
• Study type: Interventional
• Intervention(s): HIGHSOX: S-1; 80 mg/day, 100 mg/day, 120 mg/day [day1-day15], Oxaliplatin; 130mg/m2 [day1], Trastuzumab; first: 8mg/kg(body), After the second time: 6mg/kg(body) [day1]: The treatment will be repeated every 3 weeks, untill the disease progression, unacceptable toxicity, tumor resection, or consent withdrawel.

Outcome(s)

• Primary Outcome: Response Rate

Secondary Outcome

Progression free survival,
Overall survival,
Safety

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Takahari Daisuke
• Source(s) of Monetary Support: Cancer collective research foundation
• Secondary ID(s): UMIN000017602