The investigators hypothesis is that the combination of TS-ONE with cisplatin and trastuzumab is safe and as effective as combination treatment for HER2 positive gastric cancer.
Gastric carcinoma is the second most common cause of cancer death world-wide. Approximately 875,000 patients are diagnosed world-wide with gastric cancer each year. Gastric cancer is often diagnosed at an advanced stage1. At diagnosis, while some patients have gastric carcinoma that extends within loco-regional confines and can undergo a curative resection, many patients cannot undergo curative resection. Gastric cancer continues to pose a major medical challenge. While advanced gastric carcinoma is incurable, chemotherapy can have a palliative effect in symptomatic patients. Chemotherapy improves outcome compared to best supportive care in gastric cancer. Various chemotherapeutic agents including 5-FU, mitomycin, etoposide, cisplatin, irinotecan and the taxanes, have demonstrated activity as monotherapy. Combination chemotherapy has been shown to have better survival outcomes than single agent chemotherapy Standard chemotherapy for advanced gastric carcinoma includes a fluoropyrimidine and platinum -based combination chemotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Subjects will receive treatment that combined TS-ONE, cisplatin and trastuzumab every 3 weeks in this study. This 3 weeks period of time is called a cycle. The cycle will be repeated until subject experience disease progression or unbearable toxicities or they choose to withdraw from the study. Each cycle is numbered in order.
National University Hospital
Singapore, Singapore, Singapore
Overall Response Rate (ORR)
Time frame: Fom the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented
Progression free survival (PFS)
Time frame: Time from registration until objective tumor progression or death for any reason that occurs by the end of the study.
Overall survival (OS)
Time frame: Time from registration to the date of death.
Time to Treatment Failure (TTF)
Time frame: Time from registration until discontinuation of treatment for any reason (including progression of disease, treatment toxicity, and death).
Clinical Benefit Rate (CBR)
Time frame: proportion of patients with confirmed CR, PR, and SD over 24 weeks.
Duration of Response (DR)
Median time will be estimated using the Kaplan Meier method. 95% confidence interval of the median time will be estimated.
Time frame: Time from first assessment of CR or PR until the first date of PD or death within 60 days of the last tumor assessment or registration, whichever is first.
Safety Evaluations
AEs will be coded according to the Medical Dictionary for Regulatory Activities Terminology (MedDRA) and the severity of the toxicities will be graded according to the NCI CTCAE criteria, version 3.0, where applicable. Concomitant medications will be coded according to WHO Medication Dictionary for Concomitant Medication. All AEs will be summarized (incidence) and listed by the System Organ Class (SOC), preferred term, toxicity/severity grade, and causal relationship. In addition, separate summaries of SAEs and Grade 3 or 4 AEs will be presented. Cardiac AEs including asymptomatic LVEF drops will also be summarized in separate tables. Hematological and chemistry laboratory parameters will be graded according to the NCI CTCAE criteria, where applicable. Absolute values and changes from baseline will be summarized by cycle. In addition, worst severity grade will also be summarized.
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Time frame: Focus on AEs and laboratory assessments.