XParTS II: Capecitabine/CDDP(XP) and S-1/CDDP(SP) as the First-line Treatment for Advanced Gastric Cancer

Study Overview
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Brief Summary
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The aim of this study is to elucidate the efficacy and safety of XP and SP for first-line treatment of Advanced Gastric Cancer.

Detailed Description
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XP and SP are either standard treatment for advanced gastric cancer. The aim of this study is to elucidate the efficacy and safety of Capecitabine/Cisplatin and S-1/Cisplatin for first-line treatment of Advanced Gastric Cancer.

Official Title
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A Randomized Phase II Trial Comparing Capecitabine/CDDP(XP) and S-1/CDDP(SP) as the First-line Treatment for Advanced Gastric Cancer (XParTS II)

Conditions
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Gastric Cancer

Intervention / Treatment
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* Drug: SP
* Drug: XP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed gastric adenocarcinoma with unresectable metastatic or recurrent disease Lesions confirmed on imaging within 28 days before registration (not required measurable lesions as defined in RECIST version 1.1) No previous chemotherapy or radiotherapy. However, adjuvant chemotherapy is allowed the case of more than 6 months from the end of adjuvant chemotherapy ECOG Performance Status of 0 to 2 Life expectancy of at least 3 months after registration Written informed consent Age of 20 to 74 years with either gender Adequate Major organ functions within 14 days before registration Exclusion Criteria: Positive HER2 status Previous history of fluoropyrimidines therapy within 6 months prior to registration Previous treatment with platinum agents Previous history of serious hypersensitivity to fluoropyrimidines or platinum agents Previous history of adverse reactions suggestive of dihydropyrimidine dehydrogenase (DPD) deficiency More than one cancer at the same time or more than one cancer at different times separated by a 5-year disease-free interval. However, multiple active cancers do not include carcinoma in situ or skin cancer which is determined to have been cured as a result of treatment. Obvious infection or inflammation (pyrexia ≥ 38.0˚C) Active hepatitis Heart disease that is serious or requires hospitalization, or history of such disease within past year Having complication that is serious or requires hospitalization (intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, poorly controlled diabetes mellitus, renal failure, liver disorders, or hepatic cirrhosis) Being treated or in need of treatment with flucytosine, phenytoin or warfarin potassium Chronic diarrhea (watery stool or ≥4 times/day) Active gastrointestinal bleeding Body cavity fluids requiring drainage or other treatment Clinical suspicion or previous history of metastasis to brain or meninges Women who are pregnant, breastfeeding, or potentially (hoping to become) pregnant Unwillingness to practice contraception Poor oral intake Psychiatric disorders which are being or may need to be treated with psychotropics Otherwise determined by investigators or site principal investigators to be unsuitable for participation in study

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: S-1,Cisplatin<br> | Drug: SP<br>* Drug: S-1: S-1 will be administered at 40 mg/m2 orally, twice daily (80 mg/m2 total daily dose) on Days 1 through 21 of each 35-day treatment cycle. Drug: Cisplatin: Cisplatin will be administered at 60 mg/m2 by intravenous infusion on Day 8 of each 35-day treatment cycle.<br>|
| Experimental: Capecitabine, Cisplatin<br> | Drug: XP<br>* Drug: Capecitabine: Capecitabine will be administered at 1,000 mg/m2 orally, twice daily (2,000 mg/m2 total daily dose) on Days 1 through 14 of each 21-day treatment cycle. Drug: Cisplatin: Cisplatin will be administered at 80 mg/m2 by intravenous infusion on Day 1 of each 21-day treatment cycle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival rate |  | at 24weeks from patient enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time-to treatment failure |  | 3year | 
| Response rate |  | 3 year | 
| Overall survival |  | 3 year | 
| Safety |  | 3 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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unresectable gastric cancer, recurrent gastric cancer, StageIV gastric cancer, adenocarcinoma of the stomach, XP, SP