XParTS: Capecitabine/Cisplatin(XP) for Recurrent Gastric Cancer

Study Overview
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Brief Summary
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The aim of this study is to evaluate efficacy and safety of Capecitabine/Cisplatin for gastric cancer patients who relapsed after adjuvant chemotherapy by S-1.

Detailed Description
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S-1/Cisplatin (SP) is one of the standard treatments of advanced gastric cancer. However, evidence of SP on gastric cancer recurrence after adjuvant therapy by the same drug (S-1) is not established. The aim of this study is to evaluate the efficacy and safety of Capecitabine/Cisplatin (XP) for gastric cancer patients who relapsed after adjuvant chemotherapy by S-1.

Official Title
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Phase II Study to Evaluate Efficacy and Safety of Capecitabine/Cisplatin Combination Therapy in Gastric Cancer Patients Who Relapsed After S-1 Adjuvant Chemotherapy (XParTS)

Conditions
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Gastric Cancer

Intervention / Treatment
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* Drug: Capecitabine, Cisplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Recurrent gastric cancer histologically confirmed as being adenocarcinoma Age of 20 to 74 years with either gender ECOG Performance Status of 0 to 2 Lesions confirmed on imaging within 28 days before registration (not required measurable lesions as defined in RECIST version 1.1) Post-gastrectomy adjuvant chemotherapy including S-1 for at least 12 weeks including interruption period Less than 6 months treatment-free interval from completion of adjuvant therapy In case with receiving neoadjuvant chemotherapy, the total dose of CDDP does not exceed 120mg/m2 Treatment-naïve recurrent gastric cancer Life expectancy of at least 3 months after registration Written informed consent Adequate major organ functions within 14 days before registration Exclusion Criteria: Positive HER2 status Previous treatment with platinum agents after curative surgery 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 9) Concurrent illness 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) 10) Being treated or in need of treatment with phenytoin or warfarin potassium 11) Chronic diarrhea (watery stool or ≥ 4 times/day) 12) Active gastrointestinal hemorrhage 13) Body cavity fluids requiring drainage or other treatment 14) Clinical suspicion or previous history of metastases to brain or meninges 15) Women who are pregnant, breastfeeding, or potentially (hoping to become) pregnant 16) Unwillingness to practice contraception 17) Poor oral intake 18) Psychiatric disorders which are being or may need to be treated with psychotropics 19) 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 Weeks
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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Capecitabine, Cisplatin<br> | Drug: Capecitabine, Cisplatin<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 |  | 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 2 year | 
| Response rate |  | 2 year | 
| Time to treatment failure |  | 2 year | 
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability |  | 2 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastric cancer, recurrent gastric cancer, adenocarcinoma of the stomach, capecitabine, xp