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)
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)
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.
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.
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