Gastric Cancer
Conditions
Interventions
capecitabine + cisplatin combination therapy
Sponsors
Epidemiological and Clinical Research Information Network (ECRIN)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Recurrent gastric cancer histologically confirmed as being adenocarcinoma 2)Between the ages of 20 and 74 years at the time informed consent is obtained 3)Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2 4)Lesions confirmed on imaging within 28 days before registration (not required measurable lesions) 5)Post-gastrectomy adjuvant chemotherapy including S-1 for at least 12 weeks including interruption period 6)Less than 6 months treatment free interval from completion of adjuvant therapy 7)Treatment-naive recurrent gastric cancer 8)Life expectancy of at least 3 months after registration 9)Personal written informed consent obtained after study fully explained 10)Major organ functions meet the criteria within 14 days before registration
Exclusion criteria
Exclusion criteria: 1)Positive HER2 status 2)Previous treatment with platinum agents 3)Previous history of serious hypersensitivity to fluoropyrimidines or platinum agents 4)Previous history of adverse reactions suggestive of dihydropyrimidine dehydrogenase (DPD) deficiency 5)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. 6)Obvious infection or inflammation 7)Active hepatitis 8)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 diarrhoea (watery stool or 4 times or more/day) 12)Active gastrointestinal haemorrhage 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS), Overall response rate (ORR), Time to treatment failure (TTF), Severity and incidence of adverse events | — |
Countries
Japan
Contacts
Public ContactYumi Miyashita
Epidemiological and Clinical Research Information Network (ECRIN) Aichi Devision
Outcome results
None listed