Gastric Cancer or Cancer at the Esophagogastric Junction
Conditions
Interventions
Patients are administrated bolus 5-FU/l-LV regimen chemotherapy consists of l-LV 250mg/m2/2h iv and 5-FU 600mg/m2 iv bolus given intravenously once weekly followed by 2-week rest period, within a 8-we
Sponsors
Hokkaido University Hospital Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. it was confirmed that it is histologically adenocarcinoma, unresectable gastric cancer or recurrent gastric cancer cases (not required histological confirmation in metastases) 2. Age: 20 years of age or older. Patient 3.ECOG PS of (Eastern Cooperative Oncology Group, Performance status) 0, 1 or 2, 4. S-1 or refractory to capecitabine against gastric cancer. However, after radical resection was enforced, if the S-1 or capecitabine was administered as adjuvant chemotherapy, it is determined that the refractory as long as it is a relapse within six months. 5. refractory or intorelance to chemotherapy, including platinum formulation (cisplatin or oxaliplatin). 6. refractory or intorelance to chemotherapy, including taxanes (paclitaxel or docetaxel). 7. refractory or intorelance to chemotherapy, including irinotecan. 8. refractory or intorelance to chemotherapy, including Ramucirumab. 9. Patients who wish to be given aggressive chemotherapy patient 10. major organs (bone marrow, heart, lung, kidney, etc.) feature of being held a. Neutrophil count is 1,200 / mm3 or more b. Platelet count is 75,000 / mm3 or more c. ALT is 3 times or less of the facility reference value upper limit. However five times or less the case with a liver metastasis. d. T-Bil is less than 2.0mg / dl e. Serum Cre is less than 2.0mg / dl 11. Patients can be expected to survive more than two months at the time 12. confirmed written informed consent
Exclusion criteria
Exclusion criteria: 1. patients with symptomatic central nerve metastasis 2. patients with uncontrolled active infection 3. patients with uncontrollable diarrhea 4. patients with uncontrollable ischemic heart disease 5. patients with ascites that requires frequent drainage 6. patients with intestinal obstruction condition requiring sustained drainage by long tube 7. patients with other serious complications not to be able to be given anti-cancer chemotherapy 8. Patients with other overlapping malignancies that can be a prognostic factor. 9. patients with difficulty to their decision-making with severe mental disorders to be estimated. 10. pregnant, or female patients with intention of lactating and pregnancy and childbirth. 11. Male patients who are willing to let the pregnancy. 12. patients using flucytosine. 13. Patients who have undergone bolus 5-FU containing anti-cancer chemotherapy in the past for their gastric cancer. 14.S-1 and capecitabine last administration day within seven days. 15. patient during radiation therapy. 16. Other, patients attending physician has determined unsuitable for the target of the study treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival rate at the time the treatment after 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| response rate, disease control rate, overall survival, progression free survival, time to treatment failure, adverse events, dose intensity and QOL by EORTC QLQ-C30 | — |
Countries
Japan
Contacts
Public ContactTetsuhito Muranaka
Hokkaido University Hospital cancer center
Outcome results
None listed