Gastric cancer
Conditions
Interventions
A: 5-FU/ l-LV 5-FU : 600 mg/m2/day, bolus (1 hour after start of l-LV) : day 1, 8, 15, 22, 29, 36 l-LV : 250 mg/m2/day, div (2 hours) : day 1, 8, 15, 22, 29, 36 q8w
B: FLTAX 5-FU : 500 mg/m2/d
Sponsors
Japan Clinical Oncology Group (JCOG)
West Japan Oncology Group (WJOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Unresectable or recurrent gastric cancer with peritoneal metastasis 2) histologically confirmed adenocarcinoma 3) Massive ascites and/or inadequate oral intake. In case of massive ascites and inadequate oral intake, patients with PS0 or PS1 are eligible. 4) No metastasis to central nervous system 5) No fistula between tumor and other organ 6) No pleural effusion needed to be removed 7) Measurable or non-measurable disease 8) Between the ages of 25 and 75 9) ECOG Performance status(PS): 0, 1, 2. In case of patients with PS2, massive ascites, and inadequate oral intake, they are ineligible. 10) HER2 untested or negative in case of tested 11) No previous chemotherapy or radiotherapy or chemoradiotherapy or hormone therapy for other malignancies (neoadjuvant or adjuvant chemotherapy for gastric cancer is allowed as long as it was completed at least 24 weeks prior to randomization) 12) Adequate organ function as evidenced by the following laboratory studies within 14 days prior to enrollment <1> Neutrophil count: 1,500/mm3 or above <2> Hemoglobin: 8.0 g/dL or above <3> Platelet count: 100,000/mm3 or above <4> Total bilirubin: 1.5 mg/dL or less <5> AST (GOT) :100 IU/L or less <6> ALT (GPT) :100 IU/L or less <7> Serum creatinin: 2.0 mg/dL or less 13) Written infromed consent
Exclusion criteria
Exclusion criteria: 1) Other currently active malignancies excluding malignancies that are disease free for more than 5 years or carcinoma-in -situ deemed cured by adequate treatment 2) Active infection 3) Body temperature >= 38 degrees Celsius 4) Pregnant of lactating female 5) Psychiatric disease that is inappropriate for entry into this study 6) Continuous systemic steroids 7) Uncontrolled diabetes despite routine administration of insullin 8) Myocardial infarction within the last 6 months, unstable angina pectoris within the last 3 weeks 9) History of any medical condition including renal insufficiency, liver insufficiency, and interstitial pneumonitis 10)Active bleeding 11) HBs Ag: positive, HCV Ab: positive
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase II: Median survival time in both arms and proportion of treatment continuation at 8th week in FLTAX arm Phase III: Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase II: Proportion of treatment continuation at 8th week in 5-FU/l-LV arm and adverse events in both arms Phase III: Adverse events, Proportion of oral intake improvement, Ascites drainage-free survival, Proportion of ascites response, Proportion of ascites control, QOL, Time-to-treatment failure, Dose intensity | — |
Countries
Japan
Contacts
Public ContactKensei Yamaguchi, Takako Nakajima
JCOG1108/WJOG7312G Coordinating Office The Cancer Institute Hospital Of JFCR / St.Marianna University School of Medicine
Outcome results
None listed