JPRN-UMIN000010949
Completed
Phase 2
Randomized phase II/III study of 5-fluorouracil /l-leucovorin vs. 5-fluorouracil /l-leucovorin plus paclitaxel in gastric cancer with severe peritoneal metastasis (JCOG1108/WJOG7312G, abbreviation:GC_FL/FLTAX_P2/3) - Phase II/III study of 5-FU/l-LV vs. 5-FU/l-LV+PTX in gastric cancer with severe peritoneal metastasis (FL/FLTAX trial)
Japan Clinical Oncology Group (JCOG)0 sites330 target enrollmentJune 13, 2013
ConditionsGastric cancer
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Gastric cancer
- Sponsor
- Japan Clinical Oncology Group (JCOG)
- Enrollment
- 330
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
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
Outcomes
Primary Outcomes
Not specified
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