Clinical trial · Interventional
Biweekly FOLFIRI in Advanced Gastric Cancer (AGC) With Failure of Prior Taxane, Fluoropyrimidine, and Cisplatin
A Phase II Study of Biweekly Oxaliplatin and 5-Fluorouracil/Leucovorin Combination Chemotherapy (FOLFIRI) in Patients With Advanced Gastric Cancer (AGC) With Failure of Prior Chemotherapy Including Taxane, Fluoropyrimidine and Cisplatinum
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is: * To observe the feasibility of biweekly oxaliplatin and infusional 5-fluorouracil (FU)/Leucovorin (LV) in patients with advanced gastric adenocarcinoma who have prior exposure to taxane, fluoropyrimidine, and cisplatin * To determine the activity of this combination regimen. * To evaluate the treatment-related toxicities.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| oxaliplatin, 5-fluorouracil | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- FOLFIRI arm
- description
- Patients receiving FOLFIRI
- interventionNames
- Drug: oxaliplatin, 5-fluorouracil
Primary outcomes (1)
- measure
- Progression-free survival
- timeFrame
- 4 months
Secondary outcomes (3)
- measure
- Overall survival
- timeFrame
- 1 year
- measure
- Toxicity profile (according to National Cancer Institute Common Terminology Criteria for Adverse Event [NCI CTC AE] version 3.0)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically proven non-resectable adenocarcinoma of stomach * Measurable disease based on Response Criteria in Solid Tumors (RECIST) * Prior chemotherapy with taxane, fluoropyrimidine, and cisplatinum in combination or sequentially, there is no time limit for the last chemotherapy * Age 18 to 70 years old * Estimated life expectancy of more than 3 months * Eastern Cooperative Oncology Group (ECOG) performance status of 2 or lower * Adequate bone marrow function (white blood cell counts \>4,000/µL, absolute neutrophil count \[ANC\]\>1,500/µL, hemoglobin \>9.0 g/dL, and platelets\>100,000/µL), * Adequate kidney function (creatinine\<1.5 mg/dL) * Adequate liver function (bilirubin\<1.5 mg/dL , transaminases levels\<3 times the upper normal limit \[5 times for patients with liver metastasis\], and serum albumin of \>2.5 mg/dL) Exclusion Criteria: * Other tumor type than adenocarcinoma * Presence or history of central nervous system metastasis * Obvious or impending bowel obstruction (including obvious peritoneal carcinomatosis) * Evidence of active gastrointestinal bleeding * Other serious illness or medical conditions
References
Publications (0)
Data not yet available