Clinical trial · Interventional
Metronomic Chemotherapy in Advanced Gastric Cancer
Phase II Study of Metronomic Chemotherapy Using POLF Regimen in the Treatment of Advanced Gastric Cancer
NCT02855788CI-TRIAL-00023357unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
phase II study of weekly metronomic chemotherapy using weekly Paclitaxel, Oxaliplatin, Leucovorin and 5-FU (POLF) in patients with advanced gastric cancer
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Metastatic Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Paclitaxel 60mg/m2, Oxaliplatin 50mg/m2, Leucovorin 20mg/m2, and 5-FU 425mg/m2 IV weekly | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- POLF regimen
- description
- Paclitaxel 60mg/m2, Oxaliplatin 50mg/m2, Leucovorin 20mg/m2, and 5-FU 425mg/m2 IV weekly
- interventionNames
- Drug: Paclitaxel 60mg/m2, Oxaliplatin 50mg/m2, Leucovorin 20mg/m2, and 5-FU 425mg/m2 IV weekly
Primary outcomes (1)
- measure
- response rate
- timeFrame
- 3 months
- description
- based on Recist 1.1
Secondary outcomes (3)
- measure
- adverse events
- timeFrame
- 2 years
- description
- based on NCI-CTC v.2
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. pathologically confirmed gastric cancer AJCC stage III or IV 2. measurable disease based on CT or endoscopy exam 3. non-surgical candidates or patients who declined surgery 4. non-radiation candidates or patients who declined radiation 5. patients who are able to sign informed consent 6. patients who are 2 weeks out and recovered from surgery 7. patients who have completed radiation to relieve obstructive symptoms 8. patient who previously received Oxaliplatin and 5-FU in other MTD regimens 9. adequate marrow function: neutrophil \>1000/ul, Hgb \>10g/dl, Plt\>50,000 Exclusion Criteria: 1. allergic to any of the drugs involved 2. concurrent malignancies 3. severe co-morbidities of heart, lungs, kidneys and bone marrow 4. severe psychological disorder 5. severe malnutrition 6. difficult to heal or unhealed wound 7. ECOG performance status equal or over 3 8. uncontrolled complications from the malignancy 9. uncontrolled CNS metastasis 10. peripheral neuropathy grade 3 or above 11. pregnancy or breast feeding
References
Publications (0)
Data not yet available
No reference posted for this study.