Clinical trial · Interventional
FOLFOX Followed by FOLFIRI or Reverse Sequence Treatment in Advanced Gastric Cancer (AGC)
Randomized Phase II Study of FOLFOX Followed by FOLFIRI or Reverse Sequence Treatment in Patients With Advanced or Relapsed Gastric Cancer
- 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)
FOLFOX\* followed by FOLFIRI\*\* or reverse sequence treatment regimen have been used as a standard treatment modality in metastatic colorectal cancer.Oxaliplatin and Irinotecan were used for advanced gastric cancer also. The investigators study was designed to evaluate the safety and efficacy of FOLFOX followed by FOLFIRI or reverse sequence treatment regimen as a first-line and second line therapy for patients with relapsed or metastatic gastric cancer similar with colorectal cancer. \*FOLFOX: oxaliplatin followed by leucovorin before bolus 5-FU followed by continuous infusion 5-FU \*\*FOLFIRI: irinotecan followed by leucovorin before bolus 5-FU followed by continuous infusion 5-FU
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 |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| irinotecan, oxaliplatin | Drug | — | UNRESOLVED |
| oxaliplatin, irinotecan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- IROX arm: FOLFIRI -> FOLFOX
- description
- IROX arm: FOLFIRI -\> FOLFOX FOLFOX REGIMEN D1 Oxaliplatin 85mg/m2 + 5DW 500ml MIV over 120min D1,D2 Leucovorin 50mg IV Push D1,D2 5-Fluorouracil 400mg/m2 IV Push D1,D2 5-Fluorouracil 600mg/m2 + 5DW 1000ml MIV over 22hr Every 2 weeks FOLFILI REGIMEN D1 Irinotecan 150mg/m2 + 5DW 500ml MIV over 120min D1,D2 Leucovorin 50mg IV Push D1,D2 5-Fluorouracil 400mg/m2 IV Push D1,D2 5-Fluorouracil 600mg/m2 + 5DW 1000ml MIV over 22hr
- interventionNames
- Drug: irinotecan, oxaliplatin
- type
- ACTIVE_COMPARATOR
- label
- OXIR arm: FOLFIRI -> FOLFOX
- description
- OXIR arm: FOLFIRI -\> FOLFOX FOLFOX REGIMEN D1 Oxaliplatin 85mg/m2 + 5DW 500ml MIV over 120min D1,D2 Leucovorin 50mg IV Push D1,D2 5-Fluorouracil 400mg/m2 IV Push D1,D2 5-Fluorouracil 600mg/m2 + 5DW 1000ml MIV over 22hr Every 2 weeks FOLFILI REGIMEN D1 Irinotecan 150mg/m2 + 5DW 500ml MIV over 120min D1,D2 Leucovorin 50mg IV Push D1,D2 5-Fluorouracil 400mg/m2 IV Push D1,D2 5-Fluorouracil 600mg/m2 + 5DW 1000ml MIV over 22hr
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed gastric cancer * No prior chemotherapy for palliative setting * ECOG PS \<3 * Measurable lesion on CT * adequate kidney function (CCr ≥ 40 ml/min) * adequate liver function (Transaminase \< 3 X upper normal value, Bilirubin \< 2 mg%) * adequate BM function (ANC \> 1500/ul, platelet \> 75000/ul) * informed consent Exclusion Criteria: * other cancer history * pregnant or breast feeding * inadequate general condition for chemotherapy * allergy to oxaliplatin or irinotecan
References
Publications (0)
Data not yet available