Clinical trial · Interventional
A Phase II Trial of Perioperative Chemotherapy With Oxaliplatin, 5-Fluorouracil, Leucovorin(MODIFIED FOLFOX6) in Patients With Locally Advanced Operable Gastric Cancer
NCT01851941CI-TRIAL-00010270completedPhase 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)
The role of perioperative chemotherapy in potentially operable advanced gastric cancer (AGC) with regional lymph node metastasis is still in the area of controversy. The aim of this study is to evaluate the efficacy and toxicity of folinic acid (FA), infusional 5-fluorouracil (5-FU), and oxaliplatin (modified FOLFOX6) in potentially resectable AGC with regional lymph node (LN) metastasis.
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 |
|---|---|---|---|
| mFOLFOX6 (folinic acid, 5-fluorouracil, and oxaliplatin ) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- mFOLFOX6
- description
- Modified FOLFOX6 regimen consists of oxaliplatin 100 mg/m2 and FA 100 mg/m2 given as a 2 hour intravenous infusion, followed by 5-FU 2.4 g/m2 given as a continuous infusion over 46 hour, which is repeated every 2 weeks. Patients receive 4 cycles of neoadjuvant modified FOLFOX6 followed by curative radical surgery with D2 dissection and 4 cycles of adjuvant modified FOLFOX6.
- interventionNames
- Drug: mFOLFOX6 (folinic acid, 5-fluorouracil, and oxaliplatin )
Primary outcomes (1)
- measure
- clinical response rate as assessed using RECIST criteria, with computed tomography (CT) scans at baseline and after 4cycles of chemotherapy
- timeFrame
- 4 cycles of chemotherapy (expected average of 8 weeks)
Secondary outcomes (2)
- measure
- Time to progression
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Previously untreated patients with pathologically proven advanced gastric adenocarcinoma with regional LN metastasis (clinical stage: cT2-4 and N+) * At least one measurable regional lymph node metastasis according to the Response Evaluation Criteria in Solid Tumors (RECIST v. 1.0) * age between 18 and 75 years * Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 * no prior chemotherapy or radiotherapy * adequate bone marrow, hepatic and renal function (absolute neutrophil count \[ANC\] ≥ 1.5ⅹ109/L, platelet count ≥ 100ⅹ109/L, total bilirubin ≤ 1.5ⅹupper limit of normal \[ULN\], serum transaminases ≤ 2.5ⅹULN, alkaline phosphatase ≤ 2.5ⅹULN, serum creatinine ≤ 1.5ⅹULN or actual or calculated creatinine clearance ≥ 50 mL/min). Exclusion Criteria: * clinical stage T1 tumors * clinical or radiologic evidence of distant metastasis * intestinal obstruction or impending obstruction * active tumor bleeding * interstitial pneumonitis or symptomatic pulmonary fibrosis * peripheral neuropathy of National Cancer Institute Common Toxicity Criteria (NCI-CTC) grade ≥1 * pregnant or breastfeeding patients * other serious diseases
References
Publications (0)
Data not yet available
No reference posted for this study.