Clinical trial · Interventional
FOLFOX6 Versus mFOLFIRINOX as First Line Chemotherapy in Metastatic Gastric Cancer or Esophagogastric Junction Adenocarcinoma (Type II-III)
FOLFOX6 Versus mFOLFIRINOX as First Line Chemotherapy in Metastatic Gastric or Esophagogastric Junction Adenocarcinoma (Type II-III): Open-label Randomized Phase 2/3 Trial
- 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)
Patients with metastatic adenocarcinoma of the stomach or the esophagogastric junction (II-III type by Siewert) without previous therapy will be treated with one of two chemotherapy combinations . One half of the patients gets 5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin (FOLFOX6), the others 5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin and Irinotecan (mFOLFIRINOX). Main objective of the study is progression free survival.
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 |
|---|---|---|---|
| Esophagogastric Junction Adenocarcinoma Stage IV | Gastroesophageal Junction Adenocarcinoma | CURATED_BROADER | 0.78 |
| Gastric Carcinoma Stage IV | Gastric Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-FU | Drug | Fluorouracil | ALIAS |
| Irinotecan | Drug | Irinotecan | ALIAS |
| Leucovorin | Drug | Leucovorin | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- FOLFOX6
- description
- 5FU 400mg/m2 iv bolus d1, 5-FU 2400 mg/m² d1-2, Leucovorin 400 mg d1, Oxaliplatin 85 mg/m² d1, every two weeks (q2w) 9 cycles
- interventionNames
- Drug: Oxaliplatin
- Drug: Leucovorin
- Drug: 5-FU
- type
- EXPERIMENTAL
- label
- mFOLFIRINOX
- description
- Irinotecan 180mg/m2 d1, 5FU 250mg/m2 iv bolus d1, 5-FU 2200 mg/m² d1-2, Leucovorin 400 mg d1, Oxaliplatin 85 mg/m² d1, every two weeks (q2w) 9 cycles
- interventionNames
- Drug: Irinotecan
- Drug: Oxaliplatin
- Drug: 5-FU
- Drug: Leucovorin
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. histologically confirmed locally advanced, recurrent or metastatic adenocarcinoma of the esophagogastric junction (Siewert type II-III) or the stomach 2. no prior palliative chemotherapy or radiation therapy 3. Age 18-70 years (female and male) 4. Eastern Cooperative Oncology Group ≤ 2 5. Neutrophils\> 2.000/µl 6. Platelets \> 100.000/µl 7. Normal value of Serum Creatinin 8. Albumin level \> 29 г/л 9. Aspartate transaminase (AST) or alanine transaminase (ALT) less than 3 times the upper limits of normal (ULN) 10. Total Bilirubin less than 1.5 times the ULN 11. Written informed consent. Exclusion Criteria: 1. Previous palliative cytostatic chemotherapy 2. Cancer relapse 3. Complicated gastric cancer (perforation, bleeding, sub or decompensated stenosis, dysphagia IV) 4. Diarrhea ≥ 2 according to the criteria of Common Terminology Criteria for Adverse Events (CTCAE) version 4.1; 5. Hypersensitivity against 5- Fluorouracil, Leucovorin, Oxaliplatin, irinotecan 6. Existence of contraindications against 5- Fluorouracil, Leucovorin, Oxaliplatin, Irinotecan or Docetaxel 7. Active coronary heart disease, Cardiomyopathy or cardiac insufficiency stage III-IV according to New York Heart Association (NYHA) 8. Severe non-surgical accompanying disease or acute infection (uncontrolled arterial hypertension, diabetes mellitus, stroke less than 6 months old, mental disorders, other tumors and others) 9. Malignant secondary disease, dated back \< 5 years (exception: In-situ-carcinoma of the cervix uteri, adequately treated skin basal cell carcinoma) 10. Peripheral polyneuropathy \> Grad II 11. Liver dysfunction (AST)/ALT\>3,0xULN, ALT\>3xULN, Bilirubin\>1,5xULN) Serum Creatinin \>1,0xULN 12. Chronic inflammable gastro-intestinal disease 13. Inclusion in another clinical trial 14. Pregnancy or lactation 15. Hepatitis B or C in the active stage 16. Human immunodeficiency virus(HIV) infected 17. Serious concomitant somatic and mental illnesses / deviations or territorial causes that may prevent the patient from participating in the protocol and observing the protocol schedule 18. Foreigners or persons with limited legal status
References
Publications (0)
Data not yet available