FOLFOX6 Versus mFOLFIRINOX as First Line Chemotherapy in Metastatic Gastric Cancer or Esophagogastric Junction Adenocarcinoma (Type II-III)
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- STATUS
- Recruiting
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- participants needed
- 326
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- sponsor
- Blokhin's Russian Cancer Research Center
Summary
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.
Description
This parallel, randomized, open-label study 326 patients with metastatic ( adenocarcinoma of the stomach or the esophagogastric junction without previous therapy will be included in this study. After randomization patients receive 9 cycles FOLFOX6 or mFOLFIRINOX.
Stratification factors include ECOG, site of metastasis, age, pathological subtypes.
Efficacy will be evaluated every 3 cycles with RECIST. Toxicity will be assessed with WHO CTC 3.0 every 2 weeks.
Details
| Condition | Gastric Carcinoma Stage IV, Esophagogastric Junction Adenocarcinoma Stage IV |
|---|---|
| Age | 18years - 75years |
| Treatment | Irinotecan, Oxaliplatin, 5-FU, Leucovorin |
| Clinical Study Identifier | NCT04442984 |
| Sponsor | Blokhin's Russian Cancer Research Center |
| Last Modified on | 19 February 2024 |
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