FOLFIRINOX vs FLOT Chemotherapy for Resectable Gastric or Esophagogastric Junction Adenocarcinoma (NCT04393584) | Clinical Trial Compass
UnknownPhase 2/3
FOLFIRINOX vs FLOT Chemotherapy for Resectable Gastric or Esophagogastric Junction Adenocarcinoma
Russia538 participantsStarted 2019-01-29
Plain-language summary
Patients with resectable 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 before and after surgery. One half of the patients gets 5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin and Docetaxel (FLOT), the others 5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin and Irinotecan (FOLFIRINOX). Main objective of the study is median overall survival.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. сT4 cN0 or cT1-4 cN+ histologically proven adenocarcinoma of the esophagogastric junction (Siewert type II-III) or the stomach without distant metastases (M0)
✓. No previous cytostatic chemotherapy or radiation therapy
✓. Age 18-70 years (female and male)
✓. Eastern Cooperative Oncology Group ≤ 2
✓. Surgical resectability
✓. Neutrophils\> 2.000/µl
✓. Platelets \> 100.000/µl
✓. Normal value of Serum Creatinin
Exclusion criteria
✕. Previous cytostatic chemotherapy or radiation therapy
✕. Distant metastases or all primarily not resectable stages
✕. Cancer relapse
✕. Complicated gastric cancer (perforation, bleeding, sub or decompensated stenosis, dysphagia IV)
✕. Diarrhea ≥ 2 according to the criteria of Common Terminology Criteria for Adverse Events (CTCAE) version 4.1;
✕. Hypersensitivity against 5- Fluorouracil, Leucovorin, Oxaliplatin, Epirubicin and Docetaxel