Trials / Unknown
UnknownNCT04442984
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
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 326 (estimated)
- Sponsor
- Blokhin's Russian Cancer Research Center · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Irinotecan | d1 Irinotecan 180mg/m² every two weeks |
| DRUG | Oxaliplatin | d1 Oxaliplatin 85 mg/m² every two weeks |
| DRUG | 5-FU | d1-2 5-FU 2200 mg/m² every two weeks |
| DRUG | 5-FU | d1 5-FU 250 mg/m² every two weeks |
| DRUG | Leucovorin | d1 Leucovorin 400 mg every two weeks |
| DRUG | 5-FU | d1 5-FU 400 mg/m² every two weeks |
| DRUG | 5-FU | d1-2 5-FU 2400 mg/m² every two weeks |
Timeline
- Start date
- 2019-11-03
- Primary completion
- 2021-11-03
- Completion
- 2024-11-03
- First posted
- 2020-06-23
- Last updated
- 2021-04-13
Locations
1 site across 1 country: Russia
Source: ClinicalTrials.gov record NCT04442984. Inclusion in this directory is not an endorsement.