FOLFOX6 Versus mFOLFIRINOX as First Line Chemotherapy in Metastatic Gastric Cancer or Esophagogastric Junction Adenocarcinoma (Type II-III) (IRIGA)

Blokhin's Russian Cancer Research Center

Status and phase: Enrolling; Phase 2

Conditions: Gastric Carcinoma Stage IV; Esophagogastric Junction Adenocarcinoma Stage IV

Treatments: Drug: Irinotecan; Drug: 5-FU; Drug: Leucovorin; Drug: Oxaliplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT04442984

2020-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 326 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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326 participants in 2 patient groups

FOLFOX6

Active Comparator group

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

Treatment:

Drug: Leucovorin

Drug: 5-FU

Drug: 5-FU

Drug: 5-FU

Drug: Oxaliplatin

Drug: 5-FU

mFOLFIRINOX

Experimental group

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

Treatment:

Drug: Leucovorin

Drug: Irinotecan

Drug: 5-FU

Drug: 5-FU

Drug: 5-FU

Drug: Oxaliplatin

Drug: 5-FU