FOLFOX6 Versus mFOLFIRINOX as First Line Chemotherapy in Metastatic Gastric Cancer or Esophagogastric Junction Adenocarcinoma (Type II-III)
NCT ID: NCT04442984
Last Updated: 2021-04-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
326 participants
INTERVENTIONAL
2019-11-03
2024-11-03
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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FOLFOX6
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
Oxaliplatin
d1 Oxaliplatin 85 mg/m² every two weeks
Leucovorin
d1 Leucovorin 400 mg every two weeks
5-FU
d1 5-FU 400 mg/m² every two weeks
5-FU
d1-2 5-FU 2400 mg/m² every two weeks
mFOLFIRINOX
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
Irinotecan
d1 Irinotecan 180mg/m² every two weeks
Oxaliplatin
d1 Oxaliplatin 85 mg/m² every two weeks
5-FU
d1-2 5-FU 2200 mg/m² every two weeks
5-FU
d1 5-FU 250 mg/m² every two weeks
Leucovorin
d1 Leucovorin 400 mg every two weeks
Interventions
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Irinotecan
d1 Irinotecan 180mg/m² every two weeks
Oxaliplatin
d1 Oxaliplatin 85 mg/m² every two weeks
5-FU
d1-2 5-FU 2200 mg/m² every two weeks
5-FU
d1 5-FU 250 mg/m² every two weeks
Leucovorin
d1 Leucovorin 400 mg every two weeks
5-FU
d1 5-FU 400 mg/m² every two weeks
5-FU
d1-2 5-FU 2400 mg/m² every two weeks
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
75 Years
ALL
Yes
Sponsors
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Blokhin's Russian Cancer Research Center
OTHER
Responsible Party
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Locations
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Blokhin's Russian Cancer Research Center
Moscow, , Russia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2020-01
Identifier Type: -
Identifier Source: org_study_id
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