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

NCT04442984 | Unknown Phase 2 DMC

• 1 other identifier: 2020-01
• Study Type: interventional
• Target: 326
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastric Carcinoma Stage IV; Esophagogastric Junction Adenocarcinoma Stage IV

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival

  PFS is defined as the time from the date of randomization to the date of the first documentation of progressive disease or date of death, whichever occurs first. For target lesions (TL), PD was defined as at least a 20 percent (%) increase in the sum of the longest diameter (SLD) of TLs, taking as a reference the smallest SLD recorded since the treatment started, or the appearance of one or more lesions. For non-target lesions (NTL), PD was defined as an unequivocal progression of existing NTLs. Participants were censored at the last date of tumor measurement, the last date in the study drug log, or the date of last follow-up.

  36 months

Secondary Outcomes (4)

• Overall Survival (OS)

  60 months

• Percentage of Participants With Confirmed Complete Response (CR) or Partial Response (PR) Determined by Response Evaluation Criteria in Solid Tumors (RECIST)

  12 months

• Duration of Response

  12 months

• Treatment associated toxicities

  12 months

Study Arms (2)

FOLFOX6

ACTIVE COMPARATOR

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

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

mFOLFIRINOX

EXPERIMENTAL

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

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

Interventions

Irinotecan DRUG

d1 Irinotecan 180mg/m² every two weeks

mFOLFIRINOX

Oxaliplatin DRUG

d1 Oxaliplatin 85 mg/m² every two weeks

FOLFOX6; mFOLFIRINOX

5-FU DRUG

d1-2 5-FU 2200 mg/m² every two weeks

mFOLFIRINOX

Leucovorin DRUG

d1 Leucovorin 400 mg every two weeks

FOLFOX6; mFOLFIRINOX

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• histologically confirmed locally advanced, recurrent or metastatic adenocarcinoma of the esophagogastric junction (Siewert type II-III) or the stomach
• no prior palliative chemotherapy or radiation therapy
• Age 18-70 years (female and male)
• Eastern Cooperative Oncology Group ≤ 2
• Neutrophils\> 2.000/µl
• Platelets \> 100.000/µl
• Normal value of Serum Creatinin
• Albumin level \> 29 г/л
• Aspartate transaminase (AST) or alanine transaminase (ALT) less than 3 times the upper limits of normal (ULN)
• Total Bilirubin less than 1.5 times the ULN
• Written informed consent.

You may not qualify if:

• Previous palliative cytostatic chemotherapy
• 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, irinotecan
• Existence of contraindications against 5- Fluorouracil, Leucovorin, Oxaliplatin, Irinotecan or Docetaxel
• Active coronary heart disease, Cardiomyopathy or cardiac insufficiency stage III-IV according to New York Heart Association (NYHA)
• 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)
• Malignant secondary disease, dated back \< 5 years (exception: In-situ-carcinoma of the cervix uteri, adequately treated skin basal cell carcinoma)
• Peripheral polyneuropathy \> Grad II
• Liver dysfunction (AST)/ALT\>3,0xULN, ALT\>3xULN, Bilirubin\>1,5xULN) Serum Creatinin \>1,0xULN
• Chronic inflammable gastro-intestinal disease
• Pregnancy or lactation
• Hepatitis B or C in the active stage
• Human immunodeficiency virus(HIV) infected

Sponsors & Collaborators

• Blokhin's Russian Cancer Research Center: lead

Study Sites (1)

Blokhin's Russian Cancer Research Center

Moscow, 115478, Russia

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Irinotecan; Oxaliplatin; Fluorouracil; Leucovorin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Coordination Complexes; Organic Chemicals; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Central Study Contacts

Tatiana Titova

CONTACT

+79152982811; tatiana.titovadoc@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2020
• First Posted: June 23, 2020
• Study Start: November 3, 2019
• Primary Completion: November 3, 2021
• Study Completion: November 3, 2024
• Last Updated: April 13, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)