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

Primary Purpose

Gastric Carcinoma Stage IV, Esophagogastric Junction Adenocarcinoma Stage IV

Status
Recruiting
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
Irinotecan
Oxaliplatin
5-FU
5-FU
Leucovorin
5-FU
5-FU
Sponsored by
Blokhin's Russian Cancer Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Carcinoma Stage IV

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Blokhin's Russian Cancer Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

FOLFOX6

mFOLFIRINOX

Arm 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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall Survival (OS)
OS is defined as the time from the date of randomization to the date of death due to any cause. 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
Percentage of Participants With Confirmed Complete Response (CR) or Partial Response (PR) Determined by Response Evaluation Criteria in Solid Tumors (RECIST)
Duration of Response
Treatment associated toxicities
WHO CTC 3.0

Full Information

First Posted
June 17, 2020
Last Updated
April 11, 2021
Sponsor
Blokhin's Russian Cancer Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT04442984
Brief Title
FOLFOX6 Versus mFOLFIRINOX as First Line Chemotherapy in Metastatic Gastric Cancer or Esophagogastric Junction Adenocarcinoma (Type II-III)
Acronym
IRIGA
Official Title
FOLFOX6 Versus mFOLFIRINOX as First Line Chemotherapy in Metastatic Gastric or Esophagogastric Junction Adenocarcinoma (Type II-III): Open-label Randomized Phase 2/3 Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 3, 2019 (Actual)
Primary Completion Date
November 3, 2021 (Anticipated)
Study Completion Date
November 3, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Blokhin's Russian Cancer Research Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Carcinoma Stage IV, Esophagogastric Junction Adenocarcinoma Stage IV

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
326 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FOLFOX6
Arm Type
Active Comparator
Arm 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
Arm Title
mFOLFIRINOX
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Intervention Description
d1 Irinotecan 180mg/m² every two weeks
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
d1 Oxaliplatin 85 mg/m² every two weeks
Intervention Type
Drug
Intervention Name(s)
5-FU
Intervention Description
d1-2 5-FU 2200 mg/m² every two weeks
Intervention Type
Drug
Intervention Name(s)
5-FU
Intervention Description
d1 5-FU 250 mg/m² every two weeks
Intervention Type
Drug
Intervention Name(s)
Leucovorin
Intervention Description
d1 Leucovorin 400 mg every two weeks
Intervention Type
Drug
Intervention Name(s)
5-FU
Intervention Description
d1 5-FU 400 mg/m² every two weeks
Intervention Type
Drug
Intervention Name(s)
5-FU
Intervention Description
d1-2 5-FU 2400 mg/m² every two weeks
Primary Outcome Measure Information:
Title
Progression-Free Survival
Description
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.
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS is defined as the time from the date of randomization to the date of death due to any cause. 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
Time Frame
60 months
Title
Percentage of Participants With Confirmed Complete Response (CR) or Partial Response (PR) Determined by Response Evaluation Criteria in Solid Tumors (RECIST)
Time Frame
12 months
Title
Duration of Response
Time Frame
12 months
Title
Treatment associated toxicities
Description
WHO CTC 3.0
Time Frame
12 months

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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 Inclusion in another clinical trial Pregnancy or lactation Hepatitis B or C in the active stage Human immunodeficiency virus(HIV) infected 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 Foreigners or persons with limited legal status
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tatiana Titova
Phone
+79152982811
Email
tatiana.titovadoc@gmail.com
Facility Information:
Facility Name
Blokhin's Russian Cancer Research Center
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tatiana Titova
Phone
+79152982811
Email
tatiana.titovadoc@gmail.com
First Name & Middle Initial & Last Name & Degree
Artamonova Elena

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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