Gastric Carcinoma Stage IVPhase 2IRIGANCT04442984
FOLFOX6 Versus mFOLFIRINOX as First Line Chemotherapy in Metastatic Gastric Cancer or Esophagogastric Junction Adenocarcinoma (Type II-III)
A Phase 2 study testing Irinotecan, Oxaliplatin and 5-FU in people with Gastric Carcinoma Stage IV and Esophagogastric Junction Adenocarcinoma Stage IV, run by Blokhin's Russian Cancer Research Center at 1 site in Russia.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastric Carcinoma Stage IV, Esophagogastric Junction Adenocarcinoma Stage IV
- What is being tested?
- Irinotecan, Oxaliplatin and 5-FU
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 326 participants
- Where
- 1 siteRussia
- Study dates
- 3 Nov 2019to 3 Nov 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Blokhin's Russian Cancer Research Center
Moscow, 115478
Tatiana Titova, +79152982811, tatiana.titovadoc@gmail.com
Artamonova Elena
About this study
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
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.
Read the 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.
- Being tested
- Irinotecan, Oxaliplatin, 5-FU, Leucovorin
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IrinotecanDrug
d1 Irinotecan 180mg/m² every two weeks
OxaliplatinDrug
d1 Oxaliplatin 85 mg/m² every two weeks
5-FUDrug
d1-2 5-FU 2200 mg/m² every two weeks
5-FUDrug
d1 5-FU 250 mg/m² every two weeks
LeucovorinDrug
d1 Leucovorin 400 mg every two weeks
5-FUDrug
d1 5-FU 400 mg/m² every two weeks
5-FUDrug
d1-2 5-FU 2400 mg/m² every two weeks
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Irinotecan; Drug: Oxaliplatin; Drug: 5-FU; Drug: Leucovorin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 36 months
Secondary outcomes (4)
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
Measured: 60 months
Percentage of Participants With Confirmed Complete Response (CR) or Partial Response (PR) Determined by Response Evaluation Criteria in Solid Tumors (RECIST)
Measured: 12 months
Duration of Response
Measured: 12 months
Treatment associated toxicities
WHO CTC 3.0
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start3 Nov 2019
- Primary completion3 Nov 2021 (estimated)
- Study completion3 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Carcinoma Stage IVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 326 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Blokhin's Russian Cancer Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04442984
- Sponsor's protocol ID
- 2020-01
- Acronym
- IRIGA
- Status last verified
- Apr 2021
- First submitted
- 17 Jun 2020
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04442984
- Acronym / sponsor ID
- IRIGA / 2020-01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 326 participants (estimated)
- Lead sponsor
- Blokhin's Russian Cancer Research CenterUniversity, hospital or other
- Study start
- 3 Nov 2019 (actual)
- Primary completion
- 3 Nov 2021 (estimated)
- Study completion
- 3 Nov 2024 (estimated)
- First posted
- 23 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FOLFOX6 | Active comparator | Drug: Oxaliplatin, Drug: Leucovorin, Drug: 5-FU5FU 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 |
| mFOLFIRINOX | Experimental | Drug: Irinotecan, Drug: Oxaliplatin, Drug: 5-FU, Drug: LeucovorinIrinotecan 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Irinotecand1 Irinotecan 180mg/m² every two weeks | Drug | mFOLFIRINOX |
| Oxaliplatind1 Oxaliplatin 85 mg/m² every two weeks | Drug | FOLFOX6, mFOLFIRINOX |
| 5-FUd1-2 5-FU 2200 mg/m² every two weeks | Drug | mFOLFIRINOX |
| 5-FUd1 5-FU 250 mg/m² every two weeks | Drug | mFOLFIRINOX |
| Leucovorind1 Leucovorin 400 mg every two weeks | Drug | FOLFOX6, mFOLFIRINOX |
| 5-FUd1 5-FU 400 mg/m² every two weeks | Drug | FOLFOX6 |
| 5-FUd1-2 5-FU 2400 mg/m² every two weeks | Drug | FOLFOX6 |
Primary outcome
Progression-Free Survival
Time frame: 36 months
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.
4 secondary outcomes
Overall Survival (OS)
Time frame: 60 months
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
Duration of Response
Time frame: 12 months
Treatment associated toxicities
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Irinotecan, Oxaliplatin and 5-FU in people with Gastric Carcinoma Stage IV and Esophagogastric Junction Adenocarcinoma Stage IV, run by Blokhin's Russian Cancer Research Center at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tatiana Titova (+79152982811, tatiana.titovadoc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2021.