Stomach NeoplasmsPhase 2/3RusGCG-01NCT04393584
FOLFIRINOX vs FLOT Chemotherapy for Resectable Gastric or Esophagogastric Junction Adenocarcinoma
A Phase 2/3 study testing Irinotecan, 5-FU and Leucovorin in people with Stomach Neoplasms and Gastrointestinal Neoplasms, run by Blokhin's Russian Cancer Research Center at 1 site in Russia.
Trial summary
Patients with resectable 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 before and after surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Stomach Neoplasms, Gastrointestinal Neoplasms, Docetaxel
- What is being tested?
- Irinotecan, 5-FU and Leucovorin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 538 participants
- Where
- 1 siteRussia
- Study dates
- 29 Jan 2019to 1 Jan 2026
- Phase
- Phase 2/3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- сT4 cN0 or cT1-4 cN+ histologically proven adenocarcinoma of the esophagogastric junction (Siewert type II-III) or the stomach without distant metastases (M0)
- No previous cytostatic chemotherapy or radiation therapy
- Age 18-70 years (female and male)
- Eastern Cooperative Oncology Group ≤ 2
- Surgical resectability
- Neutrophils> 2.000/µl
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- 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.
Who cannot join
- Previous cytostatic chemotherapy or radiation therapy
- Distant metastases or all primarily not resectable stages
- 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, Epirubicin and Docetaxel
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- 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
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Aleksei Kalinin
Moscow, 115478
Aleksei Kalinin, +79197681276, kalininalexey1986@yandex.ru
Ivan Stilidi, Phd
About this study
Official title: Perioperative Chemotherapy With FOLFIRINOX Regimen or FLOT Regimen for Resectable Gastric or Esophagogastric Junction Adenocarcinoma (Type II-III): Open-label Randomized Phase 2/3 Trial
Patients with resectable 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 before and after surgery. One half of the patients gets 5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin and Docetaxel (FLOT), the others 5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin and Irinotecan (FOLFIRINOX). Main objective of the study is median overall survival.
Read the detailed description
538 Patients with resectable (cT4cN0 or cT1-4 and cN+, cM0) adenocarcinoma of the stomach or the esophagogastric junction without previous therapy will be included in this study. After randomization patients receive perioperatively 4 cycles FLOT or FOLFIRINOX, followed by a restaging of the tumour status and surgery. Subsequently another 4 cycles of FLOT or FOLFIRNOX are applicated.
- Conditions
- Stomach Neoplasms, Gastrointestinal Neoplasms, Docetaxel, Oxaliplatin, Fluoruracil, Irinotecan Hydrochloride
- Being tested
- Irinotecan, 5-FU, Leucovorin, Oxaliplatin, Docetaxel
- Keywords
- gastric cancer, pathological complete, FLOT, FOLFIRINOX, gastrectomy, adenocarcinoma of the esophagogastric junction, adenocarcinoma of the stomach
- Medical subject headings
- Stomach Neoplasms, Gastrointestinal 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
5-FUDrug
d1-2 5-FU 2450 mg/m² every two weeks
LeucovorinDrug
d1 Leucovorin 200 mg/m² every two weeks
OxaliplatinDrug
d1 Oxaliplatin 85 mg/m² every two weeks
DocetaxelDrug
d1 Docetaxel 50mg/m2 every two weeks
| Study group | Role | What they receive |
|---|---|---|
| FOLFIRINOX | Experimental | Irinotecan 180mg/m2 d1, d1-2 5-FU 2450 mg/m², d1 Leucovorin 200 mg/m², d1 Oxaliplatin 85 mg/m², d1 every two weeks (q2w) 4 cycles (4-8 weeks) pre-OP and 4 cycles (6-12 weeks) post-OP Receives: Drug: Irinotecan; Drug: 5-FU; Drug: Leucovorin; Drug: Oxaliplatin |
| FLOT | Active comparator | d1 Docetaxel 50mg/m2, d1-2 5-FU 2600 mg/m², d1 Leucovorin 200 mg/m², d1 Oxaliplatin 85 mg/m² every two weeks (q2w) 4 cycles (4-8 weeks) pre-OP and 4 cycles (6-12 weeks) post-OP Receives: Drug: 5-FU; Drug: Leucovorin; Drug: Oxaliplatin; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
median overall survival
Measured: 2 years
Secondary outcomes (4)
Pathologic complete response rate
Measured: 1 month after surgery
Disease free survival
Measured: 2 years
Perioperative Morbidity and Mortality
Measured: 1 months after surgery
R0-Resection rate
Measured: 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start29 Jan 2019
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach NeoplasmsStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 538 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Blokhin's Russian Cancer Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ivan Stilidi, PhD, Principal investigator, NN Blokhin National Medical Research Center of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04393584
- Sponsor's protocol ID
- 2019-01
- Acronym
- RusGCG-01
- Status last verified
- Apr 2021
- First submitted
- 15 Apr 2020
- Last updated
- 13 Apr 2021
- Results posted
- No
- 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
- Perioperative Chemotherapy With FOLFIRINOX Regimen or FLOT Regimen for Resectable Gastric or Esophagogastric Junction Adenocarcinoma (Type II-III): Open-label Randomized Phase 2/3 Trial
- ClinicalTrials.gov ID
- NCT04393584
- Acronym / sponsor ID
- RusGCG-01 / 2019-01
- Conditions
- Stomach Neoplasms, Gastrointestinal Neoplasms, Docetaxel, Oxaliplatin, Fluoruracil, Irinotecan Hydrochloride
- Keywords
- gastric cancer, pathological complete, FLOT, FOLFIRINOX, gastrectomy, adenocarcinoma of the esophagogastric junction, adenocarcinoma of the stomach
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 538 participants (estimated)
- Lead sponsor
- Blokhin's Russian Cancer Research CenterUniversity, hospital or other
- Study start
- 29 Jan 2019 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 19 May 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 resectable 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 before and after surgery. One half of the patients gets 5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin and Docetaxel (FLOT), the others 5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin and Irinotecan (FOLFIRINOX). Main objective of the study is median overall survival.
Detailed description
538 Patients with resectable (cT4cN0 or cT1-4 and cN+, cM0) adenocarcinoma of the stomach or the esophagogastric junction without previous therapy will be included in this study. After randomization patients receive perioperatively 4 cycles FLOT or FOLFIRINOX, followed by a restaging of the tumour status and surgery. Subsequently another 4 cycles of FLOT or FOLFIRNOX are applicated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FOLFIRINOX | Experimental | Drug: Irinotecan, Drug: 5-FU, Drug: Leucovorin, Drug: OxaliplatinIrinotecan 180mg/m2 d1, d1-2 5-FU 2450 mg/m², d1 Leucovorin 200 mg/m², d1 Oxaliplatin 85 mg/m², d1 every two weeks (q2w) 4 cycles (4-8 weeks) pre-OP and 4 cycles (6-12 weeks) post-OP |
| FLOT | Active comparator | Drug: 5-FU, Drug: Leucovorin, Drug: Oxaliplatin, Drug: Docetaxeld1 Docetaxel 50mg/m2, d1-2 5-FU 2600 mg/m², d1 Leucovorin 200 mg/m², d1 Oxaliplatin 85 mg/m² every two weeks (q2w) 4 cycles (4-8 weeks) pre-OP and 4 cycles (6-12 weeks) post-OP |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- сT4 cN0 or cT1-4 cN+ histologically proven adenocarcinoma of the esophagogastric junction (Siewert type II-III) or the stomach without distant metastases (M0)
- No previous cytostatic chemotherapy or radiation therapy
- Age 18-70 years (female and male)
- Eastern Cooperative Oncology Group ≤ 2
- Surgical resectability
Key exclusion criteria (20 listed)
- Previous cytostatic chemotherapy or radiation therapy
- Distant metastases or all primarily not resectable stages
- 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;
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 | FOLFIRINOX |
| 5-FUd1-2 5-FU 2450 mg/m² every two weeks | Drug | FLOT, FOLFIRINOX |
| Leucovorind1 Leucovorin 200 mg/m² every two weeks | Drug | FLOT, FOLFIRINOX |
| Oxaliplatind1 Oxaliplatin 85 mg/m² every two weeks | Drug | FLOT, FOLFIRINOX |
| Docetaxeld1 Docetaxel 50mg/m2 every two weeks | Drug | FLOT |
Primary outcome
median overall survival
Time frame: 2 years
4 secondary outcomes
Pathologic complete response rate
Time frame: 1 month after surgery
Disease free survival
Time frame: 2 years
Perioperative Morbidity and Mortality
Time frame: 1 months after surgery
R0-Resection rate
Time frame: 1 month after surgery
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.
Ivan Stilidi, PhD principal investigator
NN Blokhin National Medical Research Center of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Irinotecan, 5-FU and Leucovorin in people with Stomach Neoplasms and Gastrointestinal Neoplasms, 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 12 inclusion and 20 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Aleksei Kalinin, Phd (+79197681276, kalininalexey1986@yandex.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
median overall survival (time frame: 2 years). 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.