Back to resultsFOLFIRINOX vs FLOT Chemotherapy for Resectable Gastric or Esophagogastric Junction Adenocarcinoma (RusGCG-01)
Primary Purpose
Stomach Neoplasms, Gastrointestinal Neoplasms, Docetaxel
Status
Recruiting
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
Irinotecan
5-FU
Leucovorin
Oxaliplatin
Docetaxel
Sponsored by
About this trial
This is an interventional treatment trial for Stomach Neoplasms focused on measuring gastric cancer, pathological complete, FLOT, FOLFIRINOX, gastrectomy, adenocarcinoma of the esophagogastric junction, adenocarcinoma of the stomach
Eligibility Criteria
Inclusion Criteria:
- 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
- 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 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
- 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
Sites / Locations
- Aleksei KalininRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
FOLFIRINOX
FLOT
Arm Description
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
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
Outcomes
Primary Outcome Measures
median overall survival
Secondary Outcome Measures
Pathologic complete response rate
Disease free survival
Perioperative Morbidity and Mortality
R0-Resection rate
Full Information
NCT ID
NCT04393584
First Posted
April 15, 2020
Last Updated
April 12, 2021
Sponsor
Blokhin's Russian Cancer Research Center
1. Study Identification
Unique Protocol Identification Number
NCT04393584
Brief Title
FOLFIRINOX vs FLOT Chemotherapy for Resectable Gastric or Esophagogastric Junction Adenocarcinoma
Acronym
RusGCG-01
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 29, 2019 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2026 (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
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
538 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
FOLFIRINOX
Arm Type
Experimental
Arm Description
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
Arm Title
FLOT
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Intervention Description
d1 Irinotecan 180mg/m² every two weeks
Intervention Type
Drug
Intervention Name(s)
5-FU
Intervention Description
d1-2 5-FU 2450 mg/m² every two weeks
Intervention Type
Drug
Intervention Name(s)
Leucovorin
Intervention Description
d1 Leucovorin 200 mg/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)
Docetaxel
Intervention Description
d1 Docetaxel 50mg/m2 every two weeks
Primary Outcome Measure Information:
Title
median overall survival
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Pathologic complete response rate
Time Frame
1 month after surgery
Title
Disease free survival
Time Frame
2 years
Title
Perioperative Morbidity and Mortality
Time Frame
1 months after surgery
Title
R0-Resection rate
Time Frame
1 month after surgery
10. Eligibility
Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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 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
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
Aleksei Kalinin, Phd
Phone
+79197681276
Email
kalininalexey1986@yandex.ru
First Name & Middle Initial & Last Name or Official Title & Degree
Sergey Nered, Phd
Phone
+79031995078
Email
nered@mail.ru
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ivan Stilidi, PhD
Organizational Affiliation
NN Blokhin National Medical Research Center of Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aleksei Kalinin
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aleksei Kalinin
Phone
+79197681276
Email
kalininalexey1986@yandex.ru
First Name & Middle Initial & Last Name & Degree
Ivan Stilidi, Phd
First Name & Middle Initial & Last Name & Degree
Sergey Nered, Phd
First Name & Middle Initial & Last Name & Degree
Aleksei Kalinin, Phd
First Name & Middle Initial & Last Name & Degree
Natalya Besova, Phd
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
FOLFIRINOX vs FLOT Chemotherapy for Resectable Gastric or Esophagogastric Junction Adenocarcinoma
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