Docetaxel, Fluoruracil, Gastrointestinal Neoplasms, Irinotecan Hydrochloride, Oxaliplatin, Stomach Neoplasms
Conditions
Keywords
gastric cancer, pathological complete, FLOT, FOLFIRINOX, gastrectomy, adenocarcinoma of the esophagogastric junction, adenocarcinoma of the stomach
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.
Interventions
DRUGIrinotecan
d1 Irinotecan 180mg/m² every two weeks
DRUG5-FU
d1-2 5-FU 2450 mg/m² every two weeks
DRUGLeucovorin
d1 Leucovorin 200 mg/m² every two weeks
DRUGOxaliplatin
d1 Oxaliplatin 85 mg/m² every two weeks
DRUGDocetaxel
d1 Docetaxel 50mg/m2 every two weeks
Sponsors
Blokhin's Russian Cancer Research Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. сT4 cN0 or cT1-4 cN+ histologically proven adenocarcinoma of the esophagogastric junction (Siewert type II-III) or the stomach without distant metastases (M0) 2. No previous cytostatic chemotherapy or radiation therapy 3. Age 18-70 years (female and male) 4. Eastern Cooperative Oncology Group ≤ 2 5. Surgical resectability 6. Neutrophils\> 2.000/µl 7. Platelets \> 100.000/µl 8. Normal value of Serum Creatinin 9. Albumin level \> 29 г/л 10. Aspartate transaminase (AST) or alanine transaminase (ALT) less than 3 times the upper limits of normal (ULN) 11. Total Bilirubin less than 1.5 times the ULN 12. Written informed consent.
Exclusion criteria
1. Previous cytostatic chemotherapy or radiation therapy 2. Distant metastases or all primarily not resectable stages 3. Cancer relapse 4. Complicated gastric cancer (perforation, bleeding, sub or decompensated stenosis, dysphagia IV) 5. Diarrhea ≥ 2 according to the criteria of Common Terminology Criteria for Adverse Events (CTCAE) version 4.1; 6. Hypersensitivity against 5- Fluorouracil, Leucovorin, Oxaliplatin, Epirubicin and Docetaxel 7. Existence of contraindications against 5- Fluorouracil, Leucovorin, Oxaliplatin, Irinotecan or Docetaxel 8. Active coronary heart disease, Cardiomyopathy or cardiac insufficiency stage III-IV according to New York Heart Association (NYHA) 9. 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) 10. Malignant secondary disease, dated back \< 5 years (exception: In-situ-carcinoma of the cervix uteri, adequately treated skin basal cell carcinoma) 11. Peripheral polyneuropathy \> Grad II 12. Liver dysfunction (AST)/ALT\>3,0xULN, ALT\>3xULN, Bilirubin\>1,5xULN) 13. Serum Creatinin \>1,0xULN 14. Chronic inflammable gastro-intestinal disease 15. Inclusion in another clinical trial 16. Pregnancy or lactation 17. Hepatitis B or C in the active stage 18. Human immunodeficiency virus(HIV) infected 19. 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 20. Foreigners or persons with limited legal status
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| median overall survival | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Pathologic complete response rate | 1 month after surgery |
| Disease free survival | 2 years |
| Perioperative Morbidity and Mortality | 1 months after surgery |
| R0-Resection rate | 1 month after surgery |
Countries
Russia
Contacts
Primary ContactAleksei Kalinin, Phd
Backup ContactSergey Nered, Phd
Outcome results
None listed