Esophagogastric Junction Adenocarcinoma Stage IV, Gastric Carcinoma Stage IV
Conditions
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.
Interventions
DRUGIrinotecan
d1 Irinotecan 180mg/m² every two weeks
DRUGOxaliplatin
d1 Oxaliplatin 85 mg/m² every two weeks
DRUG5-FU
d1-2 5-FU 2200 mg/m² every two weeks
DRUGLeucovorin
d1 Leucovorin 400 mg 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 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | 60 months | 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) | 12 months | — |
| Duration of Response | 12 months | — |
| Treatment associated toxicities | 12 months | WHO CTC 3.0 |
Countries
Russia
Contacts
Primary ContactTatiana Titova
Outcome results
None listed