Gastric Cancer
Conditions
Keywords
gastric cancer, perioperative, FLOT, ECF, pathological complete remission, locally advanced resectable adenocarcinoma of the esophagogastric juction or the stomach
Brief summary
Patients with locally advanced resectable adenocarcinoma of the stomach or the esophagogastreal junction 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 Epirubicin, Cisplatin and 5-FU (ECF). Main objective of the study is median overall survival.
Detailed description
714 Patients with locally advanced resectable (T2-4 and/or N+, M0) adenocarcinoma of the stomach or the esophagogastreal junction without previous therapy will be included in this study. After randomization patients receive perioperatively 4 cycles FLOT or 3 cycles ECF, followed by a restaging of the tumour status and surgery. Subsequently another 4 cycles of FLOT or 3 cycles ECF are applicated. Then a central validation of the pathological remission rate is scheduled. Primary endpoint is overall survival, secondary endpoints are disease free survival, perioperative morbidity and mortality, histopathologic regression rate and R0-resection rate.
Interventions
DRUG5-Fluorouracil
2600 mg/m²d1 i.v. every 2 weeks
DRUGLeucovorin
200 mg/m², d1, i.v., every 2 weeks
DRUGOxaliplatin
85 mg/m², d1, i.v., every 2 weeks
DRUGDocetaxel
50mg/m2, d1, i.v., every 2 weeks
DRUGEpirubicin
50 mg/m2, d1, i.v., every 3 weeks
DRUGCisplatin
60 mg/m², d1, i.v., every 3 weeks
DRUG5-fluorouracil
200 mg/m², d1-d21, i.v., every 3 weeks
Sponsors
Krankenhaus Nordwest
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. locally advanced (\>T1) and/or nodal positive (N+) histologically proven adenocarcinoma of the esophagogastreal junction (AEG I-III) or the stomach without distant metastases (M0) and without infiltration of adjacent structures and organs 2. no previous surgical resection 3. no previous cytostatic chemotherapy 4. Age \> 18 years (female and male) 5. ECOG ≤ 2 6. surgical resectability 7. Exclusion of peritoneal carcinomatosis (if clinically suspected) via laparoscopy 8. Leucocytes \> 3.000/µl 9. Platelets \> 100.000/µl 10. Serum creatinin ≤ 1.5x of normal value, or Creatinin-Clearance \> 50 ml/min 11. written informed consent. 12. Ejection fraction \> 50% in echocardiography before start of therapy
Exclusion criteria
1. distant metastases or infiltration of adjacent structures or organs and all primarily not resectable stages 2. relapse 3. Hypersensitivity against 5- Fluorouracil, Leucovorin, Oxaliplatin, Cisplatin. Epirubicin and Docetaxel 4. Existence of contraindications against 5- Fluorouracil, Leucovorin, Oxaliplatin, Cisplatin, Epirubicin or Docetaxel 5. Active CHD, Cardiomyopathy or cardiac insufficiency stage III-IV according to NYHA 6. malignant secondary disease, dated back \< 5 years (exception: In-situ-carcinoma of the cervix uteri, adequately treated skin basal cell carcinoma) 7. severe non-surgical accompanying disease or acute infection 8. peripheral polyneuropathy \> NCI Grad II 9. severe liver dysfunction (AST/ALT\>3,5xULN, AP\>6xULN, Bilirubin\>1,5xULN) 10. chronic inflammable gastro-intestinal disease 11. inclusion in another clinical trial 12. pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| median overall survival | 2 years follow-up |
Secondary
| Measure | Time frame |
|---|---|
| histopathological regression rate | 6 weeks after surgery |
| disease free survival (DFS) | 2 years follow-up |
| correlation of pCR and DFS with survival | 2 years follow-up |
| Perioperative Morbidity and Mortality | up to 2 months after surgery |
| R0-Resection rate | 2 months after surgery |
Countries
Germany
Outcome results
None listed