Gastric Cancer
Conditions
Keywords
perioperative chemotherapy, pathological responce rate, gastrectomy, gastric cancer
Brief summary
Patients with resectable adenocarcinoma of stomach or esophagogastric junction without previous therapy will be treated with one of two chemotherapy regimens perioperatively. One group of the patients will receive 5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin and Docetaxel (FLOT), the second group will receive Oxaliplatin and Capecitabin (XELOX). Primary endpoint of the study is the proportion of patients who complete all allocated treatment.
Detailed description
328 рatients with resectable (T1b-4 and/or N-/+, M0) adenocarcinoma of the stomach or the esophagogastric junction without previous therapy will be included in this study. After staging laparocopy patients will be randomized to receive preoperatively 4 cycles FLOT or 4 cycles XELOX followed by curative surgery. Adjuvant chemotherapy will be given as 4 cycles of FLOT or 4 cycles XELOX. The primary endpoint is the proportion of patients who fully adhered to all the allocated treatment per protocol. Secondary endpoints are pathological regression grade, progression free survival, overall survival, chemotherapy and surgery complications rates.
Interventions
DRUGDocetaxel
50mg/m2, d1, i.v., every 2 weeks
DRUGOxaliplatin
85 mg/m², d1, i.v., every 2 weeks
DRUGLeucovorin
200 mg/m², d1, i.v., every 2 weeks
DRUGFluorouracil
2600 mg/m²d1 i.v. every 2 weeks
DRUGCapecitabine
1000 mg/m² two times per day (BID), d1-14
Sponsors
Ukrainian Society of Clinical Oncology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* cT1b-T4b (cT4b - invasion in diaphragm, parenchyma of liver, spleen, pancreas, abdominal wall, small bowel, colon, distal part of splenic artery) * cN0-3 * M0 * Age: 18 - 80 * ECOG: 0 - 1 * Histological type: adenocarcinoma * Differentiation grade: G0 - G4 * No previous surgery * No previous chemotherapy * No concomitant severe comorbidity * Written informed consent
Exclusion criteria
* cT1a, cT4b (invasion in truncus, hepatic artery, proximal part of splenic artery) * Presense of distant metastases * ECOG: 2 - 5 * Age: \<18 and \>80 * Severe concomitant comorbidity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients who complete all the treatment per protocol | Up to 2 months | Completed treatment protocol is considered as 4 cycles neoadjuvant chemotherapy followed by curative surgery and 4 cycles of adjuvant chemotherapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Histopathological regression rate (Becker regression criteria) | 2 weeks after surgery | To determine histopathological regression rate after FLOT regimen compared to XELOX regimen in neoadjuvant settings |
| Chemotherapy toxicity profile | at the end of XELOX cycle (each cycle is 21 days) and FLOT cycle (each cycle is 14 days) | To determine and compare toxicity profile in patients receiving XELOX or FLOT regimen |
| Median overall survival | 5 year follow up after the last cycle of chemotherapy | To determine the efficacy of FLOT regimen compared to XELOX regimen by assessment of overall survival |
| 1-year disease-free survival rate | 1 year after surgery | To determine the efficacy of FLOT regimen compared to XELOX regimen during the first year after the surgery |
| Correlation between histopathological regression and disease-free survival | 2 years of follow-up after the last cycle of chemotherapy | To determine correlation between histopathological regression and disease-free survival in different chemotherapeutic settings |
| Surgical complications rate | up to 90th day after surgery | To determine surgical complication rate and profile after different types of regimens in neoadjuvant settings |
Countries
Ukraine
Outcome results
None listed