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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
69
50mg/m2, d1, i.v., every 2 weeks
85 mg/m², d1, i.v., every 2 weeks
200 mg/m², d1, i.v., every 2 weeks
National Cancer Institute
Kyiv, Ukraine
Proportion of patients who complete all the treatment per protocol
Completed treatment protocol is considered as 4 cycles neoadjuvant chemotherapy followed by curative surgery and 4 cycles of adjuvant chemotherapy.
Time frame: Up to 2 months
Chemotherapy toxicity profile
To determine and compare toxicity profile in patients receiving XELOX or FLOT regimen
Time frame: at the end of XELOX cycle (each cycle is 21 days) and FLOT cycle (each cycle is 14 days)
Surgical complications rate
To determine surgical complication rate and profile after different types of regimens in neoadjuvant settings
Time frame: up to 90th day after surgery
1-year disease-free survival rate
To determine the efficacy of FLOT regimen compared to XELOX regimen during the first year after the surgery
Time frame: 1 year after surgery
Correlation between histopathological regression and disease-free survival
To determine correlation between histopathological regression and disease-free survival in different chemotherapeutic settings
Time frame: 2 years of follow-up after the last cycle of chemotherapy
Median overall survival
To determine the efficacy of FLOT regimen compared to XELOX regimen by assessment of overall survival
Time frame: 5 year follow up after the last cycle of chemotherapy
Histopathological regression rate (Becker regression criteria)
To determine histopathological regression rate after FLOT regimen compared to XELOX regimen in neoadjuvant settings
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2600 mg/m²d1 i.v. every 2 weeks
1000 mg/m² two times per day (BID), d1-14
130 mg/m² d1 i.v. every 3 weeks
Time frame: 2 weeks after surgery