Clinical trial NCT04937738: Perioperative Chemotherapy in Gastric Cancer
Official title: Treatment Discontinuation Associated With Perioperative Toxicity of FLOT Versus XELOX Chemotherapy in Patient With Resectable Gastric Cancer; Phase 2
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Gastric Cancer
Keywords: perioperative chemotherapy
pathological responce rate
gastrectomy
gastric cancer
Lead sponsor: Ukrainian Society of Clinical Oncology
Sponsor class: OTHER
First posted: 2021-06-24
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients who complete all the treatment per protocol
timeFrame: Up to 2 months
Secondary outcomes:
measure: Chemotherapy toxicity profile
timeFrame: at the end of XELOX cycle (each cycle is 21 days) and FLOT cycle (each cycle is 14 days)
measure: Surgical complications rate
timeFrame: up to 90th day after surgery
measure: 1-year disease-free survival rate
timeFrame: 1 year after surgery
measure: Correlation between histopathological regression and disease-free survival
timeFrame: 2 years of follow-up after the last cycle of chemotherapy
measure: Median overall survival
timeFrame: 5 year follow up after the last cycle of chemotherapy
measure: Histopathological regression rate (Becker regression criteria)
timeFrame: 2 weeks after surgery
Other outcomes:
Locations:
city: Kyiv
country: Ukraine
facility: National Cancer Institute
Study officials:
affiliation: National Cancer Institute (NCI)
name: Oleksii Dobrzhanskyi, MD
role: PRINCIPAL_INVESTIGATOR
References: