A Phase 2/3 interventional study of Docetaxel and Oxaliplatin in Gastric Cancer, Stomach Cancer and GastroEsophageal Cancer, sponsored by Ukrainian Society of Clinical Oncology. Recruiting at 2 sites in 2 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-05-06.
Sponsored by Ukrainian Society of Clinical Oncology · Phase 2/3, Interventional, and Treatment
The main goal of this study is to investigate the proportion of participants with locally advanced gastric and gastroesophageal adenocarcinoma without previous treatment during the last 5 years who can tolerate all planned cycles of chemotherapy and radical surgical treatment who will be prospectively randomized into two groups to undergo one of two chemotherapy regimens, followed by surgery:
This is a multi-center international European prospective randomized study that aims to enroll participants with resectable locally advanced gastric and gastroesophageal (Siewert 2, 3) adenocarcinoma (≥cT3 and/or ≥cN0 and M0) with no history of previous oncological treatment during the last five years, who will be included in this study after reading and signing the informed consent. After the initial diagnostic laparoscopy, patients will be randomized into two groups in a 1:1 ratio, with allocation to one of the two study groups.
Patients randomized to the first (control) group will receive eight cycles of the perioperative FLOT chemotherapy scheme: 4 cycles before surgical treatment and four cycles after surgical intervention. Patients randomized to the second (study) group will receive eight cycles of FLOT total neoadjuvant chemotherapy, followed by surgery.
The study's primary endpoint is the proportion of patients receiving all planned chemotherapy cycles and radical surgical treatment. Secondary endpoints are perioperative morbidity and mortality (surgical and chemotherapeutic complications); disease-free survival (DFS) and 1-, 3- and 5-years overall survival (OS); quality of life during and after the treatment; correlation between the pathohistological response and chemotherapy regimen; composition and biomarkers of gut microbiota; objective tumor response.
Based on previous studies, with the current standard treatment protocol-four cycles of FLOT chemotherapy before surgery and four cycles after-only 47% of patients complete all eight cycles. In contrast, with total neoadjuvant therapy, where the entire chemotherapy regimen is administered before surgery, 71% of patients are able to complete all eight FLOT cycles.
Given these findings, it was calculated that to ensure 80% study power with a two-sided 5% significance level, each study group should include 65 participants. Considering an expected dropout rate of 15%, a total of 150 patients will be recruited. Up to 40 patients will be enrolled in Vilnius, Lithuania, with the remaining participants recruited in Kyiv, Ukraine.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 150 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
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Exclusion Criteria:
4 cycles of neoadjuvant FLOT chemotherapy regimen, followed by surgery and 4 cycles of adjuvant FLOT chemotherapy regimen.
Drug: Docetaxel · Drug: Oxaliplatin · Drug: Leucovorin · Drug: Fluorouracil
8 cycles of total neoadjuvant FLOT chemotherapy regimen, followed by surgery.
Drug: Docetaxel · Drug: Oxaliplatin · Drug: Leucovorin · Drug: Fluorouracil
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
2600 mg/m²d1 i.v. every 2 weeks
All 8 planned FLOT cycles tolerance rate.
The proportion of patients receiving all planned cycles of chemotherapy and radical surgical treatment.
Time frame: From enrollment to the end of treatment at 12 weeks
Chemotherapy toxicity rate and profile.
To determine chemotherapeutic toxicity profile, according to Common Terminology Criteria for Adverse Events (CTCEA 5.0).
Time frame: At the end of each FLOT cycle (each cycle is 14 days), up to 14 days after the last cycle.
Surgical complications rate.
To determine postoperative surgical complications rate and profile after the different chemotherapy regimens, according to Clavien-Dindo classification.
Time frame: 30 days after surgery.
Median overall survival.
To determine the efficacy of TNT FLOT regimen compared to perioperative FLOT regimen by assessment of overall survival.
Time frame: From the start of treatment to the patient's death or the end of follow-up - 5 years follow-up after the last intervention.
Progression-free survival.
To determine the efficacy of total neoadjuvant FLOT regimen compared to perioperative FLOT regimen.
Time frame: Calculated as the time from the start of treatment to disease progression or the end of follow-up at 5 years after the treatment completion.
Quality of patients' life.
To determine the quality of life during the chemotherapy in both groups, after the surgery and 2 years follow-up after the treatment completion, assessed using a standardized European Organisation for Research and Treatment of Cancer quality-of-life questionnaire Core Questionnaire (EORTC QLQ-C30). Values from 30 to 126 mean a better or worse outcome, respectively.
Time frame: 24 months.
Quality of patients' life.
To determine the quality of life during the chemotherapy in both groups, after the surgery and 2 years follow-up after the completion of treatment, assessed using standardized European Organisation for Research and Treatment of Cancer quality-of-life questionnaires for Gastric Cancer (EORTC QLQ-STO22). Values from 22-88 mean a better or worse outcome, respectively.
Time frame: 24 months.
Correlation between the pathohistological response and overall and disease-free survival.
To determine the correlation between the pathohistological response and overall and progression-free survival, using the Becker criteria.
Time frame: 21 days after surgery.
Histopathological tumor response rate (Becker regression criteria).
To determine the pathohistological regression rate after 8 FLOT cycles in total neoadjuvant regimen compared to 4 FLOT cycles in neoadjuvant regimen.
Time frame: 21 days after surgery
Intestinal microbiome composition.
Significant differences in the alpha-diversity of the intestinal microbiome between patients with a good and poor response to neoadjuvant chemotherapy.
Time frame: Within 7 days before the start of the treatment.
Objective tumor response.
Assessed according to RECIST v1.1 criteria based on preoperative and control computed tomography.
Time frame: From within 7 days before the first chemotherapy course and until 4 weeks before the surgical intervention.
Plan to share: Yes — After the initial publication every participant will receive all the data to provide further data exploration.
Supporting information: Study protocol, Sap, Icf, Csr
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Ukrainian Society of Clinical Oncology