Gastric Cancer Clinical Trial
— OCTASUROfficial title:
Total Neoadjuvant Chemotherapy With 5-fluoruracil, Leucovorin, Oxaliplatin and Docetaxel in Locally Advanced Gastric and Gastroesophageal Junction Cancer (OCTASUR): Randomized, Single Center, Open Label Trial, Phase 2/3
The main goal of this study is to investigate the histopathological regression rate in patients with locally advanced gastric and gastroesophageal adenocarcinoma without previous treatment who will be prospectively randomized into two groups to undergo one of two chemotherapy regimens, followed by surgery: 1. 8 cycles of Total Neoadjuvant ChemoTherapy (TNT) with 5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin and Docetaxel (FLOT) followed by surgery. 2. 4 cycles of Neoadjuvant FLOT chemotherapy scheme preoperatively and 4 adjuvant FLOT cycles postoperatively.
Status | Recruiting |
Enrollment | 758 |
Est. completion date | December 2031 |
Est. primary completion date | December 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Tumor spread: ?T3, ?T4a, ??4b (except of invasion of the common hepatic artery, celiac trunk, proximal part of the splenic artery, aorta, head of the pancreas); ?N1, ?N2, ?N3; ?M0; - Performance status by Eastern Cooperative Oncology Group (ECOG): 0 - 1; - Histological type of tumor: adenocarcinoma; - Differentiation grade: G0 - G4; - Tumor localization: cardio-esophageal junction (Siewert 2, 3), cardiac part of the stomach, body of the stomach, antral part of the stomach, pyloric part of the stomach; - Tumor extension: esophagus, diaphragm, liver, body and tail of the pancreas, anterior abdominal wall, small and large intestine, distal part of the splenic artery, spleen; - No history of cancer in the past 5 years; - Absence of previous chemotherapeutic, surgical or radiation treatment for oncological disease; - No concomitant severe comorbidity; - Patient willing to participate. Exclusion Criteria: - M1 (distant metastases); - ECOG 2 - 4; - Age over 80 and under 18; - Concomitant severe comorbidity; - Refusal of the patient to participate in the study. |
Country | Name | City | State |
---|---|---|---|
Ukraine | National Cancer Institute | Kyiv |
Lead Sponsor | Collaborator |
---|---|
Ukrainian Society of Clinical Oncology |
Ukraine,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 14 days after surgery | |
Secondary | Surgical complications rate. | To determine postoperative surgical complications rate and profile after the different chemotherapy regimens, according to Clavien-Dindo classification. | 30 days after surgery. | |
Secondary | Chemotherapy toxicity rate and profile. | To determine chemotherapeutic toxicity profile, according to Common Terminology Criteria for Adverse Events (CTCEA 5.0). | At the end of each FLOT cycle (each cycle is 14 days), up to 14 days after the last cycle. | |
Secondary | Quality of patients' life, according to the European Organisation for Research and Treatment of Cancer core quality of life questionnaire (EORTC QLQ-30, QLQ-OG25). | To determine quality of life during the chemotherapy in both groups, after the surgery and 2 years follow-up after the completion of treatment, using EORTC QLQ-30, QLQ-OG25 questionnaires. | 24 months. | |
Secondary | Disease-free survival. | To determine the efficacy of total neoadjuvant FLOT regimen compared to perioperative FLOT regimen. | 1 year after the last intervention. | |
Secondary | Median overall survival. | To determine the efficacy of TNT FLOT regimen compared to perioperative FLOT regimen by assessment of overall survival. | 5 years follow-up after the last intervention. | |
Secondary | Correlation between the pathohistological response and overall and disease-free survival. | To determine the correlation between the pathohistological response and overall and disease-free survival. | 14 days after surgery. |
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