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Outcome Measures

Primary Outcomes (1)

R0 resection rate in arm B (metabolic non-responders)
The proportion of patients in Arm B (metabolic non-responders) who achieve an R0 resection. Metabolic non-response is defined as a decrease in tumor standardized uptake value (SUV) of \<35% on FDG-PET performed after the first cycle of preoperative chemotherapy compared with baseline FDG-PET. R0 resection is defined as curative surgical resection with negative resection margins.
At surgery, following completion of preoperative treatment

Secondary Outcomes (2)

Overall survival in arm A and arm B
From the second FDG-PET scan until death from any cause, assessed up to 5 years
Disease free survival in arm A and arm B
From curative-intent resection (R0/R1) until disease recurrence or death from any cause, assessed up to 5 years

Study Arms (2)

Arm A

EXPERIMENTAL

Arm A = metabolic responders (showing ≥35% decrease of SUV) * Patients will continue with the same regimen: 4 cycles preoperative chemotherapy in FOLFOX/FLOT regimen * Surgery * Patients will receive 4 more cycles of FOLFOX/FLOT chemotherapy * Follow up

Diagnostic Test: FDG-PET

Arm B

EXPERIMENTAL

Arm B = metabolic non-responders (showing \< 35% decrease of SUV) * Patients will switch to the intensified preoperative chemoradiotherapy (45 Gy +paclitaxel/carboplatin): 5 cycles * Surgery * No following chemotherapy, follow up

Diagnostic Test: FDG-PET

Interventions

FDG-PETDiagnostic test

FDG-PET scans will be performed before (baseline) and after 14 days of standard neoadjuvant treatment in specialized PET centers (MOÚ Brno, VFN Praha, FN Olomouc) according to the standard operation procedure and in accordance with the EANM guidelines. Data and records of the FDG-PET scans will be sent for central reading to PET Center MOÚ. Tracer uptake will be assessed semiquantitatively (standardized uptake values (SUV) using a circular region of interest (ROI) (diameter, 1.5 cm) with the TrueD software (Siemens Medical Solutions)). The percentage change in SUV will be calculated as ΔSUV = 100 × (SUVbaseline - SUVfollow-up)/SUVbaseline and used to classify patients as metabolic responders or non-responders and guide subsequent preoperative treatment.

Arm AArm B

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Study Design

Study Type

interventional

Phase

phase 2

Allocation

NON RANDOMIZED

Masking

NONE

Purpose

DIAGNOSTIC

Intervention Model

PARALLEL

Model Details: The main objective is to use sequential FDG-PET/CT scans as an early biomarker. After the initial PET scan, all patients undergo one cycle of standard neoadjuvant chemotherapy. Exactly 14 days after this cycle, a second PET scan is performed, and its results (a decrease in SUV of ≥35% or \<35%) will determine assignment to one of two treatment arms. The study is classified as an interventional study, even though it does not use any investigational (experimental) drug. The intervention consists of modifying the treatment algorithm based on the PET scan results, whereby non-responders immediately switch from ineffective chemotherapy to preoperative chemoradiotherapy. All treatments administered (FLOT, FOLFOX, or chemoradiotherapy with paclitaxel and carboplatin) are in line with standard clinical practice according to international ESMO and NCCN guidelines.

Sponsor Type

OTHER

Responsible Party

SPONSOR

Sequential FDG-PET and miRNA as Biomarkers of Preoperative Treatment Strategy in LA Oesophago-Gastric Cancer

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Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Arm A

Arm B

Interventions

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Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

Primary Completion

Study Completion

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Arm A

Arm B

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations