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

NCT07791329 | Completed Phase 2

• 1 other identifier: MOU-2017-01
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

GastroPET is a prospective, multicenter, non-randomized interventional study evaluating sequential FDG-PET as an early biomarker to guide preoperative treatment in patients with locally advanced resectable oesophago-gastric adenocarcinoma. All patients receive an initial cycle of standard preoperative chemotherapy followed by a second FDG-PET scan. Based on the change in tumor FDG uptake, patients are classified as metabolic responders or non-responders. Metabolic responders continue preoperative chemotherapy, whereas metabolic non-responders switch to preoperative chemoradiotherapy. The study evaluates surgical and long-term outcomes of this response-adapted treatment strategy. Exploratory objectives include the evaluation of tissue and circulating miRNA and immune biomarkers in relation to metabolic response and treatment outcomes.

Conditions

Adenocarcinoma - Gastroesophageal Junction (GEJ); Gastric Adenocarcinoma; Gastroesophageal Junction (GEJ) Adenocarcinoma

Keywords

oesophago-gastric adenocarcinoma; FDG-PET; metabolic response; preoperative treatment; response-adapted treatment

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-PET DIAGNOSTIC_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 A; Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of 18 years or more
• Not currently participating in another study
• Able and willing to sign informed consent and to comply with study procedures
• Biopsy-proven locally advanced resectable oesophago-gastric adenocarcinoma (Siewert I - III) with T3N0, T4N0, T2 - T4N+, stage Ib - IIIc I. Adenocarcinoma of distal part of the oesophagus II. Adenocarcinoma of the real cardia III. Adenocarcinoma of the subcardial stomach
• Staging procedures include endoscopy, endoscopic ultrasound and FDG-PET
• Eligible patients have to be fit for platinum-containing chemotherapy
• Tumours must be potentially R0 resectable tumours during consecutive operation.

You may not qualify if:

• Participation in another clinical trial of a therapeutic drug during the past 14 days
• Addiction to alcohol or drugs
• Women of child-bearing potential who are not using a commonly accepted effective means of contraception; women of child-bearing potential will have negative blood pregnancy test before enrollment
• Pregnant women and nursing mothers are not allowed to enroll on this study
• Eastern Cooperative Oncology Group score \>2
• Previous or secondary malignancy in past 5 years (Excluding skin cancer and early cervical carcinoma)
• Life expectancy of less than 3 months
• Uncontrolled bleeding from the tumour
• Uncontrolled diabetes
• Patients are also ineligible if they have undergone previous chemotherapy, radiotherapy, or endoscopic laser therapy for EGJ

Sponsors & Collaborators

• Masaryk Memorial Cancer Institute: lead
• University Hospital Olomouc: collaborator
• General University Hospital, Prague: collaborator
• Masaryk University: collaborator

Study Sites (1)

Masaryk Memorial Cancer Institute

Brno, 65653, Czechia

Location

MeSH Terms

Conditions

Adenocarcinoma

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Regina Demlová, MD, PhD

  demlova@mou.cz

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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.

Study Record Dates

• First Submitted: August 6, 2017
• First Posted: August 27, 2026
• Study Start: August 1, 2018
• Primary Completion: October 1, 2020
• Study Completion: November 30, 2024
• Last Updated: August 27, 2026

Record last verified: 2026-08

Locations

CZ (1)