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Adenocarcinoma - Gastroesophageal Junction (GEJ)Phase 2GastroPETNCT07791329

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

A Phase 2 study testing FDG-PET in people with Adenocarcinoma - Gastroesophageal Junction (GEJ) and Gastric Adenocarcinoma, run by Masaryk Memorial Cancer Institute at 1 site in Czechia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
FDG-PET
Could I receive a placebo?
No, everyone receives an active treatment
How many people
144 participants
Where
1 siteCzechia
Study dates
1 Aug 2018to 30 Nov 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Czechia1 site

  • Masaryk Memorial Cancer Institute

    Brno, 65653

Other trials in Czechia

About this study

Official title: Sequential FDG-PET and Plasma/Tissue miRNA as a Biomarkers of Preoperative Treatment Strategy in Locally Advanced Oesophago-Gastric Cancer

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.

Read the detailed description

The primary objective of the study is to evaluate sequential FDG-PET as an early biomarker for response-adapted preoperative treatment in locally advanced resectable oesophago-gastric adenocarcinoma. FDG-PET is performed before initiation of preoperative chemotherapy and after the first cycle of chemotherapy. The change in tumor standardized uptake value (SUV) is used to classify patients as metabolic responders (Arm A) or metabolic non-responders (Arm B).

Metabolic responders continue preoperative FLOT or FOLFOX chemotherapy, whereas metabolic non-responders switch to preoperative chemoradiotherapy with paclitaxel and carboplatin. The primary efficacy outcome is the R0 resection rate in Arm B. Secondary clinical outcomes include disease-free survival and overall survival in both metabolic response groups.

Additional exploratory objectives include the evaluation of tissue and plasma miRNA profiles as biomarkers of metabolic and pathological response, assessment of circulating immune cells and antibody profiles in relation to metabolic response and treatment outcomes, and a pharmacokinetic substudy evaluating interpatient variability in fluoropyrimidine exposure and its association with adverse drug reactions.

Being tested
FDG-PET
Keywords
oesophago-gastric adenocarcinoma, FDG-PET, metabolic response, preoperative treatment, response-adapted treatment
Medical subject headings
Adenocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT07791329
Study groupRoleWhat they receive
Arm AExperimentalArm 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
Receives: Diagnostic Test: FDG-PET
Arm BExperimentalArm 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
Receives: Diagnostic Test: FDG-PET

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At surgery, following completion of preoperative treatment

Secondary outcomes (2)

  1. Overall survival in arm A and arm B

    Overall survival (OS) is defined as the time from the second FDG-PET scan to death from any cause. OS will be evaluated in Arm A (metabolic responders) and Arm B (metabolic non-responders).

    Measured: From the second FDG-PET scan until death from any cause, assessed up to 5 years

  2. Disease free survival in arm A and arm B

    Disease-free survival (DFS) is defined as the time from curative-intent resection (R0/R1) to disease recurrence or death from any cause. DFS will be evaluated separately in Arm A (metabolic responders) and Arm B (metabolic non-responders).

    Measured: From curative-intent resection (R0/R1) until disease recurrence or death from any cause, assessed up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2026
  2. Study start1 Aug 2018
  3. Primary completion1 Oct 2020
  4. Study completion30 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
144 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07791329
Sponsor's protocol ID
MOU-2017-01
Acronym
GastroPET
Status last verified
Aug 2026
First submitted
6 Aug 2017
Last updated
27 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FDG-PET in people with Adenocarcinoma - Gastroesophageal Junction (GEJ) and Gastric Adenocarcinoma, run by Masaryk Memorial Cancer Institute at 1 site in Czechia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

R0 resection rate in arm B (metabolic non-responders) (time frame: At surgery, following completion of preoperative treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07791329.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.

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