NCT07791329CompletedPhase 2
Sequential FDG-PET and miRNA as Biomarkers of Preoperative Treatment Strategy in LA Oesophago-Gastric Cancer
Sequential FDG-PET and Plasma/Tissue miRNA as a Biomarkers of Preoperative Treatment Strategy in Locally Advanced Oesophago-Gastric Cancer
Source: ClinicalTrials.gov · Last updated 27 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 144 (actual)
- First submitted
- 6 Aug 2017
- Start date
- 1 Aug 2018
- Primary completion date
- 1 Oct 2020
- Lead sponsor
- Masaryk Memorial Cancer Institute
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT07791329
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 144
- From 1 Aug 2018 to the primary completion date, 1 Oct 2020
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in another clinical trial of a therapeutic drug during the past 14 days
- Addiction to alcohol or drugs
- Previous or secondary malignancy in past 5 years (Excluding skin cancer and early cervical carcinoma)
- Patients are also ineligible if they have undergone previous chemotherapy, radiotherapy, or endoscopic laser therapy for EGJ
Other illness
- Uncontrolled bleeding from the tumour
- Uncontrolled diabetes
Other
- 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
- Life expectancy of less than 3 months
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Masaryk Memorial Cancer Institute Coordinator of this site? Confirm its status | Brno | Czechia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.