Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma - Gastroesophageal Junction (GEJ) | — | UNRESOLVED | — |
| Gastric Adenocarcinoma | Gastric Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Gastroesophageal Junction (GEJ) Adenocarcinoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FDG-PET | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- 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
- interventionNames
- Diagnostic Test: FDG-PET
- type
- EXPERIMENTAL
- label
- Arm B
- description
- 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
- interventionNames
- Diagnostic Test: FDG-PET
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age of 18 years or more 2. Not currently participating in another study 3. Able and willing to sign informed consent and to comply with study procedures 4. 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 5. Staging procedures include endoscopy, endoscopic ultrasound and FDG-PET 6. Eligible patients have to be fit for platinum-containing chemotherapy 7. Tumours must be potentially R0 resectable tumours during consecutive operation. Exclusion Criteria: 1. Participation in another clinical trial of a therapeutic drug during the past 14 days 2. Addiction to alcohol or drugs 3. 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 4. Pregnant women and nursing mothers are not allowed to enroll on this study 5. Eastern Cooperative Oncology Group score \>2 6. Previous or secondary malignancy in past 5 years (Excluding skin cancer and early cervical carcinoma) 7. Life expectancy of less than 3 months 8. Uncontrolled bleeding from the tumour 9. Uncontrolled diabetes 10. Patients are also ineligible if they have undergone previous chemotherapy, radiotherapy, or endoscopic laser therapy for EGJ
References
Publications (0)
Data not yet available