Clinical trial · Interventional
Evaluation for the Individualization of Therapy in Adenocarcinomas of the Gastroesophageal Junction
Metabolic and Molecular Response Evaluation for the Individualization of Therapy in Adenocarcinomas of the Gastroesophageal Junction
- 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)
Metabolic and Molecular Response evaluation for the individualization of therapy in adenocarcinomas of the gastroesophageal junction by evaluation of the R0 resection rate for patients with metabolically (ie, according to PET criteria) chemotherapy-resistant locally advanced AEG, who receive an intensified neoadjuvant chemoradiotherapy (INRCT). Additonal efforts will be done by investigation of molecular and metabolic biomarkers in relation to their predictive and prognostic value by correlating them with histopathologic responses and clinical outcome in an exploratory approach.
Conditions
Conditions (1)
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 of the Esophagogastric Junction | Gastroesophageal Junction Adenocarcinoma | ALIAS | 0.90 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-FU | Drug | Fluorouracil | ALIAS |
| Biopsy | Procedure | — | UNRESOLVED |
| Capecitabine | Drug | Capecitabine | ALIAS |
| Carboplatin | Drug | Carboplatin | ALIAS |
| Epirubicin | Drug | Epirubicin | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Non-Responder
- description
- Oxaliplatin Epirubicin Capecitabine 5-FU Carboplatin Paclitaxel Radiation Biopsy
- interventionNames
- Drug: Oxaliplatin
- Drug: Epirubicin
- Drug: Capecitabine
- Drug: 5-FU
- Drug: Carboplatin
- Drug: Paclitaxel
- Radiation: radiation
- Procedure: Biopsy
- type
- ACTIVE_COMPARATOR
- label
- Responder
- description
- Oxaliplatin Epirubicin Capecitabine 5-FU Biopsy
- interventionNames
- Drug: Oxaliplatin
- Drug: Epirubicin
- Drug: Capecitabine
- Drug: 5-FU
- Procedure: Biopsy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed AEG I-III * Potentially R0 - resectable AEG and primary tumor category UT2 -4 * Functional operability : Exclusion of OP - limiting comorbidities * Intense FDG tracer uptake of the tumor during Baseline PET/CT examination and thus suitability for monitoring and early response prediction by FDG - PET ( \[ 18F \] - FDG uptake in the tumor at baseline \> 1.35 x liver SUV + 2 x standard deviation of the liver SUV) * Performance status (ECOG ) 0 or 1 * Age : ≥ 18 * creatinine clearance \> 60ml/min measured in a 24 h urine or calculated with the Cockgroft -Gault formula * bilirubin ≤ 1.5 times upper limit of normal , serum transaminases (GOT / GPT ) ≤ 3 times ULN * leukocytes ≥ 3.5 g / l, platelet ≥ 100 g / l * Negative pregnancy test (determination of beta- HCG in urine or serum) in women of childbearing potential * A signed consent form after implementation of medical education Exclusion Criteria: * Existing distant metastases (M1b) * Tumor infiltration into the tracheobronchial system * Previous radiotherapy targeted at the thorax * Lack of ability of the patient to adhere to the protocol rules * Manifest heart failure despite optimal medication\> NYHA I * existing angina pectoris at rest or undergoing stress without clarification via interventional cardiology and / or myocardial infarction within the last 6 months * Existing pregnancy or lactation * childbearing or fertility without using recognized safe methods of contraception * Coexisting other malignant diseases with the exception of a non-melanomatuous, localized skin tumor or carcinoma in situ of the cervix * absence of a signed consent form
References
Publications (0)
Data not yet available