Evaluation for the Individualization of Therapy in Adenocarcinomas of the Gastroesophageal Junction
NCT ID: NCT02287129
Last Updated: 2023-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
75 participants
INTERVENTIONAL
2014-12-05
2020-08-07
Brief Summary
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Detailed Description
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Tumor-free resection edges (R0) constitute the greatest prognostic advantage in terms of overall survival. However, the R0 resection rates for patients who, according to early metabolic response evaluation, have not responded to the chemotherapy, have not been satisfactory, even after conversion to an - albeit moderate - radiochemotherapy in the MUNICON-2 trial. Thus, this patient population (so-called non responders) so far lack a beneficial neoadjuvant therapy modality.
Based on these results, the primary goal of MEMORI study is to evaluate 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). Secondary it is planned to investigate 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
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Non-Responder
Oxaliplatin Epirubicin Capecitabine 5-FU Carboplatin Paclitaxel Radiation Biopsy
Oxaliplatin
130 mg/m2
Epirubicin
50 mg/m2
Capecitabine
625 mg/m2
5-FU
200 mg/m2
Carboplatin
2 mg/ml min
Paclitaxel
50 mg/m2
radiation
total dosage 41,4 Gy
Biopsy
translational analysis
Responder
Oxaliplatin Epirubicin Capecitabine 5-FU Biopsy
Oxaliplatin
130 mg/m2
Epirubicin
50 mg/m2
Capecitabine
625 mg/m2
5-FU
200 mg/m2
Biopsy
translational analysis
Interventions
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Oxaliplatin
130 mg/m2
Epirubicin
50 mg/m2
Capecitabine
625 mg/m2
5-FU
200 mg/m2
Carboplatin
2 mg/ml min
Paclitaxel
50 mg/m2
radiation
total dosage 41,4 Gy
Biopsy
translational analysis
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Technical University of Munich
OTHER
Responsible Party
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Principal Investigators
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Jens Siveke, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
II. Medizinische Klinik, Klinikum rechts der Isar (MRI) der TUM,Ismaninger Str. 22
Locations
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2nd department of the Medical Clinic of the Technical University Munich
Munich, Bavaria, Germany
Countries
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Other Identifiers
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MEM-0000-SIV-0028-I
Identifier Type: -
Identifier Source: org_study_id