Evaluation for the Individualization of Therapy in Adenocarcinomas of the Gastroesophageal Junction

NCT02287129 | Completed Phase 2

• 1 other identifier: MEM-0000-SIV-0028-I
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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

Adenocarcinoma of the Esophagogastric Junction

Keywords

Potentially R0 - resectable AEG and primary tumor category; Histologically confirmed AEG I-III; Functional operability; Intense FDG tracer uptake of the tumor

Outcome Measures

Primary Outcomes (1)

• R0 resection rate

  R0 resection rate of patients suffering from metabolically (following PET criteria) chemotherapy-resistant, locally advanced AEG, who receive a more intensive neoadjuvant radio-chemotherapy (INRCT)

  1 day of surgery (in between day 28 to day 43 after radio-chemotherapy)

Secondary Outcomes (8)

• Regression

  1 day of surgery (in between day 28 to day 43 after radio-chemotherapy)

• Overall survival

  from day 0 to follow up visit 6 (24 months after surgery)

• Disease-free survival

  from day 0 to follow up visit 6 (24 months after surgery)

• QLQ-C30

  from day 0 to follow up visit 6 (24 months after surgery)

• Metabilic response rate

  from day 0 to one time point of time period day 14 to 28 after chemotherapy

Study Arms (2)

Non-Responder

EXPERIMENTAL

Oxaliplatin Epirubicin Capecitabine 5-FU Carboplatin Paclitaxel Radiation Biopsy

Drug: Oxaliplatin; Drug: Epirubicin; Drug: Capecitabine; Drug: 5-FU; Drug: Carboplatin; Drug: Paclitaxel; Radiation: radiation; Procedure: Biopsy

Responder

ACTIVE COMPARATOR

Oxaliplatin Epirubicin Capecitabine 5-FU Biopsy

Drug: Oxaliplatin; Drug: Epirubicin; Drug: Capecitabine; Drug: 5-FU; Procedure: Biopsy

Interventions

Oxaliplatin DRUG

130 mg/m2

Also known as: Oxaliplan

Non-Responder; Responder

Epirubicin DRUG

50 mg/m2

Also known as: Epi Teva

Non-Responder; Responder

Capecitabine DRUG

625 mg/m2

Also known as: Xeloda

Non-Responder; Responder

5-FU DRUG

200 mg/m2

Also known as: 5-FU medac

Non-Responder; Responder

Carboplatin DRUG

2 mg/ml min

Also known as: Carboplatin SUN

Non-Responder

Paclitaxel DRUG

50 mg/m2

Also known as: Taxomedac

Non-Responder

radiation RADIATION

total dosage 41,4 Gy

Also known as: intensitive neoadjuvant radiochemotherapy (INRCT)

Non-Responder

Biopsy PROCEDURE

translational analysis

Also known as: esophagogastroduodenoscopy

Non-Responder; Responder

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed AEG I-III
• Potentially R0 - resectable AEG and primary tumor category UT2 -4
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (1)

2nd department of the Medical Clinic of the Technical University Munich

Munich, Bavaria, 81675, Germany

Location

MeSH Terms

Interventions

Oxaliplatin; Epirubicin; Capecitabine; Fluorouracil; Carboplatin; Paclitaxel; Radiation; Biopsy; Endoscopy, Digestive System

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes; Physical Phenomena; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Diagnostic Techniques, Digestive System; Endoscopy; Digestive System Surgical Procedures; Minimally Invasive Surgical Procedures

Study Officials

• Jens Siveke, Prof. Dr.

  II. Medizinische Klinik, Klinikum rechts der Isar (MRI) der TUM,Ismaninger Str. 22

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2014
• First Posted: November 10, 2014
• Study Start: December 5, 2014
• Primary Completion: August 7, 2020
• Study Completion: August 7, 2020
• Last Updated: November 28, 2023

Record last verified: 2023-11

Locations

DE (1)