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

NCT02287129 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2023-11-28

No results posted yet for this study

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

Interventions

DRUG

Oxaliplatin

130 mg/m2

DRUG

Epirubicin

50 mg/m2

DRUG

Capecitabine

625 mg/m2

DRUG

5-FU

200 mg/m2

DRUG

Carboplatin

2 mg/ml min

DRUG

Paclitaxel

50 mg/m2

RADIATION

radiation

total dosage 41,4 Gy

PROCEDURE

Biopsy

translational analysis

Sponsors & Collaborators

  • Technical University of Munich

    lead OTHER

Principal Investigators

  • Jens Siveke, Prof. Dr. · II. Medizinische Klinik, Klinikum rechts der Isar (MRI) der TUM,Ismaninger Str. 22

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-05
Primary Completion
2020-08-07
Completion
2020-08-07

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02287129 on ClinicalTrials.gov