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Oxaliplatin Epirubicin Capecitabine 5-FU Carboplatin Paclitaxel Radiation Biopsy

Oxaliplatin Epirubicin Capecitabine 5-FU Biopsy

5-FU

radiation

Biopsy

Jens Siveke, Prof. Dr.

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.

Adenocarcinomas of the esophagus and the esophagogastric junction (AEG) are clinically-topographically divided into subtypes I-III according to the Siewert classification and show an increased incidence. Neoadjuvant and/or perioperative chemotherapy or preoperative radiochemotherapy is well established in the management of AEG. However, a significant number of patients do not respond to preoperative chemotherapy, suffering from toxicity and facing a worse outcome due to lower R0 resection rates. Previous results from the MUNICON-1 and MUNICON-2 trials have shown that PET-based therapy individualization can be successfully integrated in neoadjuvant treatment algorithms.

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.

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

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)

Histological regression defined by Becker Criteria

Overall survival defined as period from start of study to death (if necessary censored by end of follow-up period)

Disease-free survival, defined as period from start of study to earlier occurring event: death or relapse until end of follow-up; Relapse will be separated into events of "local failure", "distant failure" and "local and distant failure"

Quality of life, analyzed via EORTC QLQ-C30 questionnaires

Metabolic response rate under neoadjuvant chemotherapy

Translational analysis for identification of tumor determinants relevant for prognosis and therapy

Quality of life, analyzed via EORTC QLQ-OG25 questionnaires

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation for the Individualization of Therapy in Adenocarcinomas of the Gastroesophageal Junction	NCT02287129	Adenocarcinoma ...	Oxaliplatin Epirubicin Capecitabine 5-FU Carboplatin Paclitaxel radiation Biopsy	18 Years -	Technical University of Munich
Evaluation for the Individualization of Therapy in Adenocarcinomas of the Gastroesophageal Junction	NCT02287129	Adenocarcinoma ...	Oxaliplatin Epirubicin Capecitabine 5-FU Carboplatin Paclitaxel radiation Biopsy	18 Years -	Technical University of Munich
Evaluation for the Individualization of Therapy in Adenocarcinomas of the Gastroesophageal Junction	NCT02287129	Adenocarcinoma ...	Oxaliplatin Epirubicin Capecitabine 5-FU Carboplatin Paclitaxel radiation Biopsy	18 Years -	Technical University of Munich

Spots Global Cancer Trial Database for intense fdg tracer uptake of the tumor