A Phase 2 interventional study of Oxaliplatin and Epirubicin in Adenocarcinoma of the Esophagogastric Junction, sponsored by Technical University of Munich. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-28.
Sponsored by Technical University of Munich · Phase 2, Interventional, and Treatment
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.
2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.
This study's enrollment of 75 is above the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.
Browse Adenocarcinoma studies →Technical University of Munich is the lead sponsor of 315 studies on the registry; 55 are open to participants now.
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bilirubin ≤ 1.5 times upper limit of normal , serum transaminases (GOT
/ GPT ) ≤ 3 times ULN
Exclusion Criteria:
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
Oxaliplatin Epirubicin Capecitabine 5-FU Biopsy
Drug: Oxaliplatin · Drug: Epirubicin · Drug: Capecitabine · Drug: 5-FU · Procedure: Biopsy
130 mg/m2
Also known as: Oxaliplan
50 mg/m2
Also known as: Epi Teva
625 mg/m2
Also known as: Xeloda
200 mg/m2
Also known as: 5-FU medac
2 mg/ml min
Also known as: Carboplatin SUN
50 mg/m2
Also known as: Taxomedac
total dosage 41,4 Gy
Also known as: intensitive neoadjuvant radiochemotherapy (INRCT)
translational analysis
Also known as: esophagogastroduodenoscopy
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)
Time frame: 1 day of surgery (in between day 28 to day 43 after radio-chemotherapy)
Regression
Histological regression defined by Becker Criteria
Time frame: 1 day of surgery (in between day 28 to day 43 after radio-chemotherapy)
Overall survival
Overall survival defined as period from start of study to death (if necessary censored by end of follow-up period)
Time frame: from day 0 to follow up visit 6 (24 months after surgery)
Disease-free survival
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"
Time frame: from day 0 to follow up visit 6 (24 months after surgery)
QLQ-C30
Quality of life, analyzed via EORTC QLQ-C30 questionnaires
Time frame: from day 0 to follow up visit 6 (24 months after surgery)
Metabilic response rate
Metabolic response rate under neoadjuvant chemotherapy
Time frame: from day 0 to one time point of time period day 14 to 28 after chemotherapy
Translational analysis
Translational analysis for identification of tumor determinants relevant for prognosis and therapy
Time frame: 1 day of surgery (in between day 28 to day 43 after radio-chemotherapy)
Adverse Events
Occurence of AEs
Time frame: from day 0 to follow up visit 6 (24 months after surgery)
QLQ-OG25
Quality of life, analyzed via EORTC QLQ-OG25 questionnaires
Time frame: from day 0 to follow up visit 6 (24 months after surgery)
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Technical University of Munich