RecruitingPhase 2NCT05713838

Organ Preservation With Durvalumab-based Immunotherapy in Combination With Chemoradiation as Definitive Therapy for Early Stage Esophageal Adenocarcinoma With Indication for Radical Surgery

Organ Preservation With Durvalumab-based Immunotherapy in Combination With Chemoradiation as Definitive Therapy for Early Stage, cT1 and cT2N0, Esophageal Adenocarcinoma With Indication for Radical Surgery: A Prospective, Multicenter Study of the FLOT-AIO Gastric Cancer Group

Sponsor

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Enrollment

32 participants

Start Date

Aug 28, 2023

Study Type

INTERVENTIONAL

Conditions

Esophagus Adenocarcinoma

Summary

The present clinical trial is a prospective, investigator-initiated, single-arm, open-label, multicenter phase II trial investigating whether a definite organ preservation therapy consisting of the combination of durvalumab with chemoradiation is an efficient and safe treatment option for early stage, cT1 and cT2N0, esophageal adenocarcinoma with indication for radical surgery.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether an immunotherapy drug called durvalumab added to standard chemoradiation can eliminate early-stage esophageal cancer so effectively that surgery to remove the esophagus can be avoided (organ-sparing approach). **You may be eligible if...** - You are 18 or older with histologically confirmed esophageal or gastroesophageal junction adenocarcinoma - Your cancer is early stage (T1–T2, no spread to lymph nodes or distant organs) and you are scheduled for surgery - Your cancer is technically removable by surgery - You are in good physical health (ECOG 0–1) - You have not had prior chemotherapy or radiation for this cancer - You are willing to undergo a biopsy for PD-L1 testing before enrollment **You may NOT be eligible if...** - You have had prior esophageal or stomach surgery - You have serious autoimmune conditions - You are pregnant or breastfeeding - You have a pacemaker or certain implanted devices incompatible with treatment - You have active uncontrolled infections or significant liver/kidney problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDurvalumab

1500 mg Durvalumab, IV, day 1 Q4W (max. 15 cycles)

DRUGFLOT

50 mg/m² docetaxel, 85 mg/m² oxaliplatin, 200 mg/m² calcium folinate and 2600 mg/m² fluorouracil as 24 h-infusion, 2 cycles

DRUGmFOLFOX-6

85 mg/m² oxaliplatin, 200 mg/m² calcium folinate, 400 mg/m² fluorouracil as bolus dose and 1600 mg/m² fluorouracil as 48 h-infusion, ² cycles

RADIATIONRadiotherapy

5 weeks with 5 days a week radiotherapy (25 daily fractions with 2.0 Gy = ∑50Gy)

Locations(22)

Klinikum St. Marien Kommunalunternehmen - Anstalt des öffentlichen Rechts der Stadt Amberg

Amberg, Germany

HELIOS Klinikum Bad Saarow

Bad Saarow, Germany

Charite Univeristätsmedizin Berlin

Berlin, Germany

Universitätsklinikum Brandenburg an der Havel Medizinische Hochschule Brandenburg

Brandenburg an der Havel, Germany

Krankenhaus St. Joseph-Stift GmbH

Bremen, Germany

Klinikum Darmstadt GmbH

Darmstadt, Germany

Kliniken Essen Mitte Klinik für Internistische Onkologie und Hämatologie

Essen, Germany

Institute of Clinical Cancer Research, University Cancer Center (UCT) Frankfurt Krankenhaus Nordwest

Frankfurt, Germany

Universitätsmedizin Göttingen

Göttingen, Germany

Universitätsklinikum Halle (Saale) Universitätsklinik und Poliklinik für Innere Medizin I

Halle, Germany

Universitätsklinikum Heidelberg, RadioOnkologie & Strahlentherapie

Heidelberg, Germany

St. Elisabeth Gruppe GmbH, St. Anna Hospital Herne

Herne, Germany

Klinikverbund Allgäu gGmbH

Kempten, Germany

Universitätsklinikum Schleswig-Holstein

Kiel, Germany

ÜBAG - Medizinisches Versorgungszentrum Dr. Vehling-Kaiser GmbH

Landshut, Germany

Klinikum Ludwigshafen gGmbH

Ludwigshafen, Germany

Klinikum rechts der Isar der Technischen Universität München

München, Germany

Gemeinschaftspraxis für Hämatologie und Onkologie GEHO

Münster, Germany

Kreiskliniken Reutlingen GmbH Klinikum am Steinberg Reutlingen Ermstalklinik, Bad Urach

Reutlingen, Germany

Leopoldina-Krankenhaus Medizinische Klinik II

Schweinfurt, Germany

Klinikum Mutterhaus Trier

Trier, Germany

Klinikum Wolfsburg

Wolfsburg, Germany

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NCT05713838

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