Assessment of Metabolic and pathological Response to Treatment with Radio-chemotherapy (RCT) and Immunotherapy (ImT) before Surgery in locally advanced Esophageal and gastro-esophageal junction cancer: ARTemIS-Eso, a three-level, open-label, phase I-II study - ARTEMIS-Eso

Institut Jules Bordet0 sites100 target enrollmentMarch 17, 2017

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Adenocarcinomas of the esophagus or gastro-esophageal junction and squamous cell carcinoma of the esophagus.
Sponsor: Institut Jules Bordet
Enrollment: 100
Status: Active, not recruiting
Last Updated: 6 years ago

No summary available.

Registry

who.int

Start Date

March 17, 2017

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

Institut Jules Bordet

•1\.Age \= 18 years old
•2\.ECOG performance status \= 1
•3\.Female and Male
•4\.Must have histologically confirmed esophageal ADC or SCC or gastro\-esophageal junction ADC (Siewert I and II) eligible for a curative intent resection (recommended exploration by EUS and diagnostic laparoscopy in gastro\-esophageal junctions) without restriction in age and sex and candidate for neoadjuvant RCT.
•5\.At least classified clinical T3Nx or any T, N\+ according to cTNM version 7\.
•6\.Negative serum pregnancy test (for women of childbearing potential) within 7 (\+/\-1\) days prior to the beginning of treatment.
•7\.Women of childbearing potential must agree to use one highly effective method of contraception at study entry (if this is not already the case, put in place within 1 week after ICF signature, and at the very latest before 1st administration of study treatment), during the study treatment administration and at least 6 months after the last administration of study treatment.
•8\. Men must agree to use condom during the course of this study and for at least 6 months after the last administration of the study treatment.
•9\.Adequate bone marrow function as defined below:
•Absolute neutrophil count \=1500/µL or 1\.5x109/L

•1\.Patient ineligible for curative intent surgery:
•T4 with involvement of mediastinal structures as tracheobronchial, recurrent nerve, aorta over 90° of its circumference, vertebral body
•Tumour \= 4cm in diameter developed above the carina
•Visceral metastasis
•Metastatic lymph nodes: supraclavicular and/or lombo\-aortic
•Cervical esophageal cancer defined as a tumor involving the lower border of the cricoid cartilage (at the level of the sixth cervical vertebra) to the thoracic inlet 5cm down under, generally between 18 and 20 cm from the dental arcade
•2\.Uncontrolled concurrent illness or any significant disease that, in the investigator’s opinion, would exclude the patient from the study.
•3\.Absolute contraindication for surgery: respiratory failure (VEMS \< 1000mL), weight loss\> 20%, renal failure: creatinine \> 1\.5 ULN, myocardial infarct \< 6 months, evolutive cardiopathy, ECOG 3 and 4, non\-compensated cirrhosis.
•4\.Pregnant and/or lactating women.
•5\.Uncontrolled diabetes.