NCT03307941

Assessment of Metabolic & Path Response w/ RCT & ImT Before Surgery in Locally Advanced Esoph and Gastro-esoph Jction CA

Assessment of Metabolic and Pathological Response to Treatment With RCT and ImT Before Surgery in Locally Advanced Esophageal and Gastro-esophageal Junction Cancer: ARTemIS-Eso, a Three-level, Open-label, Phase I-II Study

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Jules Bordet Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

ARTemIS-Eso is a phase I-II, three-level, open-label trial with a dose-expansion cohort at recommended schedule in both esophageal cancer histological groups (squamous cell carcinoma and adenocarcinoma) of RCT and ImT administered prior to surgery.

Detailed description

This study is indicated to patients with adenocarcinomas of the esophagus or gastro-esophageal junction and squamous cell carcinoma of the esophagus. The study consists of 2 parts: Phase I of the study is composed of the 3 following levels, corresponding to changes in the schedule and the number of administrations of monalizumab: Level 1: monalizumab (ImT) administration starts 2 weeks after the end of RCT (Total of 3 ImT doses). A maximum of 7 days delay is allowed. Level 2: monalizumab administration starts directly at the end of RCT (Total of 4 ImT doses). The first dose of monalizumab should be given on the following working day after the last radiotherapy administration. Level 3: monalizumab administration starts 2 weeks after the start of RCT (total of 6 ImT doses). A maximum of 7 days delay is allowed. Phase II (Expansion cohort): At the recommended level determined in phase I and according to the number of patients already accrued, approximately 48-51 additional patients (half-SCC and half-ADC) are included with the aim of assessing the activity of the recommended combination.

Conditions

• Adenocarcinoma of the Esophagus
• Adenocarcinoma of the Gastroesophageal Junction
• Squamous Cell Carcinoma of the Esophagus

Interventions

Type	Name	Description
DRUG	Monalizumab	Monalizumab (IPH2201) is given at the recommended dose of 10 mg/kg, intravenously (infusion during 60 minutes) every two weeks
DRUG	Oxaliplatin	A total of 4 cycles of FOLFOX is administrated every 2 weeks with one cycle 15 days prior to the radiotherapy and 3 cycles during the radiotherapy whatever the level
DRUG	5-Fluorouracil	A total of 4 cycles of FOLFOX is administrated every 2 weeks with one cycle 15 days prior to the radiotherapy and 3 cycles during the radiotherapy whatever the level
RADIATION	Metabolic	Radiation therapy must start the first day of FOLFOX chemotherapy. Radiation is given once daily for 5 consecutive days; on the days that the patient receives chemotherapy (and monalizumab when applicable), chemotherapy (and monalizumab) should be given prior to radiotherapy.
OTHER	Metabolic	18-FDG-PET scan will be performed just before the beginning of radio-chemotherapy (D10-D14) and will be blinded for investigators and patients. Another 18-FDG-PET will be performed before surgery (surgery Day-5 to surgery Day -1) to exclude metastatic evolution
PROCEDURE	Surgery	Surgery is performed preferably 8 weeks after the completion of the radio-chemotherapy, and it should not be performed less than one week after the last dose of monalizumab

Timeline

• Start date: 2017-07-20
• Primary completion: 2017-12-11
• Completion: 2017-12-11
• First posted: 2017-10-12
• Last updated: 2017-12-19

Locations

1 site across 1 country: Belgium