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

PHASE1/PHASE2WithdrawnINTERVENTIONAL
0
Timeline

Start Date

July 20, 2017

Primary Completion Date

December 11, 2017

Study Completion Date

December 11, 2017

Conditions
Adenocarcinoma of the EsophagusAdenocarcinoma of the Gastroesophageal JunctionSquamous Cell Carcinoma of the Esophagus
Interventions
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

Trial Locations (1)

1000

Institut Jules Bordet, Brussels

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Innate Pharma

INDUSTRY

lead

Jules Bordet Institute

OTHER