Folfox+Irinotecan+Chemort In Esophageal Cancer
In this research study, is studying how Liposomal Irinotecan in combination with the standard of care interventions FOLFOX, carboplatin paclitaxel, and radiation therapy affect gastroesophageal junction or esophagogastric cancer This research study involves the following study intervention: \- Liposomal irinotecan
| Condition(s) | Gastroesophageal Junction Adenocarcinoma, Esophagogastric Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | In this research study, is studying how Liposomal Irinotecan in combination with the standard of care interventions FOLFOX, carboplatin paclitaxel, and radiation therapy affect gastroesophageal junction or esophagogastric cancer This research study involves the following study intervention: \- Liposomal irinotecan |
| Who can participate | Inclusion Criteria: * Participants must meet all the following criteria in order to be eligible to participate in the study: * Histologically or cytologically confirmed T 3/4 or N+ (\> 1 cm in size or FDG avid) Siewart 1-3 gastroesophageal (GE) junction or esophagogastric cancer. Diagnosis must be confirmed by a DF/HCC institution pathology department prior to registration. * Age 18 years or older. There will be no upper age restriction. * ECOG performance status ≤ 1 * Life expectancy of greater than 3 months * Participants must have adequate organ and marrow function as defined below: * absolute neutrophil count ≥ 1,500 cells/mm3 * platelets ≥ 75,000 cells/mm3 * total bilirubin ≤ 1.5 x upper limit of normal OR for patients who have undergone biliary stenting, total bilirubin of ≤ 2.0 x up |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Massachusetts General Hospital |
| Locations | Boston, Massachusetts, United States; Boston, Massachusetts, United States; Newton, Massachusetts, United States |
| Start date | 2021-06-29 |
| NCT ID | NCT04656041 |
| Official listing | https://clinicaltrials.gov/study/NCT04656041 |