A Phase II Study of Neoadjuvant NAPOX Followed by Chemoradiation With Paclitaxel and Carboplatin in Locally Advanced Esophagogastric Cancer
Massachusetts General Hospital
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
Description
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. This research study involves the following standard of care interventions: * FOLFOX (leucovorin calcium, 5-Fluorouracil, and oxaliplatin) * Carboplatin * Paclitaxel * Radiation therapy This research study involves the following study intervention: \- Liposomal irinotecan It is expected that about 40 people will take part in this research study. This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an inve…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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: * a…
Interventions
- DrugFOLFOX/ nal-IRI
A cycle will be two weeks (14 days) long, with FOLFOX/ nal-IRI administered on days 1-3. The order of FOLFOX/ nal-IRI administration is as follows: * 1\) Liposomal Irinotecan free base via IV, predetermined dosage per protocol * 2\) Oxaliplatin via IV, predetermined dosage per protocol * 3\) Leucovorin via IV, predetermined dosage per protocol * 4\) 5-Fluorouracil via IV, predetermined dosage per protocol
- DrugPaclitaxel
Paclitaxel and Carboplatin will be given concurrently with radiation therapy weekly (+/- 1 day).
- DrugCarboplatin
Paclitaxel and Carboplatin will be given concurrently with radiation therapy weekly (+/- 1 day).
- RadiationProton Radiation Therapy
Chemoradiation with proton or photon radiation therapy concurrent with weekly Paclitaxel and Carboplatin for 5 weeks
Locations (3)
- Massachusetts General HospitalBoston, Massachusetts
- Beth-Israel Deaconess Medical CenterBoston, Massachusetts
- Massachusetts General Hospital at Newton Wellesley HospitalNewton, Massachusetts