RecruitingPhase 2NCT04656041

Folfox+Irinotecan+Chemort In Esophageal Cancer

A Phase II Study of Neoadjuvant NAPOX Followed by Chemoradiation With Paclitaxel and Carboplatin in Locally Advanced Esophagogastric Cancer


Sponsor

Massachusetts General Hospital

Enrollment

40 participants

Start Date

Jun 29, 2021

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests an intensive chemotherapy combination (FOLFOX, irinotecan, and chemoradiation) before surgery for locally advanced esophageal or gastroesophageal junction cancer that is locally advanced (invading nearby structures or involving lymph nodes). **You may be eligible if...** - You are 18 or older - Your cancer has been confirmed by biopsy (adenocarcinoma or squamous cell carcinoma of the esophagus or GE junction) - Your cancer is locally advanced (T3/T4 or lymph node-positive) - You have an ECOG performance status of 0 or 1 (fully active or minimally restricted) - Your blood counts and organ function are within acceptable ranges **You may NOT be eligible if...** - Your cancer has spread to distant organs (metastatic) - You are pregnant or unwilling to use contraception - Your organ function does not meet the required levels Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 Hospital

Boston, Massachusetts, United States

Beth-Israel Deaconess Medical Center

Boston, Massachusetts, United States

Massachusetts General Hospital at Newton Wellesley Hospital

Newton, Massachusetts, United States

View Full Details on ClinicalTrials.gov

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NCT04656041


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