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Folfox+Irinotecan+Chemort In Esophageal Cancer

NCT04656041 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-11-14

No results posted yet for this study

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

Conditions

  • Gastroesophageal Junction Adenocarcinoma
  • Esophagogastric Cancer

Interventions

DRUG

FOLFOX/ 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

DRUG

Paclitaxel

Paclitaxel and Carboplatin will be given concurrently with radiation therapy weekly (+/- 1 day).

DRUG

Carboplatin

Paclitaxel and Carboplatin will be given concurrently with radiation therapy weekly (+/- 1 day).

RADIATION

Proton Radiation Therapy

Chemoradiation with proton or photon radiation therapy concurrent with weekly Paclitaxel and Carboplatin for 5 weeks

Sponsors & Collaborators

  • Ipsen

    collaborator INDUSTRY

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Jennifer Wo, MD · Massachusetts General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-29
Primary Completion
2024-04-30
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04656041 on ClinicalTrials.gov