Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT04656041

Folfox+Irinotecan+Chemort In Esophageal Cancer

Led by Massachusetts General Hospital · Updated on 2025-11-14

40

Participants Needed

3

Research Sites

335 weeks

Total Duration

On this page

Sponsors

M

Massachusetts General Hospital

Lead Sponsor

I

Ipsen

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Folfox+Irinotecan+Chemort In Esophageal Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically or cytologically confirmed T3/4 or N+ gastroesophageal junction or esophagogastric cancer
  • Age 18 years or older with no upper age limit
  • ECOG performance status of 0 or 1
  • Life expectancy greater than 3 months
  • Adequate organ and marrow function including neutrophils, platelets, bilirubin, liver enzymes, and kidney function
  • Agreement to use effective contraception during and for 30 days after study treatment if of childbearing potential
  • Negative pregnancy test for females of childbearing potential
  • Ability to understand and willingness to sign informed consent
Not Eligible

You will not qualify if you...

  • Evidence of metastatic disease outside the radiation area
  • Previous chemotherapy, targeted therapy, or radiation for esophagogastric cancer
  • Treatment of other invasive cancers with high recurrence risk within past 5 years
  • Use of any investigational agents within 4 weeks before study start
  • Serious systemic disorders such as significant cardiac or pulmonary disease or recent heart attack
  • History of uncontrolled seizures, CNS disorders, or psychiatric disability affecting consent or compliance
  • Pregnant or breastfeeding women
  • Major surgery within 4 weeks before study start without full recovery
  • Concurrent use of cimetidine
  • Known uncontrolled bleeding disorders
  • Prior systemic fluoropyrimidine therapy within 6 months unless adjuvant
  • Known allergy to 5-fluorouracil, irinotecan, oxaliplatin, or related compounds

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Massachusetts General Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

2

Beth-Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Not Yet Recruiting

3

Massachusetts General Hospital at Newton Wellesley Hospital

Newton, Massachusetts, United States, 02462

Actively Recruiting

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Research Team

J

Jennifer Wo, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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