Folfox+Irinotecan+Chemort In Esophageal Cancer

NCT04656041 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 20-452
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Gastroesophageal Junction Adenocarcinoma; Esophagogastric cancer

Outcome Measures

Primary Outcomes (1)

• Pathologic Complete Response Rate

  All patients will undergo a full pathological review of their surgical specimen according to the AJCC Staging Classification, 6th. Initial gross evaluation and identification of resection margins will be performed jointly by the surgeon and the pathologist. Pathological complete response will be defined as the absence of any viable tumor cells within the pathologic specimen.

  38 Weeks

Secondary Outcomes (6)

• Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v5.0

  first dose of protocol therapy until 5 years after the end of protocol therapy

• Clinical Response

  8 Weeks

• Clinical Response

  16 Weeks

• Clinical Response

  25 Weeks

• Progression-Free Survival (PFS)

  duration from the first date of protocol therapy to the earliest date of disease progression up 5 years

Study Arms (1)

FOLFOX/ nal-IRI

EXPERIMENTAL

Treatment will be administered on an outpatient basis. * FOLFOX with nal-IRI for eight two-week cycles (16 weeks total) * Chemoradiation with proton or photon radiation therapy concurrent with weekly Paclitaxel and Carboplatin for 5 weeks * Surgery

Drug: FOLFOX/ nal-IRI; Drug: Paclitaxel; Drug: Carboplatin; Radiation: Proton Radiation Therapy

Interventions

FOLFOX/ nal-IRI DRUG

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

FOLFOX/ nal-IRI

Paclitaxel DRUG

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

Also known as: Abraxane®.

FOLFOX/ nal-IRI

Carboplatin DRUG

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

Also known as: Paraplatin

FOLFOX/ nal-IRI

Proton Radiation Therapy RADIATION

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

FOLFOX/ nal-IRI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 upper limit of normal OR two down trending values.
• AST(SGOT) ≤ 2.5 x upper limit of normal
• ALT (SGPT) ≤ 2.5 x upper limit of normal
• creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 30 mL/min/1.73 m2 for participants with creatinine levels above institutional normal.
• The effects of both radiation therapy and the chemotherapy agents used in this trial are known to be teratogenic. Therefore, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation plus 30 days from the last date of study drug administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
• Female subject of childbearing potential should have a negative urine or serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Participants who fulfill any of the following criteria will be excluded from the study:
• Evidence of metastatic disease as determined by chest CT scan, abdomen/pelvis CT scan (or MRI with gadolinium and/or manganese) within six weeks of study entry. Distant nodal disease is allowed if it is in the radiation port.
• Any prior chemotherapy, targeted/biologic therapy, or radiation for treatment of the participant's esophagogastric cancer.
• Treatment of other invasive carcinomas within the last five years with greater than 5% risk of recurrence at time of eligibility screening. Carcinoma in-situ and basal cell carcinoma/ squamous cell carcinoma of the skin are allowed.
• Receipt of any other investigational agents within 4 weeks preceding the start of study treatment.
• Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator), such as significant cardiac or pulmonary morbidity (e.g.congestive heart failure, symptomatic coronary artery disease and/or cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months, or ongoing infection as manifested by fever.
• History of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance or drug intake.
• Pregnant women are excluded from this study because radiation therapy and the chemotherapy agents to be used have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with these agents, breastfeeding should be discontinued while the mother is receiving protocol therapy.
• Major surgery, excluding laparoscopy, within 4 weeks of the start of study treatment, without complete recovery.
• No concurrent administration of cimetidine (as it can decrease the clearance of 5-FU). Another H2-blocker or proton pump inhibitor may be substituted before study entry.
• Known, existing uncontrolled coagulopathy.
• Prior systemic fluoropyrimidine therapy (unless given in an adjuvant setting and at least six months earlier). Prior topical fluoropyrimidine use is allowed.
• Known hypersensitivity to 5-fluorouracil or known DPD deficiency.
• History of allergic reaction(s) attributed to compounds of similar chemical or biologic composition to 5-fluorouracil, irinotecan, or oxaliplatin.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Ipsen: collaborator

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Beth-Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

NOT YET RECRUITING

Massachusetts General Hospital at Newton Wellesley Hospital

Newton, Massachusetts, 02462, United States

RECRUITING

MeSH Terms

Interventions

Folfox protocol; irinotecan sucrosofate; Paclitaxel; Albumin-Bound Paclitaxel; Carboplatin; Protons

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Coordination Complexes; Cations, Monovalent; Cations; Ions; Electrolytes; Inorganic Chemicals; Hydrogen; Elements; Gases; Nucleons; Elementary Particles; Physical Phenomena

Study Officials

• Jennifer Wo, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Wo, MD

CONTACT

(617) 726-6050; JWO@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: December 7, 2020
• Study Start: June 29, 2021
• Primary Completion: April 30, 2024
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 14, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation

Locations

US (3)