NCT04656041 · Massachusetts General Hospital
Folfox+Irinotecan+Chemort In Esophageal Cancer
What this study is about
In this research study, is studying how Liposomal Irinotecan in combination with the the usual treatment interventions FOLFOX, carboplatin paclitaxel, and radiation therapy affect gastroesophageal junction or esophagogastric cancer This research study involves the following study intervention: \- Liposomal irinotecan
View original scientific description
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
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
Primary outcome measures
Pathologic Complete Response Rate
Time frame: 38 Weeks
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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:
- 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.
Exclusion criteria
- 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.
Where
- Boston, Massachusetts
- Newton, Massachusetts
Collaborators
Ipsen
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 14, 2025 · Source of record for eligibility and locations