NCT04656041 Folfox+Irinotecan+Chemort In Esophageal Cancer
| NCT ID | NCT04656041 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Massachusetts General Hospital |
| Condition | Gastroesophageal Junction Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2021-06-29 |
| Primary Completion | 2024-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 40 participants in total. It began in 2021-06-29 with a primary completion date of 2024-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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.
Contact & Investigator
Jennifer Wo, MD
PRINCIPAL INVESTIGATOR
Massachusetts General Hospital
Frequently Asked Questions
Who can join the NCT04656041 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Gastroesophageal Junction Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04656041 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04656041 currently recruiting?
Yes, NCT04656041 is actively recruiting participants. Contact the research team at JWO@mgh.harvard.edu for enrollment information.
Where is the NCT04656041 trial being conducted?
This trial is being conducted at Boston, United States, Boston, United States, Newton, United States.
Who is sponsoring the NCT04656041 clinical trial?
NCT04656041 is sponsored by Massachusetts General Hospital. The principal investigator is Jennifer Wo, MD at Massachusetts General Hospital. The trial plans to enroll 40 participants.