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Gastroesophageal Junction AdenocarcinomaPhase 2NCT04656041

Folfox+Irinotecan+Chemort In Esophageal Cancer

A Phase 2 study testing FOLFOX/ nal-IRI, Paclitaxel and Carboplatin in people with Gastroesophageal Junction Adenocarcinoma and Esophagogastric Cancer, run by Massachusetts General Hospital at 3 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
FOLFOX/ nal-IRI, Paclitaxel and Carboplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
3 sitesUnited States
Study dates
29 Jun 2021to Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jennifer Wo, MD contact

(617) 726-6050

JWO@mgh.harvard.edu

United States3 sites, 3 recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02115

    Jennifer Wo, MD, 617-726-6050, JWO@mgh.harvard.edu

    Jennifer Wo, MD

    Recruiting

  • Beth-Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

    Andrea Bullock, MD, (617) 667-2100, abullock@bidmc.harvard.edu

    Andrea Bullock, MD

    Not yet recruiting

  • Massachusetts General Hospital at Newton Wellesley Hospital

    Newton, Massachusetts, 02462

    Lawrence Blaszkowsky, MD, (617) 219-1230, lblaszkowsky@partners.org

    Lawrence Blaszkowsky, MD

    Recruiting

Other trials in United States

About this study

Official title: A Phase II Study of Neoadjuvant NAPOX Followed by Chemoradiation With Paclitaxel and Carboplatin in Locally Advanced Esophagogastric Cancer

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
Read the detailed description

The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.

This research study involves the following standard of care interventions:

  • FOLFOX (leucovorin calcium, 5-Fluorouracil, and oxaliplatin)
  • Carboplatin
  • Paclitaxel
  • Radiation therapy

This research study involves the following study intervention:

  • Liposomal irinotecan

It is expected that about 40 people will take part in this research study.

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied. The U.S. Food and Drug Administration (FDA) has not approved liposomal irinotecan for your specific disease but it has been approved for other uses. The FDA has approved FOLFOX, carboplatin, and paclitaxel as treatment options for this disease.

Being tested
FOLFOX/ nal-IRI, Paclitaxel, Carboplatin, Proton Radiation Therapy
Keywords
Gastroesophageal Junction Adenocarcinoma, Esophagogastric cancer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FOLFOX/ nal-IRIDrug

    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

  • PaclitaxelDrug

    Also called Abraxane®.

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

  • CarboplatinDrug

    Also called Paraplatin

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

  • Proton Radiation TherapyRadiation

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

Study groups in NCT04656041
Study groupRoleWhat they receive
FOLFOX/ nal-IRIExperimentalTreatment 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
Receives: Drug: FOLFOX/ nal-IRI; Drug: Paclitaxel; Drug: Carboplatin; Radiation: Proton Radiation Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 38 Weeks

Secondary outcomes (6)

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

    Toxicity associated with neoadjuvant FOLFOX/ nal-IRI and chemoradiation will be summarized by category and grade according to the CTCAE version 5.0 Acute and late toxicities will be scored using Common Toxicity Criteria (CTCAE) version 5.

    Toxicities will be noted and recorded in protocol-specific case reports from the time of first dose of protocol therapy until 5 years after the end of protocol therapy

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

  2. Clinical Response

    The rate of objective clinical response to induction FOLFOX/ nal-IRI and chemoradiation will be reported as the proportion of eligible patients starting protocol therapy who achieve a complete or partial response as the best overall response

    Measured: 8 Weeks

  3. Clinical Response

    The rate of objective clinical response to induction FOLFOX/ nal-IRI and chemoradiation will be reported as the proportion of eligible patients starting protocol therapy who achieve a complete or partial response as the best overall response

    Measured: 16 Weeks

  4. Clinical Response

    The rate of objective clinical response to induction FOLFOX/ nal-IRI and chemoradiation will be reported as the proportion of eligible patients starting protocol therapy who achieve a complete or partial response as the best overall response

    Measured: 25 Weeks

  5. Progression-Free Survival (PFS)

    Progression-free survival (PFS) is defined as the duration from the first date of protocol therapy to the earliest date of disease progression per RECIST criteria or death due to any cause. PFS time will be censored at the date of last follow-up for patients still alive with no documentation of progressive disease. The PFS rate will be estimated using the Kaplan-Meier method with 95% confidence intervals based on the complementary log-log transformation.

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

  6. Overall Survival

    Overall survival (OS) is defined as the duration from the first date of protocol therapy to the date of death due to any cause and will be censored at the date of last follow-up for patients still alive. The OS rate will be estimated using the Kaplan-Meier method with 95% confidence intervals based on the complementary log-log transformation

    Measured: first date of protocol therapy to the date of death due to any cause and will be censored at the date of last follow-up for patients still alive up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Dec 2020
  2. Study start29 Jun 2021
  3. Primary completion30 Apr 2024
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04656041
Sponsor's protocol ID
20-452
Status last verified
Nov 2025
First submitted
30 Nov 2020
Last updated
14 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FOLFOX/ nal-IRI, Paclitaxel and Carboplatin in people with Gastroesophageal Junction Adenocarcinoma and Esophagogastric Cancer, run by Massachusetts General Hospital at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jennifer Wo, MD ((617) 726-6050, JWO@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathologic Complete Response Rate (time frame: 38 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04656041.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2025.

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