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GastroEsophageal CancerPhase 1NCT03279237

A Pilot Study of FOLFIRINOX in Combination With Neoadjuvant Radiation for Gastric and GE Junction Cancers

A Phase 1 study testing Irinotecan, Oxaliplatin and Leucovorin in people with GastroEsophageal Cancer, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This research study is studying a combination of interventions as a possible treatment for gastroesophageal (GE) junction cancer. The interventions involved in this study are: -FOLFIRINOX which is made up of 4 different drugs: 5-Fluorouracil (5-FU) Oxaliplatin Irinotecan Leucovorin Paclitaxel Carboplatin Proton Beam… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
GastroEsophageal Cancer
What is being tested?
Irinotecan, Oxaliplatin and Leucovorin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteUnited States
Study dates
24 Oct 2017to 1 Apr 2026
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Histologically or cytologically confirmed T 3/4 or N+ (> 1 cm in size or FDG avid) gastric or gastroesophageal (GE) junction cancer. Diagnosis must be confirmed by the Mass General Hospital pathology department.
  • 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
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  • 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 or two down trending values.
  • AST(SGOT) ≤ 2.5 × 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.
  • Ability to understand and the willingness to sign a written informed consent document

Who cannot join

  • 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 gastric or GE junction cancer.
  • Receipt of chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
  • 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

1 site in 1 country.

United States1 site

  • Massachusetts General Hospital

    Boston, Massachusetts, 02214

Other trials in United States

About this study

This research study is studying a combination of interventions as a possible treatment for gastroesophageal (GE) junction cancer.

The interventions involved in this study are:

-FOLFIRINOX which is made up of 4 different drugs:

  • 5-Fluorouracil (5-FU)
  • Oxaliplatin
  • Irinotecan
  • Leucovorin
  • Paclitaxel
  • Carboplatin
  • Proton Beam Radiation Therapy
Read the detailed description

This research study is a Pilot Study, which is the first time investigators are examining this study intervention.

In this research study, the investigators are studying the combination of FOLFIRINOX followed by radiation with paclitaxel and carboplatin before surgery. The investigators believe that this intervention may help decrease the growth and spread of the cancer cells.

FOLFIRINOX has shown to be very effective in patients whom disease has spread. The investigators are evaluating this regimen to see if there is an increase in curability when the cancer has not spread.

The FDA (the U.S. Food and Drug Administration) has approved FOLFIRINOX as a treatment option for this disease.

The FDA has not approved Paclitaxel or Carboplatin for this specific disease but they have both been approved for other uses.

FOLFIRINOX is a combination of 4 chemotherapy agents that may help shrink the tumor before surgery.

Carboplatin may stop the cancer cells from growing and paclitaxel may stop the cancer cells from growing and spreading

Being tested
Irinotecan, Oxaliplatin, Leucovorin, 5-Fluorouracil, Paclitaxel
Keywords
GastroEsophageal Cancer

What participants receive

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

  • IrinotecanDrug

    Also called Camptosar

    May help shrink tumor before surgery.

  • OxaliplatinDrug

    Also called Eloxatin

    May help shrink tumor before surgery.

  • LeucovorinDrug

    May help shrink tumor before surgery.

  • 5-FluorouracilDrug

    Also called Efudex

    May help shrink tumor before surgery.

  • PaclitaxelDrug

    Also called Abraxane

    Paclitaxel may stop cancer cells from growing and spreading.

  • Radiation TherapyRadiation

    May help shrink tumor.

  • CarboplatinDrug

    Carboplatin may stop cancer cells from growing.

Study groups in NCT03279237
Study groupRoleWhat they receive
FOLFIRINOX + pre-operative radiationExperimental* FOLFIRINOX is a combination of 4 drugs that is administered twice per cycle * Oxaliplatin is administered intravenously * Leucovorin is administered intravenously * Irinotecan is administered intravenously * 5-Fluorouracil is administered intravenously * Paclitaxel and Carboplatin will be given concurrently with radiation therapy every 7 days
Receives: Drug: Irinotecan; Drug: Oxaliplatin; Drug: Leucovorin; Drug: 5-Fluorouracil; Drug: Paclitaxel; Radiation: Radiation Therapy; Drug: Carboplatin

What is being measured

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

  1. The Completion Rate of Chemotherapy in Combination With Chemoradiation

    The number of participants that complete the assigned study intervention.

    Measured: 21 weeks

Secondary outcomes (5)

  1. Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0

    The number of participants that experienced at least one treatment related adverse event as assessed by Common Terminology Criteria for Adverse Events (CTCAE v4.0).

    Measured: From the start of treatment until 30 days after the end of treatment (up to approximately 25 weeks)

  2. Clinical Response Rate

    The number of participants that achieved a clinical response following treatment. Clinical response is defined as achieving a best overall response of a complete response (CR) or a partial response (PR).

    • Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
    • Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

    Measured: After 4 and 8 cycles of FOLFIRINOX (8 and 16 weeks); and 3-4 weeks after chemo radiation (24-25 weeks)

  3. Pathologic Complete Response Rate

    The number of participants that achieve a pathologic complete response at surgery following FOLFIRINOX and chemoradiation. All patients will undergo a full pathological review of their surgical specimen according to the American Joint Committee on Cancer (AJCC) Staging Classification, 6th edition. 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: 29 Weeks

  4. Progression Free Survival

    Progression-free survival (PFS) is defined as the time from the date of first dosing to the first documentation of radiographic disease progression per Response Evaluation Criteria In Solid Tumors (RECIST v1.1) or death due to any cause, whichever occurs first. Subjects who are alive with no documented progressive disease by the data cutoff date for PFS analysis will be censored at the date of their last evaluable disease assessment.

    Progressive Disease (PD) is defined as having at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).

    Measured: 5 Years

  5. Overall Survival

    The number of participants alive five years after the start of treatment. Overall survival (OS) is measured as the time from the date of first dosing until death due to any cause. If there is no death reported for a subject by the data cut-off date for overall survival analysis, OS will be censored at the last known alive date.

    Measured: 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 posted12 Sep 2017
  2. Study start24 Oct 2017
  3. Primary completion26 Sep 2018
  4. Study completion1 Apr 2026

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03279237
Sponsor's protocol ID
17-311
Other IDs
U19CA021239-37
Status last verified
Apr 2026
First submitted
7 Sep 2017
Last updated
18 May 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wo JY, Clark JW, Eyler CE, Mino-Kenudson M, Klempner SJ, Allen JN, Keane FK, Parikh AR, Roeland E, Drapek LC, Ryan DP, Corcoran RB, Van Seventer E, Fetter IJ, Shahzade HA, Khandekar MJ, Lanuti M, Morse CR, Heist RS, Ulysse CA, Christopher B, Baglini C, Yeap BY, Mullen JT, Hong TS. Results and Molecular Correlates from a Pilot Study of Neoadjuvant Induction FOLFIRINOX Followed by Chemoradiation and Surgery for Gastroesophageal Adenocarcinomas. Clin Cancer Res. 2021 Dec 1;27(23):6343-6353. doi: 10.1158/1078-0432.CCR-21-0331. Epub 2021 Jul 30.

    PubMed 34330715

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Irinotecan, Oxaliplatin and Leucovorin in people with GastroEsophageal Cancer, run by Massachusetts General Hospital at 1 site 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: finished, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Completion Rate of Chemotherapy in Combination With Chemoradiation (time frame: 21 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 NCT03279237, which also lists 1 linked publication.

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 18 May 2026.

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