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

NCT03279237 | Completed Phase 1 Results DMC FDA Drug

• 2 other identifiers: 17-311U19CA021239-37
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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 Radiation Therapy

Conditions

GastroEsophageal Cancer

Keywords

GastroEsophageal Cancer

Outcome Measures

Primary Outcomes (1)

• The Completion Rate of Chemotherapy in Combination With Chemoradiation

  The number of participants that complete the assigned study intervention.

  21 weeks

Secondary Outcomes (5)

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

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

• Clinical Response Rate

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

• Pathologic Complete Response Rate

  29 Weeks

• Progression Free Survival

  5 Years

• Overall Survival

  5 Years

Study Arms (1)

FOLFIRINOX + pre-operative radiation

EXPERIMENTAL

* 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

Drug: Irinotecan; Drug: Oxaliplatin; Drug: Leucovorin; Drug: 5-Fluorouracil; Drug: Paclitaxel; Radiation: Radiation Therapy; Drug: Carboplatin

Interventions

Irinotecan DRUG

May help shrink tumor before surgery.

Also known as: Camptosar

FOLFIRINOX + pre-operative radiation

Oxaliplatin DRUG

May help shrink tumor before surgery.

Also known as: Eloxatin

FOLFIRINOX + pre-operative radiation

Leucovorin DRUG

May help shrink tumor before surgery.

FOLFIRINOX + pre-operative radiation

5-Fluorouracil DRUG

May help shrink tumor before surgery.

Also known as: Efudex

FOLFIRINOX + pre-operative radiation

Paclitaxel DRUG

Paclitaxel may stop cancer cells from growing and spreading.

Also known as: Abraxane

FOLFIRINOX + pre-operative radiation

Radiation Therapy RADIATION

May help shrink tumor.

FOLFIRINOX + pre-operative radiation

Carboplatin DRUG

Carboplatin may stop cancer cells from growing.

FOLFIRINOX + pre-operative radiation

Eligibility Criteria

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

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.
• 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
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02214, United States

Location

Related Publications (1)

• 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.

  PMID: 34330715 DERIVED

MeSH Terms

Interventions

Irinotecan; Oxaliplatin; Leucovorin; Fluorouracil; Paclitaxel; Albumin-Bound Paclitaxel; Radiotherapy; Carboplatin

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Coordination Complexes; Organic Chemicals; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Therapeutics

Results Point of Contact

• Title: Dr. Theodore Hong
• Organization: Massachusetts General Hospital

TSHONG1@mgh.harvard.edu

(617) 726-2000

Study Officials

• Jennifer Wo, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• 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: September 7, 2017
• First Posted: September 12, 2017
• Study Start: October 24, 2017
• Primary Completion: September 26, 2018
• Study Completion: February 29, 2024
• Last Updated: November 25, 2025
• Results First Posted: May 7, 2020

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)