New combo therapy shows promise for Tough-to-Treat stomach cancer
NCT ID NCT03279237
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This pilot study tested a combination of chemotherapy drugs (FOLFIRINOX plus paclitaxel and carboplatin) along with proton beam radiation before surgery in 25 people with gastroesophageal cancer. The goal was to see if this intense pre-surgery treatment could shrink tumors and be completed safely. The study is complete, but results on how well it worked are still being analyzed.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- FOLFIRINOX (a combination of 5-fluorouracil, oxaliplatin, irinotecan, and leucovorin) plus paclitaxel, carboplatin, and proton beam radiation
- What this could lead to
- If successful, this approach could improve tumor shrinkage before surgery for gastroesophageal cancer, potentially leading to better outcomes.
- What could go wrong
- This is a small, early-phase pilot study (Phase 1) with only 25 participants, so results may not apply broadly. The combination of multiple drugs and radiation may cause significant side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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25 people
The number who actually took part.
- Started
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Oct 2017
- Finished
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Apr 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Massachusetts General Hospital
Boston, Massachusetts, 02214, United States
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