Neoadjuvant FOLFIRINOX in the Treatment of Locally Advanced Gastric Cancer

Neoadjuvant FOLFIRINOX in the Treatment of Locally Advanced Gastric Cancer (NCT03825861) is a Phase 2 interventional studying Gastric Cancer, sponsored by Instituto do Cancer do Estado de São Paulo. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

Phase II single-arm study designed to evaluate the efficacy and safety of preoperative chemotherapy with FOLFIRINOX regimen. The investigators will include 27 patients with resectable locally advanced gastric cancer. They will receive preoperative chemotherapy with FOLFIRINOX regimen by long-term catheter every 14 days for 8 cycles accounting for a total of 4 months of systemic treatment. In the period between 4 and 8 weeks of the last cycle, restaging tests will be performed and if there is no metastatic progression of disease, the patient will undergo surgical treatment with curative intention. The objective is to evaluate whether preoperative treatment with FOLFIRINOX regimen involving continuous infusion and bolus infusion of 5-fluoruracil, irinotecan bolus and oxaliplatin bolus is effective and safe in the neoadjuvant treatment of locally advanced gastric cancer. The planned recruitment period is 48 months (4 years). There will be a total of 4 months of preoperative chemotherapy. In case of limiting toxicity or disease progression, chemotherapy will be suspended and patients may undergo resection of the primary neoplasia at the discretion of the surgical team of the institution. Patients will be followed for 5 years after entry of the last participant in the protocol for OS and PFS evaluation. The end of the study will occur when the last participant completes their last follow-up visit, which should occur no later than 60 months after enrollment in the study.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Gastric Cancer and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 27 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - Histological diagnosis of gastric adenocarcinoma that is amenable to surgical resection at diagnosis, with locally advanced disease criteria for clinical evaluation (T3 tumors, T4 tumors and / or regional lymph node involvement). - Absence of metastatic disease at a distance (computerized tomography, diagnostic laparoscopy and peritoneal lavage). - Age 18-75 years. - Clinical functionality by the ECOG scale between 0 and 1. - Preserved renal function (creatinine clearance greater than 50 mL / min). - Signature of willing to sign a consent form Form Who Should NOT Join This Trial: - Active neoplasm of another primary site other than non-melanoma skin carcinoma. - Lesions of the esophagogastric transition - Unresectable lesions by computed tomography and / or diagnostic laparoscopy. - Obstructive tumors (acute intestinal occlusion or subocclusion). - Tumors with signs of significant or persistent bleeding. - Carcinoma in situ. - Different histological type of adenocarcinoma. - Gastric stump tumors. - Previous chemotherapeutic or radiotherapy treatment. - Current pregnancy or breastfeeding. - Total bilirubin above 1.5mg / dL. - Hepatic transaminases greater than 1.5 times the upper limit of normality. - Decompensated and / or symptomatic cardiomyopathy: congestive heart failure with functional class greater than 2 by the New York Heart Association; active coronary disease; uncontrolled cardiac arrhythmia; history of acute myocardial infarction in the last 6 months. - Psychological, familial, social or even geographical condition that potentially hinders adherence to the study protocol and the pre-established follow-up. - Current or previous psychiatric or neurological diagnosis that is decompensated, compromises the cognition, functionality or adherence to the proposed treatment. - Other comorbidities that are decompensated at the time of treatment. - Pregnant or breastfeeding women. Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Histological diagnosis of gastric adenocarcinoma that is amenable to surgical resection at diagnosis, with locally advanced disease criteria for clinical evaluation (T3 tumors, T4 tumors and / or regional lymph node involvement). * Absence of metastatic disease at a distance (computerized tomography, diagnostic laparoscopy and peritoneal lavage). * Age 18-75 years. * Clinical functionality by the ECOG scale between 0 and 1. * Preserved renal function (creatinine clearance greater than 50 mL / min). * Signature of Informed Consent Form Exclusion Criteria: * Active neoplasm of another primary site other than non-melanoma skin carcinoma. * Lesions of the esophagogastric transition * Unresectable lesions by computed tomography and / or diagnostic laparoscopy. * Obstructive tumors (acute intestinal occlusion or subocclusion). * Tumors with signs of significant or persistent bleeding. * Carcinoma in situ. * Different histological type of adenocarcinoma. * Gastric stump tumors. * Previous chemotherapeutic or radiotherapy treatment. * Current pregnancy or breastfeeding. * Total bilirubin above 1.5mg / dL. * Hepatic transaminases greater than 1.5 times the upper limit of normality. * Decompensated and / or symptomatic cardiomyopathy: congestive heart failure with functional class greater than 2 by the New York Heart Association; active coronary disease; uncontrolled cardiac arrhythmia; history of acute myocardial infarction in the last 6 months. * Psychological, familial, social or even geographical condition that potentially hinders adherence to the study protocol and the pre-established follow-up. * Current or previous psychiatric or neurological diagnosis that is decompensated, compromises the cognition, functionality or adherence to the proposed treatment. * Other comorbidities that are decompensated at the time of treatment. * Pregnant or breastfeeding women.

Treatments Being Tested

DRUG

FOLFIRINOX

Oxaliplatin 85mg/m2, Leucovorin 200mg/m2, Irinotecan 180mg/m2, 5-FU 400mg/m2 bolus followed by 2400mg/m2 continuous infusion.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Instituto do Câncer do Estado de São Paulo

São Paulo, Brazil

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT03825861), the sponsor (Instituto do Cancer do Estado de São Paulo), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT03825861 clinical trial studying?

Who can participate in NCT03825861?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT03825861?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT03825861. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT03825861. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.