Perioperative FLOT vs Adjuvant XELOX for CA Stomach

Q: Who can participate in NCT05264896?

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.

Q: How do I contact the trial site for NCT05264896?

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.

Q: 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.

Q: 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.

Perioperative FLOT Versus Adjuvant XELOX for Locally Advanced Gastric Cancer - a Randomized Controlled Study

Perioperative FLOT vs Adjuvant XELOX for CA Stomach (NCT05264896) is a Phase 3 interventional studying Cancer of Stomach, Adenocarcinoma, sponsored by Chinese University of Hong Kong. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

This is a single centre randomised controlled trial, comparing perioperative FLOT versus adjuvant XELOX for locally advanced gastric and esophagogastric junction cancers. Patients with operable clinical T3 or above and N1 or above gastric and esophagastric junction cancer would be recruited. Participants would be randomised to perioperative FLOT versus adjuvant XELOX with curative radical gastrectomy. Primary outcome would be 3 year Disease Free Survival. It was calculated that 110 patients would be required to demonstrate the study hypothesis.

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Cancer of Stomach, Adenocarcinoma, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory 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.

Target enrollment of 110 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Cancer of Stomach, Adenocarcinoma subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Locally advanced adenocarcinoma of stomach or esophagogastric junction (Siewert type II and III), defined by clinical stage ≥T3 and/or ≥N1, in the absence of distant metastasis 2. Surgically resectable disease based on clinical staging 3. No previous gastrectomy or chemotherapy 4. Age 18 or above but less than 80, and 5. ECOG ≤2 6. Hemoglobin \>/= 8.0 g/dL 7. Neutrophils \>/= 1.500/µl 8. platelet count at least 100.000/µl 9. kidney function (creatinine clearance) at least 50 ml/min 10. Serum albumin \>25 g/L Who Should NOT Join This Trial: 1. Distant metastases, direct tumor invasion to organs not resectable by surgery 2. Hypersensitivity or contraindication against Capacitabine, 5-FU, Leucovorin, Oxaliplatin, Docetaxel 3. Active CHD, Cardiomyopathy or cardiac insufficiency stage III-IV according to NYHA 4. Peripheral polyneuropathy ≥ NCI grade II 5. Severe liver dysfunction (i) ALT \>3 x upper limit of normal, and/ or (ii) total bilirubin \>1.5 x upper limit of normal (subjects with Gilbert Syndrome with total bilirubin level of \>/= 3.0 x upper limit of normal) 6. Pregnancy or lactation 7. Malignant secondary disease, dated back \<5 years (except in-situ carcinoma of cervix uteri, adequately treated skin basal cell carcinoma) 8. Serious uncontrolled infection or cocomitant severe medical conditions 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: 1. Locally advanced adenocarcinoma of stomach or esophagogastric junction (Siewert type II and III), defined by clinical stage ≥T3 and/or ≥N1, in the absence of distant metastasis 2. Surgically resectable disease based on clinical staging 3. No previous gastrectomy or chemotherapy 4. Age 18 or above but less than 80, and 5. ECOG ≤2 6. Hemoglobin \>/= 8.0 g/dL 7. Neutrophils \>/= 1.500/µl 8. Platelets ≥ 100.000/µl 9. Creatinine clearance ≥ 50 ml/min 10. Serum albumin \>25 g/L Exclusion criteria: 1. Distant metastases, direct tumor invasion to organs not resectable by surgery 2. Hypersensitivity or contraindication against Capacitabine, 5-FU, Leucovorin, Oxaliplatin, Docetaxel 3. Active CHD, Cardiomyopathy or cardiac insufficiency stage III-IV according to NYHA 4. Peripheral polyneuropathy ≥ NCI grade II 5. Severe liver dysfunction (i) ALT \>3 x upper limit of normal, and/ or (ii) total bilirubin \>1.5 x upper limit of normal (subjects with Gilbert Syndrome with total bilirubin level of \>/= 3.0 x upper limit of normal) 6. Pregnancy or lactation 7. Malignant secondary disease, dated back \<5 years (except in-situ carcinoma of cervix uteri, adequately treated skin basal cell carcinoma) 8. Serious uncontrolled infection or cocomitant severe medical conditions

Treatments Being Tested

DRUG

5-FU, Leucovorin, Oxaliplatin, Docetaxel

FLOT 4 cycles pre and post radical gastrectomy

DRUG

XELOX

XELOX 8 cycles post radical gastrectomy

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.

The Chinese University of Hong Kong

Hong Kong, Hong Kong

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05264896), the sponsor (Chinese University of Hong Kong), 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 NCT05264896 clinical trial studying?

Who can participate in NCT05264896?

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 NCT05264896?

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 NCT05264896. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05264896. 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.