NCT05264896RecruitingPhase 3
Perioperative FLOT vs Adjuvant XELOX for CA Stomach
Perioperative FLOT Versus Adjuvant XELOX for Locally Advanced Gastric Cancer - a Randomized Controlled Study
Source: ClinicalTrials.gov · Last updated 7 Sept 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 110 (estimated)
- First submitted
- 22 Feb 2022
- Start date
- 21 Mar 2022
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- Chinese University of Hong Kong
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT05264896
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 110
- From 21 Mar 2022 to the primary completion date, 31 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Distant metastases, direct tumor invasion to organs not resectable by surgery
Other illness
- Hypersensitivity or contraindication against Capacitabine, 5-FU, Leucovorin, Oxaliplatin, Docetaxel
- Active CHD, Cardiomyopathy or cardiac insufficiency stage III-IV according to NYHA
- Serious uncontrolled infection or cocomitant severe medical conditions
Lab values
- 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)
Age
- Malignant secondary disease, dated back \<5 years (except in-situ carcinoma of cervix uteri, adequately treated skin basal cell carcinoma)
Other
- Peripheral polyneuropathy ≥ NCI grade II
- Pregnancy or lactation
Who the study is looking for
- 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
- Surgically resectable disease based on clinical staging
- No previous gastrectomy or chemotherapy
- Age 18 or above but less than 80, and
- ECOG ≤2
- Hemoglobin \>/= 8.0 g/dL
- Neutrophils \>/= 1.500/µl
- Platelets ≥ 100.000/µl
- Creatinine clearance ≥ 50 ml/min
- Serum albumin \>25 g/L
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Chinese University of Hong Kong Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.