Not yet recruiting

Capecitabine drug combination in perioperative treatment for patients with gastric and esophageal cancer

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on two types of upper‑digestive tract cancer, Gastric Cancer and Esophageal cancer. Both are cancers that start in the lining of the stomach or the tube that connects the throat to the stomach. The treatment being tested replaces the traditional chemotherapy drug 5‑fluorouracil with an oral medication called capecitabine, which is taken as film‑coated tablets. The medication is given around the time of surgery – before the operation to shrink the tumor (called neoadjuvant therapy) and after the operation to eliminate any remaining cancer cells (called adjuvant therapy).

The purpose of the study is to find the highest dose of capecitabine that can be given safely together with the other drugs in the FLOT regimen for patients with these cancers. Participants will start with a low dose of the tablets and the dose will be increased step by step in small groups of patients until side effects become too frequent, which helps researchers identify the maximum tolerated dose.

During the study, patients will have regular check‑ups to monitor any side effects and to see how well the drug is processed in the body. Blood samples will be taken to measure the amount of drug and its breakdown products, and any complications after surgery will be recorded. The information gathered will help determine the safest and most effective dose for future treatment plans.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Join the study
After giving informed consent, you become a participant in the trial and receive a schedule of visits and treatments.
Step 2
Baseline assessments
Initial medical examinations, blood tests, and imaging are performed to confirm eligibility and to record your health status before treatment begins.
Step 3
Start preoperative (neoadjuvant) treatment
You begin taking capecitabine tablets by mouth. the total daily dose is calculated as 1300 mg per square meter of body surface area (bsa). the dose is usually split into two equal doses taken each day.
The tablets are available in 500 mg and 150 mg strengths; the number of tablets is adjusted to reach the prescribed total dose based on your bsa.
This oral medication is taken for a defined number of cycles as specified in the study protocol, typically lasting several weeks before surgery.
Step 4
Continue preoperative cycles
You repeat the capecitabine dosing schedule for each cycle, attending regular clinic visits for safety monitoring and blood work.
Any side effects are recorded and managed according to the study guidelines.
Step 5
Surgery
After completing the planned preoperative cycles, you undergo surgical removal of the tumor as part of standard care.
The trial medication is paused during the postoperative recovery period.
Step 6
Start postoperative (adjuvant) treatment
Once you have recovered sufficiently from surgery, you resume oral capecitabine using the same dose calculation (1300 mg/m² per day) and schedule as before.
The medication is given for a series of postoperative cycles, as defined by the study protocol.
Step 7
Post‑treatment follow‑up
After completing all treatment cycles, you attend follow‑up visits for clinical assessment, imaging, and laboratory tests to evaluate the outcome of the therapy.

Who can join the trial?

5 criteria

You have a diagnosis of esophageal, gastro‑esophageal junction (GEJ) or gastric cancer that has been histologically confirmed (a doctor looked at a small piece of the tumor under a microscope to be sure).
Your doctor plans to give you the perioperative FLOT chemotherapy (a specific mix of four chemotherapy medicines given before and after surgery; “perioperative” means around the time of surgery).
Your overall health level, measured by the WHO performance score, must be 0 or 1 (a scale where 0 means fully active and 1 means able to work but with some restrictions).
You must be at least 18 years old.
You must sign a written informed consent form that follows ICH‑GCP guidelines (international rules that protect patients in clinical studies; “written informed consent” means you read and understand the study information and agree in writing to take part).

Who cannot join the trial?

8 criteria

Having any of the routinely tested DPYD gene variants that affect how the body processes the chemotherapy medication.
Having any condition that makes the planned FLOT chemotherapy regimen unsafe, such as an active infection, a serious other illness, a strong allergy, or nerve damage.
Having blood or organ test results that show inadequate function, including very low hemoglobin (blood’s oxygen‑carrying protein), low white‑blood‑cell count (neutrophils), low platelet count, poor kidney function (creatinine clearance), or poor liver function (high bilirubin or high liver enzymes).
Being pregnant or breastfeeding (pregnant or lactating women).
Being enrolled in another clinical study that could affect the results of this study.
Being unwilling or unable to follow the study rules and visits (study protocol).
Being unable to swallow the medication because of severe swallowing problems (dysphagia grade 3 or higher).
Being unable to receive the full dose of the chemotherapy drugs capecitabine or 5‑FU due to kidney problems or other medical reasons that make the full dose unsafe.

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Verified sites

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Responsive
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Rotterdam, The Netherlands

Trial locations

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Investigated drugs

Capecitabine is an oral chemotherapy medicine that is taken by mouth in the form of film‑coated tablets. In this study it is being used to replace the traditional intravenous drug 5‑fluorouracil (5‑FU) as part of the perioperative treatment plan for patients with cancer of the esophagus, gastro‑esophageal junction, or stomach. By giving capecitabine before and after surgery, researchers hope to find a safe dose that works well while being more convenient for patients, since the drug can be taken at home instead of needing an IV infusion.

Capecitabine

What is already known about the treatment

Capecitabine 500 mg film-coated tablets
Capecitabine 500 mg film‑coated tablets are taken by mouth as a swallowable tablet. The drug is an approved chemotherapy medicine that has been studied extensively in cancer treatment. It is mainly used to treat gastric and esophageal cancers, often as part of combination regimens. Capecitabine works by being changed inside the body into 5‑fluorouracil, which blocks the building of DNA in cancer cells, and it belongs to the antimetabolite class of fluoropyrimidine drugs.
Capecitabine 150 mg film-coated tablets
Capecitabine 150 mg film‑coated tablets are also taken orally as a swallowable tablet. This medication is an approved cancer drug with a long record in medical literature. It is used primarily for gastric and esophageal cancers, usually together with other chemotherapy agents. After swallowing, the tablet is converted to 5‑fluorouracil, which interferes with DNA production in tumor cells, and it is classified as an antimetabolite fluoropyrimidine.

Investigated diseases

Gastric cancer
A type of cancer that starts in the lining of the stomach. It often begins as small abnormal cells that grow slowly and may appear as ulcers or thickened areas. Over time the cells can spread deeper into the stomach wall and reach nearby lymph nodes. The disease can also extend to other organs if it continues to grow. It may develop gradually, sometimes without noticeable signs early on.
Esophageal cancer
A cancer that originates in the tube connecting the throat to the stomach. It usually starts as abnormal cells in the inner lining that form a small tumor. The tumor can grow outward, narrowing the passage and making swallowing difficult. As it expands, it can invade surrounding tissues and spread to nearby lymph nodes. The condition may progress slowly at first but can become more extensive over time.