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Study on the Effectiveness of Paclitaxel, Docetaxel, and Oxaliplatin in Patients with Resectable Gastric Cancer

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What is this trial about?

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

This clinical trial is focused on studying treatments for gastric cancer, specifically in patients with a type called gastric adenocarcinoma. The study involves several medications, including Paclitaxel (also known as Oncogel or ABI-007), Docetaxel, Oxaliplatin, Capecitabine, and Carboplatin. These medications are used in different combinations to see which treatment plan works best before surgery. The purpose of the study is to find out which treatment plan helps patients live without the cancer coming back for at least one year after starting the treatment.

Participants in the study will receive one of the treatment plans, which may include chemotherapy alone or chemotherapy followed by chemoradiotherapy, before undergoing surgery. Chemotherapy involves using drugs to kill cancer cells, while chemoradiotherapy combines chemotherapy with radiation therapy to target cancer cells more effectively. The medications are given either through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein, or orally, which means they are taken by mouth.

The study will follow participants over a period of time to monitor their health and see how well the treatments work. The main goal is to determine which treatment plan provides the best chance of preventing the cancer from returning or spreading. This information will help doctors make better decisions about how to treat gastric cancer in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will begin treatment within 15 working days after randomization. This is to ensure timely initiation of the treatment process.

  2. Step 2

    Neo-adjuvant chemotherapy

    The patient will receive neo-adjuvant chemotherapy, which involves administering chemotherapy before surgery to shrink the tumor. The medications used in this phase include paclitaxel, docetaxel, oxaliplatin, and carboplatin. These are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

    The specific dosage and frequency of these medications will be determined by the medical team based on individual patient needs and responses.

  3. Step 3

    Surgery

    Following the completion of the neo-adjuvant chemotherapy, the patient will undergo surgery. The goal of the surgery is to remove the tumor from the stomach or gastro-oesophageal junction.

  4. Step 4

    Post-surgery treatment options

    After surgery, the patient may receive additional treatment depending on the specific group they are assigned to in the study. This could include further chemotherapy or chemoradiotherapy, which combines chemotherapy with radiation therapy to target any remaining cancer cells.

  5. Step 5

    Follow-up and monitoring

    The patient will be monitored for event-free survival at 1 year after randomization. This involves checking for any signs of cancer recurrence or progression, as well as monitoring overall health and recovery.

Who can join the trial?

13 criteria

  • Patients must have **gastric cancer** that is classified as stage IB to IIIC according to the TNM 8th edition. The cancer should be in the stomach but can also involve the area where the stomach meets the esophagus.
  • Patients need to start treatment within 15 working days after being randomly assigned to a treatment group.
  • Patients must provide written informed consent, which means they agree to participate after understanding the study details.
  • Patients should be expected to complete the follow-up visits and procedures required by the study.
  • Patients must consume at least 1500 calories per day, as checked by a dietician. If they eat less or have lost significant weight recently, they may need nutritional support.
  • Patients should have a **WHO performance status** of less than 2, which means they are able to carry out all normal activities without assistance.
  • Patients must be 18 years of age or older.
  • The cancer must be **resectable**, meaning it can be surgically removed, and located in the stomach or the gastro-esophageal junction.
  • Patients should not have had any previous radiation treatment to the abdomen.
  • Patients must have certain blood levels: hemoglobin (Hb) of at least 5.0 mmol/L, white blood cells (leukocytes) of at least 3.0x109/L, neutrophils of at least 1.5x109/L, and platelets (thrombocytes) of at least 100x109/L.
  • Patients must have adequate **kidney function**, with serum creatinine levels not more than 1.25 times the upper limit of normal (ULN) and creatinine clearance of at least 50 ml/min.
  • Patients must have adequate **liver function**, with total bilirubin levels not more than 1.5 times the ULN, and alkaline phosphatase and ASAT/ALAT levels not more than 3 times the ULN.
  • During a required procedure called **staging laparoscopy**, any suspicious areas or fluid in the abdomen must be tested and confirmed to not contain cancer cells.
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Investigated drugs

  • Neo-adjuvant Chemotherapy

    is a treatment given before surgery to shrink the tumor in patients with resectable gastric cancer. This approach aims to make the tumor easier to remove and to improve the chances of successful surgery.

  • Neo-adjuvant Chemoradiotherapy

    combines chemotherapy and radiation therapy before surgery. This treatment is designed to reduce the size of the tumor and eliminate any cancer cells that may have spread, increasing the likelihood of a successful surgical outcome.

  • Surgery

    is the procedure to remove the gastric tumor. The goal of surgery is to completely remove the cancerous tissue from the stomach and surrounding areas, which is crucial for the patient's recovery and long-term survival.

What is already known about the treatment

  • Neo-adjuvant Chemotherapy

    This treatment is administered intravenously and is used before surgery to shrink tumors in patients with resectable gastric cancer. It is currently being studied in clinical trials to determine its effectiveness in improving survival rates. The main therapeutic indication is for patients with stage IB-IIC gastric adenocarcinoma. At the molecular level, chemotherapy works by targeting rapidly dividing cancer cells, disrupting their growth and replication. It is classified as an antineoplastic agent.

  • Neo-adjuvant Chemoradiotherapy

    This treatment combines chemotherapy and radiation therapy, administered intravenously and through external radiation, before surgery to treat resectable gastric cancer. It is under investigation in clinical trials to evaluate its impact on survival outcomes. The primary therapeutic use is for patients with stage IB-IIC gastric adenocarcinoma. The mechanism involves chemotherapy targeting cancer cells and radiation damaging their DNA, preventing further growth. It falls under the category of combined modality therapy.

Investigated diseases

Gastric Adenocarcinoma – Gastric adenocarcinoma is a type of cancer that begins in the glandular cells of the stomach lining. It typically progresses through stages, starting from the inner lining and potentially spreading to deeper layers of the stomach wall. As it advances, it may invade nearby organs and lymph nodes. The disease can cause symptoms such as abdominal pain, weight loss, and nausea. In some cases, it may lead to bleeding or obstruction in the stomach. Early detection is crucial for managing its progression effectively.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-503248-15-00Protocol codeM15CRIEstimated enrolment207 patientsSponsorHet Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

sourced from the EU Clinical Trials Register and site verification

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