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Study comparing chemotherapy with or without radiation therapy in patients with resectable gastroesophageal junction cancer using docetaxel, oxaliplatin, fluorouracil and calcium folinate

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

This study focuses on treating adenocarcinoma of the gastroesophageal junction, which is cancer occurring where the esophagus (food pipe) meets the stomach. The treatment involves a combination of chemotherapy medications including fluorouracil, docetaxel, oxaliplatin, and calcium folinate, which are given through an intravenous line directly into the bloodstream.

The purpose of this research is to determine if adding radiation therapy to chemotherapy before surgery works better than using chemotherapy alone before and after surgery for treating this type of cancer. The study compares these two different approaches to find out which one is more effective at preventing the cancer from returning.

Patients who participate in the study will receive treatment for approximately 33 weeks. During this time, they will receive either chemotherapy alone or chemotherapy combined with radiation therapy, followed by surgery to remove the cancer. After surgery, doctors will monitor the patients' progress to see how well the treatment worked and check for any side effects.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial evaluation

    Your doctor will confirm the presence of adenocarcinoma of the gastroesophageal junction (cancer where the esophagus meets the stomach) through tissue examination

    Medical tests will check your blood counts, liver function, kidney function, and heart rhythm to ensure you can safely participate in the treatment

  2. Step 2

    Treatment assignment

    You will be randomly assigned to one of two treatment groups

    Both groups will receive chemotherapy, but one group will also receive radiation therapy

  3. Step 3

    Treatment period

    You will receive treatment with four medications through an intravenous line (directly into your vein):

    - Fluorouracil

    - Docetaxel

    - Oxaliplatin

    - Calcium folinate

    If you are in the radiation therapy group, you will receive this treatment alongside chemotherapy

  4. Step 4

    Surgery

    After completing the initial treatment, you will undergo surgery to remove the tumor

    The surgery will include removal of lymph nodes to check for cancer spread

  5. Step 5

    Follow-up period

    Regular check-ups will monitor your recovery and track any cancer progression

    You will complete quality of life questionnaires during this period

    The study will continue until June 2025

  6. Step 6

    Safety considerations

    Side effects will be monitored and recorded throughout the treatment

    You must use effective birth control during treatment and for 6 months afterward

    Regular blood tests will monitor your health throughout the study

Who can join the trial?

12 criteria

  • Have a confirmed diagnosis of gastroesophageal junction cancer (a type of cancer where the esophagus meets the stomach) that is locally advanced but potentially removable by surgery
  • Be considered suitable for curative surgery as determined by the surgeon
  • Have an ECOG performance status of 0-1 (able to carry out all or most daily activities)
  • Be 18 years or older

  • Have adequate blood cell counts:

    • Neutrophils (white blood cells) ≥ 1.5 x 109/l
    • Platelets ≥ 100 x 109/l
    • Hemoglobin (red blood cell protein) ≥ 9.0 mg/dl
  • Have normal blood clotting function tests within 7 days before starting the study
  • Have adequate liver function with liver enzyme levels no more than 2.5 times the normal limit
  • Have adequate kidney function with creatinine levels no more than 1.5 times the normal limit
  • Have a normal heart rhythm measurement (QTc interval ≤ 440 ms)
  • Provide written informed consent before joining the study
  • For women who can become pregnant: have a negative pregnancy test within 7 days before starting treatment
  • Both men and women must agree to use effective birth control during the study and for 6 months after treatment ends

Who cannot join the trial?

14 criteria

  • Age under 18 or over 75 years old
  • Inability to undergo surgery due to medical conditions
  • Previous cancer treatment for gastroesophageal junction adenocarcinoma
  • Presence of distant metastases (cancer spread to distant organs)
  • Significant heart conditions that would interfere with treatment
  • Severe kidney or liver dysfunction
  • Pregnancy or breastfeeding
  • Active infectious diseases including hepatitis B, hepatitis C, or HIV
  • Other types of cancer within the last 5 years
  • Mental conditions that would prevent understanding of the trial requirements
  • Inability to follow study procedures or attend follow-up visits
  • Contraindications (medical reasons not to use) to chemotherapy or radiation therapy
  • Participation in other clinical trials within the last 30 days
  • Allergies to study medications
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Investigated drugs

Based on the provided trial information, which involves radiochemotherapy and chemotherapy for gastroesophageal junction adenocarcinoma, the treatments involved are: Chemotherapy - A treatment that uses powerful drugs to kill cancer cells or stop them from growing and dividing. This treatment is given to patients both before and after surgery (perioperative) to target cancer cells throughout the body. Radiochemotherapy - A combined treatment approach that uses both radiation therapy and chemotherapy together. The radiation therapy uses high-energy rays to target and kill cancer cells in specific areas, while chemotherapy drugs work throughout the body. This combination is given before surgery (neoadjuvant) to help shrink the tumor and make it easier to remove.

What is already known about the treatment

  • Fluorouracil

    Fluorouracil is given by an intravenous (IV) drip, usually over several minutes. It is an established cancer drug that has been used for many years and is well described in medical literature. It is mainly used to treat cancers of the stomach, colon, breast and head‑neck, including adenocarcinoma of the gastro‑esophageal junction. It works by mimicking a building block of DNA, stopping cancer cells from making DNA and thus preventing them from growing; it belongs to the antimetabolite class of chemotherapy agents.

  • Docetaxel

    Docetaxel is administered through an IV infusion, typically over an hour. It is a widely accepted chemotherapy medicine with a long record of use in clinical practice. It is mainly used for breast, lung, prostate and gastric cancers, and is part of the treatment regimen for gastro‑esophageal junction adenocarcinoma. It works by binding to tiny structures inside cells called microtubules, forcing them to stay rigid and stopping cancer cells from dividing; it is classified as a taxane chemotherapy.

  • Oxaliplatin

    Oxaliplatin is also given by IV infusion, usually over a short period. It is a standard chemotherapy drug that has been studied extensively and is approved for use in many countries. It is mainly used for colorectal cancer and is included in combination regimens for stomach and gastro‑esophageal junction cancers. It damages the DNA of cancer cells by forming cross‑links, which blocks the cells from copying their genetic material; it belongs to the platinum‑based chemotherapy group.

  • Calcium Folinate

    Calcium folinate is delivered intravenously, often right after fluorouracil. It is a well‑known supportive medication that is routinely used in oncology to reduce side effects. It is mainly used to lessen the toxic effects of fluorouracil and other similar drugs during cancer treatment. It works by providing a form of folate that helps normal cells repair DNA and reduces damage, and it is classified as a folinic acid rescue agent.

Investigated diseases

Adenocarcinoma of the gastroesophageal junction - A cancer that develops at the area where the esophagus meets the stomach. The disease begins when cells in the gastroesophageal junction start growing uncontrollably, forming a tumor that originates in the glandular tissue. It typically starts in the inner layer of the junction tissue and can grow outward through other layers. The condition is classified into three types (I-III) based on the exact location of the tumor in relation to the junction between the esophagus and stomach. As the disease progresses, the tumor can grow larger and potentially spread to nearby lymph nodes and tissues.
Trial detailsLast updated 21 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516271-32-00Protocol codeRACEEstimated enrolment342 patientsSponsorHeidelberg University

sourced from the EU Clinical Trials Register and site verification

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