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Study of drug combination therapy for patients with lymph node-positive esophageal and esophagogastric junction cancer using carboplatin, paclitaxel, fluorouracil, folinic acid, docetaxel and oxaliplatin

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 clinical trial focuses on treating patients with adenocarcinoma of the esophagus and esophagogastric junction. The study aims to evaluate a treatment approach called Total Neoadjuvant Therapy (TNT) in patients whose cancer has spread to nearby lymph nodes but has not spread to other parts of the body.

The treatment involves a combination of several cancer medications administered through intravenous infusion. These medications include fluorouracil, docetaxel, oxaliplatin, carboplatin, paclitaxel, and folinic acid. These drugs work together to kill cancer cells or stop them from growing. The medications will be given in specific sequences and combinations over several weeks.

The study will examine how well patients respond to this treatment by measuring how long they remain free from cancer progression. The treatment plan includes giving these medications before surgery, which is different from traditional approaches where some treatments are given after surgery. This approach aims to potentially improve outcomes for patients with this type of cancer.

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 treatment will begin with medical tests to confirm your eligibility for the trial. This includes blood tests to check bone marrow, kidney, and liver function.

    A heart and lung assessment will be performed if you have any related symptoms.

    For patients 70 years or older, a special health assessment will be conducted.

  2. Step 2

    Treatment Path Assignment

    You will be assigned to receive one of two treatment combinations:

    Option 1: FLOT treatment followed by CROSS treatment

    Option 2: CROSS treatment followed by FLOT treatment

  3. Step 3

    FLOT Treatment

    This treatment consists of 4 cycles of medication given through an intravenous infusion

    The medications include: fluorouracil, oxaliplatin, and docetaxel

    Regular blood tests will monitor your response to treatment

  4. Step 4

    CROSS Treatment

    This treatment includes 5 cycles of chemotherapy given through an intravenous infusion

    The medications used are: carboplatin and paclitaxel

    Treatment will be monitored for any side effects

  5. Step 5

    Response Evaluation

    After completing both treatments, your response will be evaluated through medical imaging

    The medical team will assess if the cancer has responded to the treatment

    Based on the results, further treatment decisions will be made

  6. Step 6

    Follow-up Period

    Regular check-ups will continue for 2 years after treatment completion

    These visits will include medical examinations and quality of life assessments

    Any side effects will continue to be monitored and managed

Who can join the trial?

16 criteria

  • Age 18 or older. For patients aged 70 or above, a special assessment of general health and functioning will be required
  • Diagnosed with adenocarcinoma (a type of cancer) of the esophagus or where the esophagus meets the stomach, that can be surgically removed
  • No previous chemotherapy treatment for esophageal cancer
  • No previous radiation therapy to the chest, abdomen, or neck area that would overlap with the planned treatment area
  • Good overall physical condition (able to carry out all normal activities with minimal restrictions)
  • Weight loss must be less than 10% of body weight
  • Adequate heart and lung function
  • Healthy blood counts, including:
    • White blood cells above 3x109/L
    • Hemoglobin above 5.5 mmol/L
    • Platelets above 100x109/L
    • Good kidney function and liver function tests within acceptable ranges
    • For women who can become pregnant:
      • Negative pregnancy test during screening
      • Must use effective birth control during the study and for 3 months after
      • Cancer growth into the stomach area must not exceed 4 cm when measured by endoscopy
      • Must be able to understand and comply with study procedures
      • Must provide written informed consent to participate

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 75 years
  • Previous treatment with chemotherapy or radiation therapy for esophageal cancer or esophagogastric junction cancer
  • Presence of distant metastases (cancer spread to other parts of the body)
  • Significant heart conditions, including heart failure or recent heart attack (within last 6 months)
  • Severe liver disease or abnormal liver function tests
  • Severe kidney disease or abnormal kidney function tests
  • Active infections requiring treatment
  • Other types of cancer in the past 5 years (except adequately treated non-melanoma skin cancer)
  • Pregnancy or breastfeeding
  • Mental conditions that could interfere with following study procedures
  • Known allergies to study medications
  • Participation in other clinical trials within the past 30 days
  • Unable to swallow oral medications
  • Peripheral neuropathy (nerve damage causing numbness or tingling in hands and feet) grade 2 or higher
  • Inability to provide informed consent
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Investigated drugs

FLOT is a combination chemotherapy treatment that includes fluorouracil, leucovorin, oxaliplatin, and docetaxel. This treatment is used to fight esophageal cancer and cancer at the junction between the esophagus and stomach. CROSS is a combined treatment approach that includes chemotherapy with carboplatin and paclitaxel along with radiation therapy. This treatment is designed to shrink tumors in the esophagus and surrounding areas before surgery. Note: Both treatments are used as neoadjuvant therapy, which means they are given before the main cancer surgery to help shrink the tumor and improve surgical outcomes.

What is already known about the treatment

  • FLOT

    A combination chemotherapy regimen consisting of fluorouracil, leucovorin, oxaliplatin, and docetaxel, administered intravenously for the treatment of esophageal and gastroesophageal junction cancers. This medication protocol is primarily used as neoadjuvant therapy (treatment before surgery) to shrink tumors and improve surgical outcomes. The drugs in this combination work together by interfering with cancer cell division and DNA replication, effectively stopping tumor growth and promoting cancer cell death.

  • CROSS

    A combined chemoradiotherapy regimen consisting of carboplatin and paclitaxel given concurrently with radiation therapy, used in the treatment of esophageal and gastroesophageal junction cancers. This treatment protocol is administered intravenously along with targeted radiation therapy, working through multiple mechanisms to damage cancer cell DNA and prevent tumor cell division. The combination of chemotherapy and radiation therapy in this regimen has shown significant effectiveness in treating these types of cancers before surgery.

Investigated diseases

  • Esophageal Cancer

    A disease that develops in the tissues of the esophagus, the muscular tube that connects the throat to the stomach. It typically begins in the cells that line the inside of the esophagus. The disease can develop gradually, starting with changes in the esophageal cells. As it progresses, it can affect the deeper layers of the esophageal wall.

  • Esophagogastric Junction Cancer

    A cancer that forms at the area where the esophagus meets the stomach. This type of cancer develops in the cells at this specific junction point. The disease affects the lower portion of the esophagus and the upper portion of the stomach. It can spread through the layers of tissue at the junction area as it progresses.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-521158-40-00Protocol codeTNT-OES-2Estimated enrolment216 patientsSponsorErasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

sourced from the EU Clinical Trials Register and site verification

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