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Study Comparing Chemoradiotherapy with Fluorouracil, Cisplatin, and Carboplatin for Patients with Operable Esophageal Squamous Cell Carcinoma

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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 esophageal squamous cell carcinoma, a type of cancer that occurs in the esophagus. The study compares two treatment approaches: one involves using a combination of chemotherapy and radiation therapy before surgery, known as neoadjuvant chemoradiotherapy, and the other involves using chemotherapy and radiation therapy as the main treatment, with surgery only if needed, known as definitive chemoradiotherapy. The goal is to determine if the second approach is as effective as the first in terms of overall survival.

The medications used in this study include Fluorouracil, Cisplatin, Carboplatin, Paclitaxel, Folinic Acid (also known as Leucovorin), and Oxaliplatin. These drugs are administered through an intravenous infusion, which means they are given directly into a vein. The study will monitor patients over a period of time to assess their overall survival, quality of life, and any side effects from the treatments.

Participants in the study will receive one of the two treatment plans and will be followed for several years to track their health outcomes. The study aims to provide valuable information on the effectiveness and safety of these treatment strategies for patients with operable, locally advanced esophageal squamous cell carcinoma.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    The trial involves two main treatment strategies for esophageal squamous cell carcinoma. The first strategy is neoadjuvant chemoradiotherapy (nCRT) followed by surgery. The second strategy is definitive chemoradiotherapy (dCRT) with the option of surgery if needed.

    In the nCRT group, patients receive a combination of chemotherapy drugs including fluorouracil, cisplatin, carboplatin, paclitaxel, folinic acid, and oxaliplatin. These medications are administered through an intravenous infusion, which means they are given directly into a vein.

    The specific dosage and frequency of these medications are determined by the medical team based on individual patient needs and the treatment protocol.

  2. Step 2

    Surgery or observation

    For patients in the nCRT group, surgery is performed after the completion of the chemoradiotherapy phase. The goal of the surgery is to remove any remaining cancerous tissue.

    Patients in the dCRT group are monitored closely after the chemoradiotherapy phase. If necessary, surgery may be performed at a later stage if the cancer does not respond adequately to the initial treatment.

  3. Step 3

    Follow-up and monitoring

    After the initial treatment phase, patients enter a follow-up period. This involves regular check-ups to monitor overall health and detect any signs of cancer recurrence.

    The primary focus during this period is on overall survival and health-related quality of life. These are assessed at various intervals, including 6, 12, 24, 36, and 60 months after the start of the trial.

    Additional assessments may include nutritional outcomes, surgical complications, and treatment-related side effects.

Who can join the trial?

10 criteria

  • The patient must have a type of esophageal cancer called squamous cell carcinoma, which is confirmed by a test called histopathology.
  • The cancer should be in a stage where it is considered locally advanced, meaning it has spread nearby but not to distant parts of the body.
  • The cancer must be technically resectable, meaning it can be removed by surgery, as decided by a team of medical experts.
  • The patient should have a performance status of ECOG 0-1, which means they are fully active or have some symptoms but can still do light work.
  • Women who can have children must have a negative pregnancy test before joining the study.
  • Patients who can have children should use a very effective method of birth control during the study and for at least six months after the last treatment.
  • The patient must give written consent to participate, following specific guidelines and regulations.
  • The patient must be between 18 and 80 years old.
  • The patient must have adequate organ function, meaning their organs are working well enough to participate in the study.
  • Women who are breastfeeding should stop nursing before starting the study treatment.

Who cannot join the trial?

10 criteria

  • Patients who have a different type of cancer than the one being studied.
  • Patients who have cancer that cannot be removed by surgery.
  • Patients who have other serious health conditions that could affect their ability to participate in the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who are unable to follow the study procedures for any reason.
  • Patients who have participated in another clinical trial recently.
  • Patients who have allergies to the study medications.
  • Patients who have had a recent heart attack or other serious heart problems.
  • Patients who have an active infection that requires treatment.
  • Patients who have a history of another type of cancer within the last five years, except for certain skin cancers.
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Investigated drugs

  • Neoadjuvant Chemoradiotherapy (nCRT)

    is a treatment approach that combines chemotherapy and radiation therapy before surgery. The goal is to shrink the tumor in the esophagus, making it easier to remove during surgery. This approach is used for patients with esophageal squamous cell carcinoma to improve the chances of successful surgery and potentially enhance survival rates.

  • Definitive Chemoradiotherapy (dCRT)

    is a treatment that combines chemotherapy and radiation therapy as the main treatment without immediate surgery. In this trial, it is used for patients with esophageal squamous cell carcinoma. If the cancer does not respond completely or recurs, surgery may be performed later as a salvage option. This approach aims to control the cancer while avoiding surgery unless absolutely necessary.

What is already known about the treatment

Cisplatin – Cisplatin is administered intravenously and is commonly used in combination with other medications for treating various types of cancer, including esophageal squamous cell carcinoma. It is well-established in medical literature as a chemotherapy agent. The main therapeutic indication for Cisplatin is to treat resectable locally advanced squamous cell carcinoma of the esophagus. At the molecular level, Cisplatin works by binding to DNA in cancer cells, causing cross-linking and ultimately leading to cell death. It is classified as a platinum-based antineoplastic agent.

Investigated diseases

Squamous Cell Carcinoma of the Esophagus – This is a type of cancer that forms in the squamous cells lining the esophagus, the tube that carries food from the throat to the stomach. It is considered locally advanced when it has spread to nearby tissues or lymph nodes but not to distant parts of the body. The disease often begins with difficulty swallowing and may progress to cause weight loss and chest pain. As it advances, it can lead to more severe swallowing problems and may cause a feeling of food being stuck in the throat. The progression of the disease can vary, with some cases remaining stable for a period while others may grow more rapidly.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-500966-82-00Estimated enrolment1 135 patientsSponsorKarolinska University Hospital

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).