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Study of Capecitabine for Patients with Recurrent or Metastatic Salivary Duct 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 a type of cancer known as Salivary Duct Carcinoma, which affects the salivary glands. The trial is investigating the effects of a medication called Capecitabine. This medication is taken orally and is being tested to see how well it works for patients with this specific type of cancer that has either returned or spread to other parts of the body.

The purpose of the study is to evaluate the overall response rate to Capecitabine in treating recurrent or metastatic salivary duct carcinoma. Participants in the study will receive the medication over a period of time, and researchers will monitor their response to the treatment. The study aims to gather information on how the cancer responds to the medication, how long patients can live without the disease getting worse, and the overall survival rate. Additionally, the study will assess the safety of the medication and its impact on the quality of life of the participants.

Throughout the study, researchers will collect data to understand the clinical benefits and control of the disease provided by Capecitabine. The trial is expected to continue until the end of 2029, with recruitment of participants starting in early 2025. This research is important for finding new ways to manage and treat salivary duct carcinoma, especially for those whose cancer has not responded to other treatments.

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 assessment

    Upon joining the trial, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of recurrent or metastatic salivary duct carcinoma.

    The assessment ensures adequate kidney, liver, and bone marrow function. Blood tests are performed to check these functions.

    Eligibility also requires progression on certain therapies or being unfit for them, and the presence of measurable disease or bone metastases.

  2. Step 2

    Consent and documentation

    Written informed consent is required to participate in the trial. This document outlines the trial's purpose, procedures, and potential risks and benefits.

    Participants must be at least 18 years old and have an ECOG performance status of 0-1, indicating full activity or some symptoms but nearly fully ambulatory.

  3. Step 3

    Treatment phase

    The treatment involves taking capecitabine orally. The specific dosage and frequency are determined by the trial protocol and the participant's health status.

    Capecitabine is a medication used to treat certain types of cancer by interfering with the growth of cancer cells.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring is conducted to assess the response to treatment. This includes imaging tests and clinical evaluations.

    Participants are monitored for any side effects or adverse reactions to the medication.

  5. Step 5

    Evaluation of outcomes

    The primary outcome measured is the best overall response rate, which evaluates how well the cancer responds to the treatment.

    Secondary outcomes include progression-free survival, overall survival, clinical benefit rate, disease control rate, safety, and quality of life.

  6. Step 6

    Completion and final assessment

    The trial is estimated to end by December 31, 2029. A final assessment is conducted to evaluate the overall outcomes and any long-term effects of the treatment.

Who can join the trial?

11 criteria

  • Must have a confirmed diagnosis of **Salivary Duct Carcinoma** that cannot be cured.
  • Must have **adequate kidney function**, which means the kidneys are working well enough. This is checked by measuring a substance in the blood called **serum creatinine**. It should be no more than 1.5 times the normal level, or the kidneys should clear at least 30 milliliters per minute.
  • Must provide **written informed consent**, which means agreeing to participate after understanding the study details.
  • If the cancer is **AR+ HER2-**, the patient must have shown disease progression despite treatment or be unwilling to receive a treatment called **androgen blockade**.
  • If the cancer is **AR+ HER2+**, the patient must have shown disease progression despite treatment with **anti-HER2 therapy** and androgen blockade, or be unwilling to receive androgen blockade.
  • Must have shown disease progression after treatment with **carboplatin-paclitaxel** or be unable to receive this treatment.
  • Must have a disease that can be measured according to specific guidelines (RECIST v1.1) or have only bone metastases that do not meet these guidelines.
  • Must be **18 years or older**.
  • Must have an **ECOG performance status** of 0-1, which means being fully active or having some symptoms but still able to carry out light work.
  • Must have **adequate bone marrow function**, which means having enough healthy blood cells. This is checked by measuring **neutrophils** (a type of white blood cell), **platelets** (cells that help with blood clotting), and **hemoglobin** (a protein in red blood cells).
  • Must have **adequate liver function**, which means the liver is working well enough. This is checked by measuring substances in the blood like **total bilirubin** and liver enzymes called **ALT** and **AST**. Different levels are allowed for patients with a condition called **Gilbert’s Syndrome** or those with liver metastases.

Who cannot join the trial?

3 criteria

  • Patients with a different type of cancer than Salivary Duct Carcinoma cannot participate. This is a specific type of cancer that affects the salivary glands.
  • Individuals who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
  • Participants who are part of a vulnerable population are not eligible. A vulnerable population includes groups like children, pregnant women, or those unable to give consent.
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Investigated drugs

Capecitabine is a medication used in this trial to treat patients with recurrent or metastatic salivary duct carcinoma. It is a type of chemotherapy that works by interfering with the growth of cancer cells, slowing their spread in the body. Capecitabine is often used when other treatments have not been successful, and it is taken orally in the form of a pill. The goal of using capecitabine in this trial is to evaluate its effectiveness in improving the overall response rate in patients with this type of cancer.

What is already known about the treatment

Capecitabine – Capecitabine is an oral medication, taken by mouth in the form of tablets. It is currently being studied in clinical trials for its effectiveness in treating recurrent and/or metastatic salivary duct carcinoma. This medication is primarily used in the treatment of certain types of cancer, including breast and colorectal cancers. Capecitabine works by interfering with the DNA production in cancer cells, which prevents them from growing and dividing. It belongs to a class of drugs known as antimetabolites, which are designed to target and disrupt the growth of cancer cells.

Investigated diseases

Salivary Duct Carcinoma – This is a rare type of cancer that originates in the ducts of the salivary glands. It typically presents as a rapidly growing mass in the mouth or neck area. The disease can cause symptoms such as pain, swelling, and difficulty swallowing. As it progresses, it may invade nearby tissues and potentially spread to other parts of the body. Salivary duct carcinoma is known for its aggressive nature and tendency to recur after treatment. It is more commonly diagnosed in older adults and is often associated with a poor prognosis.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-516956-16-01Protocol code116162Estimated enrolment17 patientsSponsorStichting Radboud universitair medisch centrum

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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.

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