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Study on the Safety of Using Chemoradiation with Cisplatin and Carboplatin for Early-Stage Vulvar Cancer Patients with Macrometastasis in Sentinel Lymph Node

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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 vulvar cancer, a type of cancer that affects the external female genitalia. The trial is investigating the safety of using a combination of chemotherapy and radiation therapy, known as chemoradiation, as a treatment for early-stage vulvar cancer. The study aims to see if chemoradiation can safely replace a more invasive surgical procedure called inguinofemoral lymphadenectomy, which involves removing lymph nodes in the groin area. This approach is being tested in patients who have a macrometastasis, which means a cancer spread larger than 2mm, in the sentinel lymph node, a key lymph node that cancer cells are likely to spread to first.

The trial involves the use of two chemotherapy drugs: cisplatin and carboplatin. These drugs are given as a solution through an intravenous (IV) infusion, which means they are delivered directly into the bloodstream through a vein. The study will observe patients over a period to monitor the safety and effectiveness of this treatment approach. The main goal is to see if this method can prevent the recurrence of cancer in the groin area, while also looking at other factors such as treatment-related side effects, survival specific to the disease, and the quality of life reported by patients.

The trial is expected to continue until March 2029, with the recruitment of participants having started in July 2019. By participating in this study, researchers hope to gather important information that could lead to less invasive treatment options for patients with early-stage vulvar cancer, potentially improving their overall treatment experience and outcomes.

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, eligibility is confirmed based on specific criteria such as age, health status, and the characteristics of the vulvar cancer.

    Informed consent is obtained, ensuring understanding of the study requirements and procedures.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the current health status and confirm the presence of a macrometastasis in the sentinel lymph node.

    This assessment may include imaging tests such as CT, MRI, or ultrasound to ensure no enlarged or suspicious lymph nodes are present.

  3. Step 3

    Treatment phase

    The treatment involves chemoradiation as an alternative to surgical removal of lymph nodes.

    Medications used include cisplatin and carboplatin, both administered as a solution for infusion through an IV.

    The dosage and frequency of these medications are determined by the healthcare provider based on individual patient needs.

  4. Step 4

    Monitoring and follow-up

    Regular follow-up appointments are scheduled to monitor the response to treatment and check for any side effects.

    The primary focus is on detecting any groin recurrences and assessing treatment-related side effects.

  5. Step 5

    Evaluation of outcomes

    The study aims to evaluate the safety and effectiveness of the treatment by measuring outcomes such as disease-specific survival and quality of life.

    Patient-reported outcomes are collected to assess the impact of treatment on daily life and well-being.

Who can join the trial?

10 criteria

  • Must have a confirmed diagnosis of primary **squamous cell carcinoma** of the vulva. This is a type of skin cancer that affects the vulva.
  • Must have a **performance status** of 0, 1, or 2 on the **ECOG Scale**. This scale measures how well a person can perform daily activities. A lower number means better ability.
  • Must be 18 years or older.
  • Must have a life expectancy of more than 12 weeks.
  • Must have a single **T1 tumor** with a diameter of less than 4 cm. This refers to a small tumor size.
  • Must not have enlarged or suspicious **inguinofemoral lymph nodes** on imaging tests like CT, MRI, or ultrasound. These are lymph nodes in the groin area.
  • Must be able to give **informed consent**, meaning they understand the study and agree to participate.
  • Must have a **metastatic sentinel lymph node** with a metastasis size greater than 2mm, or more than one sentinel node with a metastasis of 2mm or less. This refers to cancer spread to specific lymph nodes.
  • Must be able to understand the study requirements and follow the study and follow-up procedures.
  • Must have adequate **bone marrow**, **renal** (kidney), and **liver function**. This means these organs are working well enough.

Who cannot join the trial?

5 criteria

  • Patients who do not have **vulvar cancer** cannot participate. Vulvar cancer is a type of cancer that affects the external female genital organs.
  • Patients who are not female cannot participate.
  • Patients who are not within the specified age range cannot participate. The age range is typically defined by the study, but it is not specified here.
  • Patients who do not have a **macrometastasis** in the **sentinel lymph node** cannot participate. A macrometastasis is a cancer spread larger than 2mm, and the sentinel lymph node is the first lymph node to which cancer cells are most likely to spread from a primary tumor.
  • Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups like children, pregnant women, or those unable to give consent.
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Investigated drugs

  • Inguinofemoral Lymphadenectomy

    is a surgical procedure that involves the removal of lymph nodes in the groin area. This is typically done to prevent the spread of cancer. In this trial, the procedure is being compared to other treatments to see if it can be safely replaced.

  • Chemoradiation

    is a combination of chemotherapy and radiation therapy. Chemotherapy uses drugs to kill cancer cells or stop them from growing, while radiation therapy uses high-energy rays to target and destroy cancer cells. In this trial, chemoradiation is being tested as a standalone treatment for early-stage vulvar cancer patients with a specific type of lymph node involvement.

What is already known about the treatment

  • Radiation Therapy

    This treatment is administered externally, using high-energy rays to target and destroy cancer cells. It is currently a well-established method in medical practice and literature, particularly for various types of cancer, including vulvar cancer. The main therapeutic indication for radiation therapy in this trial is to treat early-stage vulvar cancer with macrometastasis in the sentinel lymph node. At the molecular level, radiation damages the DNA of cancer cells, preventing them from growing and dividing. It is classified as a form of cancer treatment that uses ionizing radiation to kill or control malignant cells.

  • Chemotherapy

    This treatment is typically administered intravenously or orally, using drugs to kill cancer cells or stop them from growing. In medical literature, chemotherapy is a widely recognized treatment for many cancers, including vulvar cancer. The main therapeutic indication in this trial is to replace more invasive surgical procedures in early-stage vulvar cancer patients with macrometastasis in the sentinel lymph node. Chemotherapy works at the molecular level by interfering with the cancer cell's ability to divide and grow. It is classified as a systemic treatment that targets rapidly dividing cells throughout the body.

Investigated diseases

Vulvar cancer – Vulvar cancer is a type of cancer that occurs on the outer surface area of the female genitalia. It often begins as a lump or sore on the vulva that may cause itching or discomfort. As the disease progresses, it can spread to nearby tissues and lymph nodes, particularly the inguinofemoral lymph nodes. The cancer may cause changes in the skin color or texture of the vulva, and in some cases, it can lead to bleeding or pain. Early-stage vulvar cancer may be limited to the vulva, but if not treated, it can advance to other parts of the body. The progression of the disease can vary, with some cases remaining localized while others may spread more extensively.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-508722-99-00Estimated enrolment132 patientsSponsorUniversitair Medisch Centrum Groningen

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