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Study Comparing Chemoradiation and Chemotherapy with Cisplatin, Paclitaxel, and Carboplatin for Patients with Advanced Vulvar Cancer

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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 the treatment of locally advanced vulvar carcinoma, a type of cancer that affects the external female genital organs. The study aims to compare two treatment strategies: primary chemoradiation and neoadjuvant chemotherapy followed by surgery. Chemoradiation combines chemotherapy and radiation therapy to target cancer cells, while neoadjuvant chemotherapy involves administering chemotherapy before surgery to shrink the tumor.

The medications being used in this study include cisplatin, paclitaxel, and carboplatin. These are chemotherapy drugs that help stop the growth of cancer cells. Cisplatin and carboplatin are given through an intravenous infusion, which means they are administered directly into the bloodstream through a vein. Paclitaxel is also given in the same way. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the actual drugs.

The purpose of the study is to evaluate the effectiveness and safety of these treatment strategies in patients with locally advanced vulvar carcinoma. Participants will undergo treatment over a period of several months, with regular monitoring to assess their response to the treatment and any side effects. The study will also look at factors such as quality of life, organ preservation, and the influence of HPV status on treatment outcomes. The trial is expected to continue until 2029, with the goal of improving treatment options for this type of cancer.

The research process

The trial runs in 8 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, you will be informed about the trial's purpose, procedures, and potential risks and benefits. You will be required to provide a signed and written informed consent to participate.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm eligibility. This includes verifying your age, medical history, and current health status. Tests will be performed to ensure adequate blood, liver, and kidney function.

  3. Step 3

    Treatment allocation

    You will be assigned to one of two treatment groups: primary chemoradiation or neoadjuvant chemotherapy followed by surgery. The assignment is based on the study's design and is not influenced by personal preference.

  4. Step 4

    Chemotherapy administration

    If assigned to the chemotherapy group, you will receive medications such as cisplatin, paclitaxel, or carboplatin through an intravenous infusion. The specific dosage, frequency, and duration will be determined by the study protocol and your healthcare provider.

  5. Step 5

    Radiation therapy

    If you are in the chemoradiation group, you will undergo radiation therapy sessions. The schedule and duration of these sessions will be explained to you by the medical team.

  6. Step 6

    Surgery

    For those in the neoadjuvant chemotherapy group, surgery will follow the chemotherapy treatment. The type and extent of surgery will depend on the response to chemotherapy and the specific characteristics of your condition.

  7. Step 7

    Follow-up assessments

    Regular follow-up assessments will be conducted to monitor your health and the effectiveness of the treatment. These assessments may include physical exams, imaging tests, and laboratory tests.

  8. Step 8

    End of study

    The study will conclude after a specified period, and you will be informed about the overall results and any further steps if necessary. Your participation will contribute to understanding the treatment's efficacy and safety.

Who can join the trial?

10 criteria

  • Women aged 18 years or older
  • For women who can have children, a Beta HCG level of 14 mIU/mL or below is required. Beta HCG is a hormone measured to check for pregnancy.
  • Use of highly effective birth control if there is a chance of becoming pregnant
  • Signed and written informed consent, meaning you agree to participate after understanding the study
  • Diagnosis of primary or recurrent squamous cell carcinoma vulvar cancer at FIGO stage Ib to IVa, T1b or higher, any N, M0. This is a type of skin cancer affecting the vulva, classified by its size and spread.
  • A local tumor that requires treatment with primary chemoradiation or extensive surgery. This includes tumors that are T1b or larger with groin metastases (cancer spread to groin lymph nodes) or tumors close to or involving the urethra or anal sphincter.
  • World Health Organization performance status of 0-2, which measures your ability to perform daily activities
  • Adequate hematological function, meaning your blood health is good, with a platelet count over 100x10E9/L, absolute neutrophil count over 1.5x10E9/L, and hemoglobin over 6.0 mmol/L
  • Adequate hepatic function, meaning your liver is working well, with a total bilirubin level 1.5 times the upper limit of normal or less, and ASAT and ALAT levels 2.5 times the upper limit of normal or less
  • Adequate renal function, meaning your kidneys are working well, with an estimated creatinine clearance of 50 mL/min or more, calculated using the Cockroft-Gault formula or a similar method

Who cannot join the trial?

4 criteria

  • Patients who are not diagnosed with LAVC (locally advanced vulvar cancer).
  • Patients who do not require primary chemoradiation or extensive surgery that affects pelvic organs.
  • Patients who are not female, as the study is only for female participants.
  • Patients who are considered part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

  • Cisplatin

    is a medication used in this trial as part of the chemoradiation treatment. It is a type of chemotherapy that works by stopping the growth of cancer cells. Cisplatin is often used in combination with radiation therapy to enhance the effectiveness of the treatment against cancer.

  • Paclitaxel

    is another chemotherapy drug used in this trial. It helps to stop cancer cells from dividing and growing. Paclitaxel is used in the neoadjuvant chemotherapy phase, which means it is given before surgery to shrink the tumor and make it easier to remove.

What is already known about the treatment

  • Primary Chemoradiation

    This treatment involves a combination of chemotherapy and radiation therapy, administered to patients with locally advanced vulvar carcinoma (LAVC) who require significant intervention. The current status of this treatment in medical literature is as a standard approach for managing LAVC, especially when surgery might cause extensive damage to pelvic organs. The main therapeutic indication is to treat LAVC effectively while preserving as much normal tissue function as possible. At the molecular level, chemoradiation works by damaging the DNA of cancer cells, preventing them from growing and dividing. It is classified pharmacologically as a combination therapy involving both chemical and radiation components.

  • Neoadjuvant Chemotherapy

    This treatment involves administering chemotherapy before surgery to shrink tumors in patients with locally advanced vulvar carcinoma (LAVC). It is currently being studied in clinical trials to determine its effectiveness compared to primary chemoradiation. The main therapeutic indication is to reduce tumor size before surgical removal, potentially allowing for less extensive surgery. At the molecular level, neoadjuvant chemotherapy targets rapidly dividing cancer cells, disrupting their growth and replication. It is classified as a systemic chemotherapy treatment.

Investigated diseases

Locally Advanced Cervical Cancer – Locally advanced cervical cancer refers to cancer that has spread beyond the cervix to nearby tissues but not to distant parts of the body. It typically involves the parametria, the pelvic sidewall, or the lower third of the vagina. The progression of this disease can lead to symptoms such as pelvic pain, abnormal vaginal bleeding, and urinary or bowel issues. As the cancer advances, it may invade surrounding organs, including the bladder or rectum. The disease can also cause swelling in the legs due to lymphatic obstruction. Management often involves a combination of treatments to control the spread and alleviate symptoms.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2022-502685-25-00Estimated enrolment98 patientsSponsorHet Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

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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).