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

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What is this study about?

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.

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 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 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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Clinico San Carlos	Madrid	Spain
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Academisch Ziekenhuis Leiden	Leiden	The Netherlands
Catharina Ziekenhuis Stichting	Eindhoven	The Netherlands
Fakultni Nemocnice Kralovske Vinohrady	Prague	Czechia
Netherlands Cancer Institute	Amsterdam	The Netherlands
Aluleidta Ujl	Amsterdam	The Netherlands
Siznkbyic Rcrbjrn Ufrcitivnz Meivoqq Chpgsm	Nijmegen	The Netherlands
Ugqsjziwtoto Mtrfguw Cansros Gxcdnccer	Groningen	The Netherlands

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	01.07.2023
Czechia	Recruiting	01.07.2023
Spain	Not yet recruiting	01.07.2023
The Netherlands	Recruiting	01.07.2023

Trial locations

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.

Investigated diseases:

Vulval cancer

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 ID:

2022-502685-25-00

Trial Phase:

Therapeutic use (Phase IV)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?