Study on Fertility Preservation in Women with Stage IB2 Cervical Cancer Using Cisplatin, Carboplatin, and Paclitaxel Before Surgery

2 1 1 1

What is this study about?

This clinical trial is focused on studying cervical cancer, specifically in women with a certain stage of the disease known as FIGO 2018 stage IB2. This stage involves tumors that are larger than 2 cm but not more than 4 cm. The study aims to explore a treatment approach that includes neoadjuvant chemotherapy, which is chemotherapy given before surgery, followed by a type of surgery that aims to preserve fertility, known as fertility-sparing surgery. The chemotherapy drugs being used in this study are cisplatin, carboplatin, and paclitaxel. These medications are administered through an intravenous infusion, which means they are given directly into a vein.

The purpose of the study is to see if it is possible to preserve fertility in women with this type of cervical cancer by using the combination of chemotherapy and surgery, without needing additional treatments afterward. Participants in the study will receive up to three cycles of chemotherapy over a period of up to 12 weeks. After the chemotherapy, if the tumor has shrunk to a certain size, the participants will undergo the fertility-sparing surgery. The study will monitor the participants to determine the success of the treatment in preserving fertility.

This trial is designed to help understand if this treatment approach can be a viable option for women who wish to maintain their ability to have children in the future while effectively treating their cervical cancer. The study will continue to gather information until the end of 2035, providing valuable insights into the effectiveness and safety of this treatment strategy.

1 neoadjuvant chemotherapy

The treatment begins with neoadjuvant chemotherapy, which involves the administration of medications to shrink the tumor before surgery.

The medications used are cisplatin, carboplatin, and paclitaxel. These are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

This phase consists of three cycles of chemotherapy. Each cycle is followed by a period of rest to allow the body to recover.

The goal is to achieve a complete or partial response, meaning the tumor should reduce in size to less than 2 cm as assessed by physical examination and MRI.

2 assessment of response

After completing the chemotherapy cycles, an assessment is conducted to evaluate the response to the treatment.

This involves a physical examination and imaging tests, such as an MRI, to measure the size of the tumor.

A successful response is indicated by a reduction in the tumor size to less than 2 cm.

3 fertility sparing surgery

If the tumor has responded well to chemotherapy, the next step is fertility sparing surgery.

This surgery aims to remove the cancerous tissue while preserving the ability to have children in the future.

No additional therapy is planned after this surgery if the treatment is successful.

4 follow-up

Regular follow-up appointments are scheduled to monitor health and ensure the cancer has not returned.

These appointments may include physical exams, imaging tests, and other assessments as needed.

Who Can Join the Study?

Must have a confirmed diagnosis of invasive cervical cancer with specific types: adenocarcinoma, adenosquamous, or squamous.
The cancer stage should be FIGO 2018 IB2, with tumor size between more than 2 cm and up to 4 cm, confirmed by MRI imaging.
Must be between 18 and 40 years old.
Must be premenopausal and wish to preserve fertility.
Must not have received any prior treatment for the cancer lesion, except for diagnostic procedures like cone biopsy or LEEP, but a measurable tumor of more than 2 cm and up to 4 cm is required.
Must agree to use effective birth control methods before, during, and for at least one year after the study.
A pregnancy test is required within 7 days before joining the study.
Must have completed 3 cycles of chemotherapy and shown a reduction in tumor size to less than 2 cm.
Must have a performance status of 2 or less, which means being able to carry out all self-care but unable to carry out any work activities.
Must have normal organ and bone marrow function, which includes specific levels of blood cells and liver and kidney function tests.
Must not have any active uncontrolled infections, but those on antibiotics are eligible.
The disease must be measurable according to specific medical criteria called RECIST 1.1.
Must be able to understand and willing to sign a consent form to participate in the study.

Who Cannot Join the Study?

Patients who have cancer that has spread to the lymph nodes cannot participate. Lymph nodes are small glands that are part of the body’s immune system.
Patients with cervical cancer lesions larger than 4 cm cannot participate. Lesions are areas of abnormal tissue.
Patients who are not women cannot participate, as the study is only for women.
Patients who are not within the specified age range cannot participate. The age range is not specified here, but it is important for eligibility.
Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups that may 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
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
University Hospital Maastricht	Maastricht	The Netherlands

Other Sites

Site Name	City	Country
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Catharina Ziekenhuis Stichting	Eindhoven	The Netherlands
Netherlands Cancer Institute	Amsterdam	The Netherlands
Azftdxlom Uxz	Amsterdam	The Netherlands
Sqfnwqfky Rnupzzh Uifwziqrdi Mfxxeid Cyjsnw	Nijmegen	The Netherlands
Latkl Uozapyquiqje Mhdmhjn Cyjuqyr (ucfom	Leiden	The Netherlands
Uupmcqwmmqvt Mhpxbvc Ccihlcr Gqjwgkiln	Groningen	The Netherlands

Trial status

Country	Status	Recruitment Start
Italy	Not yet recruiting	23.02.2021
The Netherlands	Recruiting	23.02.2021

Trial locations

Investigated drugs:

Neoadjuvant Chemotherapy (NACT) is a treatment given before the main treatment. In this trial, it is used to shrink cervical cancer tumors in women with stage IB2 cervical cancer. The goal is to make the tumors smaller and easier to remove surgically while preserving fertility. This approach helps in reducing the size of the cancer before undergoing surgery.

Fertility Sparing Surgery (FSS) is a surgical procedure aimed at removing the cancer while preserving the reproductive organs. This type of surgery is important for women who wish to maintain their ability to have children in the future. In this trial, FSS is performed after the neoadjuvant chemotherapy to ensure that the cancer is effectively treated while keeping the possibility of future pregnancies.

Cervical cancer – Cervical cancer is a type of cancer that occurs in the cells of the cervix, which is the lower part of the uterus connecting to the vagina. It often begins with precancerous changes in the cervix, which can develop into cancer over time if not detected and treated early. The disease progresses as the cancer cells grow and invade deeper tissues of the cervix and potentially spread to other parts of the body. Early stages may not show symptoms, but as it advances, symptoms like abnormal vaginal bleeding, pelvic pain, or pain during intercourse may occur. The progression of cervical cancer is typically categorized by stages, with stage IB2 indicating a tumor larger than 2 cm but not exceeding 4 cm. Regular screening and early detection are crucial in managing the progression of this disease.

Trial ID:

2023-507230-24-00

NCT ID:

NCT04016389

Trial Phase:

Therapeutic exploratory (Phase II)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study on Fertility Preservation in Women with Stage IB2 Cervical Cancer Using Cisplatin, Carboplatin, and Paclitaxel Before Surgery

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?