RecruitingNAINTERVENTIONAL

FIGO 2018 Stage IB2 Cervical Cancer Treated With Neoadjuvant Chemotherapy Followed by Fertility Sparing Surgery

This study is for women with a specific type of cervical cancer (FIGO 2018 Stage IB2) who want to preserve their ability to have children after treatment. Normally, surgery for this cancer can lead to long-term side effects, including not being able to get pregnant. Researchers are investigating if giving chemotherapy first, before surgery, can help women keep their fertility. The chemotherapy drugs used are common ones like cisplatin or carboplatin, along with paclitaxel. After chemotherapy, doctors will check if the treatment is working. If it is, women will have a specific type of surgery called a trachelectomy, which aims to preserve the womb. This study hopes to find a way to treat cervical cancer effectively while greatly improving a woman's chances of having a family in the future.

At a glance

Status

Recruiting

Phase

Sponsor

University Health Network, Toronto

Enrolment target

Start

11 Feb 2020

Estimated completion

01 Dec 2028

Cervical Cancer

What is this study about?

This research study is looking for women with a particular type of cervical cancer, called Stage IB2, who are still able to have children and want to keep that option open after their cancer treatment. Usually, surgery for this type of cervical cancer can sometimes make it difficult or impossible to get pregnant later on.

The main idea behind this study is to see if giving chemotherapy medicine *before* surgery can help reduce the size of the cancer, making the surgery less extensive and more likely to preserve a woman's fertility. The chemotherapy drugs used, cisplatin or carboplatin along with paclitaxel, are common treatments for cervical cancer. The hope is that by shrinking the tumour first, doctors can perform a different type of surgery called a trachelectomy, which leaves the rest of the womb intact.

After the chemotherapy and surgery, doctors will carefully monitor your recovery and decide if any further treatment is needed. This might involve more chemotherapy, radiotherapy, or in some cases, a different surgery if the initial treatment hasn't been as effective as hoped. The ultimate goal is to find the best way to treat cervical cancer while also helping women preserve their ability to have children.

Key takeaways

A new approach to treating cervical cancer (Stage IB2) that prioritises fertility.
Combines chemotherapy *before* fertility-sparing surgery (trachelectomy).
Uses common chemotherapy drugs: cisplatin or carboplatin with paclitaxel.
Aims to reduce the need for more radical surgery that impacts fertility.
Strict age (18-40) and cancer stage criteria apply.

Who may be eligible?

This study is specifically for women aged 18 to 40 who have been diagnosed with a certain stage of cervical cancer (FIGO 2018 Stage IB2) that measures between 2cm and 4cm. You should also be able to get pregnant and want to keep your fertility. Importantly, you shouldn't have had any treatment for your cancer yet, and you need to be generally well enough to go through the treatment.

Before taking part, doctors will do some tests to make sure your organs and blood are healthy. You also need to agree to use effective contraception during the study and for at least a year afterwards. If you have other serious health problems, are pregnant, or have a known allergy to the study medications, you likely won't be able to join.

After you complete the initial chemotherapy, there are further checks. To be able to have the fertility-sparing surgery, your cancer must have responded well to the chemotherapy, meaning it has shrunk to less than 2cm.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 40 years old?
Do you have a diagnosis of FIGO 2018 Stage IB2 cervical cancer?
Are you able to get pregnant and want to keep your fertility?
Have you *not* had any previous treatment for this cervical cancer?
Are you generally well and fit enough for treatment?
Could you agree to use contraception during and after the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first receive a course of chemotherapy, which involves medication given over a period of time. After completing the chemotherapy, you'll have scans and checks to see how well the treatment has worked. If the treatment has been successful in shrinking the cancer, you will then have a type of surgery called a trachelectomy, which is designed to remove the cancer while keeping your womb to preserve fertility. Following surgery, doctors will regularly monitor your recovery and health. Depending on how everything progresses, you might need further treatments like more chemotherapy or radiotherapy, or, in some cases, a different surgery. Throughout the study, you'll have regular appointments for check-ups and tests. The total duration of your participation will depend on your individual treatment plan and recovery, and might involve follow-up over an extended period.

Potential risks and benefits

Taking part in this study could potentially offer the benefit of preserving your fertility while still effectively treating your cervical cancer, which might not be an option with traditional surgery alone. However, like all medical treatments, there are potential risks and side effects associated with chemotherapy and surgery, which your doctor will explain in detail. These can include anything from feeling unwell to more serious complications. You will be closely monitored by a medical team throughout the study. Remember, your participation is voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual care.

Locations (4)

MD Anderson Cancer Centre
Verified postcode
Houston, United States· Terminated
Sunnybrook Health Sciences Centre
Verified postcode
Toronto, Canada· Recruiting
Princess Margaret Cancer Centre
Verified postcode
Toronto, Canada· Recruiting
L'Hôtel-Dieu de Québec
Verified postcode
Québec, Canada· Recruiting

Common questions

What is 'fertility-sparing surgery'?

It's a type of surgery, called a trachelectomy, that removes the cancer but aims to leave most of your womb and ovaries, so you can still potentially have children in the future.

Why chemotherapy before surgery?

The idea is to shrink the cancer with chemotherapy first, making the surgery less extensive and increasing the chances of keeping your fertility.

What are platinum-based chemotherapy drugs?

These are strong anti-cancer medicines like cisplatin or carboplatin that are commonly used to treat different types of cancer, including cervical cancer.

What happens if the chemotherapy doesn't work?

If the chemotherapy doesn't shrink the cancer enough, your doctors will discuss other treatment options with you, which might include further chemotherapy, radiotherapy, or a different type of surgery.

Can I still get pregnant if I take part?

The goal of this study is to help preserve your ability to get pregnant. However, fertility can still be affected, and successful pregnancy is not guaranteed. You must use contraception during the study.

How to find out more

Stephanie Lheureux, M.D.

stephanie.lheureux@uhn.ca 416-946-2818 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.