All studies
Active not recruitingPHASE3INTERVENTIONAL

Induction Chemotherapy Plus Chemoradiation as First Line Treatment for Locally Advanced Cervical Cancer

This study is investigating a new approach for women with locally advanced cervical cancer. Currently, the standard treatment is a combination of chemotherapy and radiation (chemoradiation). However, for some women, this isn't enough to stop the cancer from spreading. Researchers are exploring if giving a short course of different chemotherapy drugs (Paclitaxel and Carboplatin) just before the standard chemoradiation could be more effective. Previous research showed promising results, with a good number of women responding well and tolerable side effects. This larger study will compare whether adding this initial chemotherapy improves overall survival compared to receiving only the standard chemoradiation.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
University College, London
Enrolment target
500
Start
08 Nov 2012
Estimated completion
01 Dec 2026

What is this study about?

This study is about finding better ways to treat locally advanced cervical cancer. For the past ten years, the usual treatment has involved a combination of chemotherapy and radiation therapy, often called chemoradiation. While this treatment works well for many women, unfortunately, some women still experience the cancer spreading, which doctors call a failure to control systemic disease.

Researchers have been looking for ways to improve these outcomes. They previously conducted a smaller study that suggested giving a short course of chemotherapy before the standard chemoradiation might help. In that earlier study, a good number of women's tumours shrank or disappeared after this extra chemotherapy, and the side effects were manageable. Importantly, this additional treatment didn't seem to make the standard chemoradiation less effective.

Now, this larger study aims to confirm these findings. Doctors want to see if adding this initial chemotherapy truly helps women live longer and prevents the cancer from returning. They will involve about 770 women and randomly assign them to either receive the new short course of chemotherapy followed by chemoradiation, or just the standard chemoradiation alone. This comparison will help determine if the new approach is a significant step forward in treating locally advanced cervical cancer.

Key takeaways

  • This study compares a new treatment plan with the current standard for locally advanced cervical cancer.
  • The new plan adds extra chemotherapy before the usual chemoradiation.
  • The goal is to see if this new approach helps women live longer and keeps cancer away.
  • About 770 women will participate, assigned by chance to one of two groups.
  • Participation involves treatment and a long-term follow-up period.

Who may be eligible?

To join this study, you would need to be a woman aged 18 or older with cervical cancer that hasn't spread too far. Specifically, your cancer needs to be a certain type (squamous, adeno, or adenosquamous carcinoma) and within stages that are suitable for powerful chemoradiation treatment. You'd also need to be generally healthy enough to receive the study treatments, including chemotherapy and radiation, with good kidney, liver, and blood cell function.

There are also some reasons why you might not be able to join. For example, if you've had certain other cancers recently, or if your cancer has spread beyond specific areas in your pelvis. If you've had previous radiation therapy to your pelvis, or certain other medical conditions like uncontrolled heart disease, you would also not be eligible. The study team will review all your medical information carefully to make sure it's safe and appropriate for you to participate.

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.

  1. Are you female, aged 18 or over?
  2. Do you have a diagnosis of locally advanced cervical cancer?
  3. Are you generally well enough for strong cancer treatments?
  4. Do you have suitable kidney, liver, and blood test results?
  5. Have you not had certain other cancers recently, or previous pelvic radiation?
  6. Has your cancer not spread to distant parts of your body?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first be randomly assigned to one of two groups: either receiving a short course of chemotherapy for six weeks followed by standard chemoradiation, or receiving standard chemoradiation alone. The specific chemotherapy drugs used in the first group are called carboplatin and paclitaxel, and these would be given weekly. Following this, both groups would receive standard chemoradiation, which involves chemotherapy (cisplatin) given at the same time as radiation therapy.

Throughout the study, you would have regular visits for medical checks, blood tests, and scans to monitor your health and how the treatment is working. The treatment phase for the initial chemotherapy and chemoradiation would last several weeks. After completing your treatment, you would enter a follow-up period that will last for five years, during which you'll continue to have regular check-ups to track your progress and long-term health. The total duration of active treatment and follow-up for this study is approximately nine years.

Potential risks and benefits

Taking part in a clinical trial offers the potential benefit of receiving a new treatment approach that might be more effective than current standard care. However, like all medical treatments, there are potential risks and side effects associated with the chemotherapy and radiation involved. The study team will explain these in detail, and your health will be closely monitored. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (35)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Instituto do Câncer do Estado de São Paulo
    Verified postcode
    São Paulo, Brazil
  • Chittaranjan National Cancer Institute (CNCI)
    Verified postcode
    Kolkata, India
  • Saroj Gupta Cancer Centre and Research Institute
    Verified postcode
    Kolkata, India
  • Istituto Europeo di Oncologia
    Verified postcode
    Milan, Italy
  • Instituto Nacional de Cancerologia (INCAN)
    Verified postcode
    Mexico City, Mexico
  • North Devon District Hospital
    Verified postcode
    Barnstaple, United Kingdom
  • University College London Hospital
    Verified postcode
    London, United Kingdom
  • Weston Park Hospital
    Verified postcode
    Sheffield, United Kingdom
  • Belfast City Hospital
    Verified postcode
    Belfast, United Kingdom
  • Pilgrim Hospital
    Verified postcode
    Boston, United Kingdom
  • Royal Sussex County Hospital
    Verified postcode
    Brighton, United Kingdom
  • Velindre Cancer Centre
    Verified postcode
    Cardiff, United Kingdom

Common questions

What is 'locally advanced' cervical cancer?

It means the cancer has grown into nearby tissues, but it hasn't spread to distant parts of your body.

What does 'chemoradiation' mean?

It's a treatment where you get chemotherapy medicines at the same time as radiation therapy, as they often work better together.

Why would I get extra chemotherapy before the main treatment?

Researchers are hoping this extra chemotherapy will shrink the tumour more, making the main treatment more effective and reducing the risk of the cancer coming back.

Will I definitely get the new treatment combination?

No, because it's a 'randomised' study, you'll be put into one of two groups by chance – either the new combination or the standard treatment. This helps ensure a fair comparison.

How long will I be involved in the study?

The active treatment might last a few months, but you'll have follow-up appointments for approximately five years after your treatment finishes.

How to find out more

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

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