RecruitingPHASE3INTERVENTIONAL

Clinical Trial for Patients With a Stage IV Childhood Renal Tumor, Comparing Upfront Vincristine, Actinomycin-D and Doxorubicin (Standard Arm) With Upfront Vincristine, Carboplatin and Etoposide (Experimental Arm)

This clinical trial is for children with a specific type of kidney cancer called Wilms tumor that has spread to other parts of the body. Doctors want to see if a newer combination of chemotherapy drugs, called VCE (Vincristine, Carboplatin, and Etoposide), is as effective as the current standard treatment, VAD (Vincristine, Actinomycin-D, and Doxorubicin). The main goal is to find a treatment that works well but might have fewer long-term side effects on the heart or liver. The study will also use detailed scans reviewed by experts to better understand how the cancer is responding to treatment. This aims to improve the treatment decisions for each child.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Assistance Publique Hopitaux De Marseille

Enrolment target

110

Start

03 Feb 2023

Estimated completion

03 Oct 2033

Childhood Renal Tumor

What is this study about?

When young people are diagnosed with Wilms tumor, a type of kidney cancer, and the cancer has spread, doctors need to choose the best treatment. Currently, the standard chemotherapy treatment uses three drugs: Vincristine, Actinomycin-D, and Doxorubicin, often called VAD. While VAD is effective and helps many children, sometimes Doxorubicin can affect the heart, and Actinomycin-D can affect the liver over time. Because of these potential long-term issues, doctors are always looking for ways to treat the cancer just as well, but with fewer harsh side effects.

This study looks at a different chemotherapy combination called VCE (Vincristine, Carboplatin, and Etoposide). These drugs are already known to be effective against Wilms tumor and have been used successfully in other childhood cancers or as a different option for Wilms tumor. The hope is that VCE will be just as good at shrinking the tumor and helping children get better, but with less strain on their heart and liver. This could mean a better quality of life for children in the years after their treatment.

Another important part of this study is how doctors look at scans. Sometimes, very small spots on scans, called 'CT-only nodules,' are hard to assess. This trial will use a special central review process where expert radiologists carefully examine all the scans at the start and after the initial chemotherapy. This detailed review will help doctors get a clearer picture of how much the cancer has spread and how it's responding to treatment, allowing them to make more precise treatment plans tailored for each child.

Key takeaways

This study is for children with Wilms tumor that has spread.
It compares two different chemotherapy treatments: VAD (standard) and VCE (new).
The main goal is to find a treatment that is effective but has fewer long-term side effects.
Expert radiologists will review scans to help make better treatment decisions.
The study aims to improve future treatments for all children with Wilms tumor.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is specifically looking for children who have been diagnosed with a Wilms tumor that has spread to other parts of their body. This means the cancer isn't just in the kidney anymore.

To join, detailed scans like chest and tummy CT or MRI must show at least one small, clear spot (not hard like bone) that's at least 3 millimeters in size, which doctors suspect is the cancer that has spread. These findings will also need to be confirmed by a team of expert reviewers.

There are no specific reasons given that would stop someone from joining the study, other than not meeting the above criteria. The study is open to both boys and girls up to 17 years old.

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.

Is my child diagnosed with Wilms tumor?
Has the doctor told me the cancer has spread?
Are there any spread cancer spots visible on my child's scans?
Is my child 17 years old or younger?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive chemotherapy treatment. You would either receive the standard treatment (VAD) or the new treatment being studied (VCE). The specific details of how often and for how long you receive these treatments would be explained by your medical team.

Throughout the study, you would have regular hospital visits for check-ups, blood tests, and scans (like CT or MRI scans) to monitor your health and how the cancer is responding to treatment. These scans would be reviewed by a central team of experts. After the initial chemotherapy, you would likely have surgery to remove the kidney tumor, followed by more chemotherapy and possibly radiotherapy, depending on your individual situation. The study aims to look at how you are doing for two years after your treatment finishes, with an additional longer-term follow-up for 10 years to specifically check for any long-term effects, such as on the heart.

Potential risks and benefits

Taking part in a clinical trial offers the potential benefit of receiving what might be a more effective treatment or one with fewer side effects in the long run. By comparing a new chemotherapy combination to the standard one, researchers hope to improve care for children with Wilms tumor. However, as with any medical treatment, there are potential risks. The new treatment might have its own set of side effects, which your medical team will discuss with you. You will be closely monitored for any issues throughout the study. It's very important to remember that participating in a clinical trial is always voluntary, and you have the right to withdraw at any time without affecting your medical care.

Locations (1)

Assistance Publique Hopitaux de Marseille
Verified postcode
Marseille, France· Recruiting

Common questions

What is Wilms tumor?

Wilms tumor is a type of kidney cancer that most commonly affects children.

What does 'metastatic' mean?

It means the cancer has spread from where it started in the kidney to other parts of the body.

Are there different treatments for Wilms tumor?

Yes, doctors use different types of chemotherapy, surgery, and sometimes radiotherapy to treat Wilms tumor. This study compares two chemotherapy combinations.

What are the main differences between VAD and VCE?

They are different combinations of chemotherapy drugs. VCE is being studied to see if it works as well as VAD but with potentially fewer long-term side effects on the heart or liver.

How long will this study last?

Patients will be followed for two years after treatment ends, with a longer 10-year check-up specifically for long-term health effects.

How to find out more

Arnauld VERSCHUUR

arnauld.verschuur@ap-hm.fr +33.491.38.84.78 Official trial record

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