All studies
Active not recruitingPHASE4INTERVENTIONAL

HeadStart4: Newly Diagnosed Children (<10 y/o) With Medulloblastoma and Other CNS Embryonal Tumors

The HeadStart4 study is looking for children under 10 recently diagnosed with medulloblastoma or other types of CNS embryonal tumours. The main goal is to find the best way to treat these cancers. Researchers are comparing two different high-dose chemotherapy plans given after initial treatment: a single round or three rounds back-to-back. They want to see if the three-round treatment is better at stopping the cancer from returning or getting worse, and if it helps children live longer. They'll also check if the longer treatment causes more side effects or longer hospital stays, to make sure any benefits outweigh the difficulties. Your healthcare team will guide you through the process if your child is eligible.

At a glance

Status
Active not recruiting
Phase
PHASE4
Sponsor
Parth Patel
Enrolment target
250
Start
01 Sep 2015
Estimated completion
01 Dec 2030

What is this study about?

The HeadStart4 study is a research project focusing on children under 10 who have recently been diagnosed with specific types of brain tumours. These include medulloblastoma and other similar cancers called CNS embryonal tumours. The main purpose of this study is to discover the most effective treatment approach for these conditions. Researchers want to improve the chances of recovery and overall well-being for these young patients.

After an initial period of chemotherapy, the study will compare two different ways of giving a stronger, high-dose chemotherapy treatment. One group of children will receive a single intensive course, while another group will have three intensive courses given one after the other. The research team wants to find out if the three-course treatment is more successful at preventing the cancer from returning or getting worse, and if it helps children live longer. They are particularly interested in finding the best balance between powerful treatment and potential side effects.

Ultimately, this study aims to determine if the potentially more demanding three-course treatment plan is truly better for children in the long run, weighing up the benefits against any extra time spent in hospital or more intense side effects, both short-term and long-term. The hope is that this research will lead to better outcomes for children with these challenging cancers.

Key takeaways

  • Targets specific brain tumours in children under 10.
  • Compares single vs. three intensive chemotherapy cycles.
  • Aims to improve long-term survival and prevent cancer return.
  • Explores if more intense treatment offers enough benefit to justify it.
  • Participation involves random assignment to a treatment group.

Who may be eligible?

This study is designed for children who are 10 years old or younger when they are diagnosed with a brain or spinal cord tumour. They must have one of the specific types of tumours the study is focusing on, such as medulloblastoma or other CNS embryonal tumours.

Your child cannot have received any previous radiation or chemotherapy treatments for their cancer, though steroids are usually fine. The treatment plan for the study needs to start quite quickly after their surgery and recent scans. There are also specific details about the type and stage of medulloblastoma that make a child eligible, especially for those aged 6 and over, who need to show signs that the cancer has spread.

If your child has a specific type of medulloblastoma that is known to respond very well to existing treatments, they might follow a slightly different path within the study, receiving a shorter initial treatment and then a single intensive chemotherapy course, without being randomly assigned to one of the two main treatment groups.

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. Is your child 10 years old or younger?
  2. Has your child been recently diagnosed with medulloblastoma or a CNS embryonal tumour?
  3. Has your child NOT had any radiation or chemotherapy yet (steroids are usually okay)?
  4. Can treatment start quickly after surgery and scans?
  5. For medulloblastoma, does your child's specific tumour type and stage fit the study criteria?
Answer every question to see your result.

What does participation involve?

If your child takes part in the HeadStart4 study, they will first receive initial chemotherapy treatment. After this, they will either be randomly assigned to receive one intensive high-dose chemotherapy session or three intensive high-dose chemotherapy sessions given close together. This choice is made by chance, like flipping a coin, to ensure a fair comparison. These treatments are given in the hospital. You can expect regular hospital visits for treatment, check-ups, scans, and blood tests to monitor their health and the treatment's effect. The total duration of participation will depend on the specific treatment plan your child is on and their response, but it will involve ongoing follow-up to track their health over time.

Potential risks and benefits

Taking part in a clinical trial like HeadStart4 may offer the potential benefit of accessing new or intensified treatments that might improve the chances of successful recovery or longer life compared to standard care. However, all medical treatments carry risks. Intensive chemotherapy can cause significant side effects, both in the short term (like fatigue, nausea, hair loss, and increased risk of infection) and potentially in the long term. These side effects will be carefully monitored and managed by the medical team. You have the right to withdraw your child from the study at any time, for any reason, without affecting their future medical care.

Locations (62)

  • Children's of Alabama
    Verified postcode
    Birmingham, United States
  • Phoenix Children's Hospital
    Verified postcode
    Phoenix, United States
  • Arkansas Children's Hospital
    Verified postcode
    Little Rock, United States
  • Loma Linda University Medical Center
    Verified postcode
    Loma Linda, United States
  • Memorial Care Health Services
    Verified postcode
    Long Beach, United States
  • Children's Hospital Los Angeles
    Verified postcode
    Los Angeles, United States
  • Mattel Children's Hospital (UCLA)
    Verified postcode
    Los Angeles, United States
  • UCSF Oakland Benioff
    Verified postcode
    Oakland, United States
  • Children's Hospital Orange County
    Verified postcode
    Orange, United States
  • Children's Hospital Colorado
    Verified postcode
    Aurora, United States
  • Nemours Center for Cancer and Blood Disorders
    Verified postcode
    Wilmington, United States
  • Children's National Medical Center
    Verified postcode
    Washington D.C., United States

Common questions

What kind of tumours is this study for?

This study is for children under 10 with medulloblastoma or other similar brain tumours called CNS embryonal tumours.

What is the main goal of the study?

The main goal is to find out if giving three intensive chemotherapy treatments back-to-back is better than one for preventing the cancer from returning and helping children live longer.

Will my child definitely get the new treatment?

Children in the study will be randomly assigned to either one or three intensive chemotherapy cycles after their initial treatment. It's like a lottery, so neither you nor the doctors decide which one they get, to ensure a fair comparison.

What does 'intensive chemotherapy' mean?

Intensive chemotherapy means giving stronger doses of cancer-fighting medicines, which aims to be more effective at killing cancer cells but can also have more significant side effects.

Can I take my child out of the study if we change our mind?

Yes, you have the right to withdraw your child from the study at any time, and this will not affect their future medical care.

How to find out more

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

Discussion

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