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RecruitingPHASE2INTERVENTIONAL

A Study of Lower Radiotherapy Dose to Treat Children With CNS Germinoma

This study is for children and young adults aged 3 to 29 who have a type of brain tumour called CNS germinoma. The study is testing a new approach to treatment: using a lower dose of radiation after chemotherapy (which involves medicines like Carboplatin and Etoposide). Standard radiation therapy uses high-energy rays to kill cancer cells, but it can have side effects. Doctors want to find out if reducing the radiation dose can still effectively treat the tumour while causing fewer long-term problems. This is important because it could improve the quality of life for young patients after treatment. The study also aims to understand how different treatments affect things like hormone balance and thinking skills over time.

At a glance

Status
Recruiting
Phase
PHASE2
Sponsor
Children's Oncology Group
Enrolment target
240
Start
22 Oct 2024
Estimated completion
04 Nov 2033

What is this study about?

This clinical trial is designed to investigate a different way of treating a specific type of brain tumour called CNS germinoma, which affects children and young adults. Currently, treatment often involves chemotherapy followed by radiation therapy. Radiation therapy uses powerful energy – like X-rays – to target and destroy cancer cells. While very effective, it can sometimes lead to side effects in the long run.

The main goal of this study is to see if a *lower dose* of radiation therapy, given after chemotherapy, is just as successful at treating CNS germinomas as the standard, higher dose. The hope is that by reducing the radiation dose, young patients might experience fewer side effects later in life, without making the treatment less effective. The chemotherapy drugs used in this study, Carboplatin and Etoposide, work by stopping or slowing down the growth of cancer cells.

Researchers will be carefully tracking how well the lower-dose radiation works, by looking at things like whether the tumour returns. They will also be studying other important aspects, such as how the treatment affects hormone levels (neuroendocrine function) and thinking abilities (like how quickly someone can process information) in children and young adults over time. This will help doctors understand the overall impact of treatment and potentially improve future care.

Key takeaways

  • This study is for children and young adults with CNS germinoma.
  • It tests if lower-dose radiation after chemotherapy is effective.
  • The goal is to reduce long-term side effects for patients.
  • Chemotherapy uses drugs like Carboplatin and Etoposide.
  • Participation involves scans, blood tests, and symptom questionnaires.

Who may be eligible?

This study is looking for children and young adults between the ages of 3 and 29 years old who have recently been diagnosed with a brain tumour called a germinoma. This includes germinomas found in specific areas of the brain, such as the suprasellar and/or pineal regions, or the basal ganglia and thalamic areas.

You might be eligible even if your tumour has spread slightly to nearby areas or to other parts of the brain or spine. Some specific blood or spinal fluid tests will be looked at to confirm your eligibility. If you've had surgery for your tumour, the imaging scans taken after your surgery will be used to help decide if you can join. You'll also need to be generally well enough to take part in the study, which doctors will assess.

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 between 3 and 29 years old?
  2. Have you been newly diagnosed with a CNS germinoma?
  3. Is your germinoma in specific areas like the suprasellar or pineal region, basal ganglia, or thalamic areas?
  4. Are you generally well enough to participate?
  5. Are your recent MRI scans and blood/spinal fluid tests compatible with the study criteria?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have chemotherapy using medicines called Carboplatin and Etoposide. After chemotherapy, you would then receive radiation therapy, specifically 3-Dimensional Conformal Proton Radiation Therapy or Intensity-Modulated Proton Therapy, but at a lower dose than standard treatment. Throughout the study, you would have regular checks including MRI scans of your brain to monitor the tumour, blood tests, and possibly procedures like a lumbar puncture (where a small sample of fluid is taken from your spine).

Doctors will also collect biospecimens (like tissue samples), and you might be asked to fill out questionnaires about how you are feeling and how the treatment is affecting you. There will also be specific tests to see how your thinking skills are doing over time. The total duration of the chemotherapy and radiation part of the treatment will be determined by the study plan, but follow-up will continue for a longer period to monitor long-term health.

Potential risks and benefits

Taking part in this study could offer the potential benefit of treating your germinoma effectively while possibly reducing the long-term side effects typically associated with higher-dose radiation. However, as with all medical treatments, there are potential risks. Chemotherapy drugs like Carboplatin and Etoposide can cause side effects, and while the radiation dose is lower, radiation therapy itself still carries risks. Your medical team will discuss all known potential risks specific to these treatments with you and your family. You are free to withdraw from the study at any time, for any reason, without it affecting your ongoing medical care.

Locations (109)

  • USA Health Strada Patient Care Center
    Verified postcode
    Mobile, United States· Recruiting
  • Phoenix Childrens Hospital
    Verified postcode
    Phoenix, United States· Recruiting
  • Arkansas Children's Hospital
    Verified postcode
    Little Rock, United States· Recruiting
  • Loma Linda University Medical Center
    Verified postcode
    Loma Linda, United States· Recruiting
  • Children's Hospital Los Angeles
    Verified postcode
    Los Angeles, United States· Recruiting
  • UCSF Benioff Children's Hospital Oakland
    Verified postcode
    Oakland, United States· Recruiting
  • Children's Hospital of Orange County
    Verified postcode
    Orange, United States· Recruiting
  • Lucile Packard Children's Hospital Stanford University
    Verified postcode
    Palo Alto, United States· Recruiting
  • Rady Children's Hospital - San Diego
    Verified postcode
    San Diego, United States· Recruiting
  • UCSF Medical Center-Mission Bay
    Verified postcode
    San Francisco, United States· Recruiting
  • Children's Hospital Colorado
    Verified postcode
    Aurora, United States· Recruiting
  • Connecticut Children's Medical Center
    Verified postcode
    Hartford, United States· Recruiting

Common questions

What is a CNS germinoma?

It's a rare type of brain tumour that typically affects young people. CNS stands for Central Nervous System, which includes the brain and spinal cord.

What is radiation therapy?

It's a cancer treatment that uses high-energy rays or particles to kill cancer cells and shrink tumours in a specific area.

What is chemotherapy?

Chemotherapy uses medicines to kill cancer cells throughout the body, or to stop them from growing and dividing.

Will I still get effective treatment with a lower radiation dose?

That's exactly what this study aims to find out. Doctors hope to show that a lower dose can be just as effective while causing fewer long-term side effects.

What are long-term side effects?

These are health problems that might appear months or years after treatment has finished, such as changes in hormone levels or thinking abilities.

How to find out more

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

Interested in taking part?

Register your interest

Share your details and the research team for "A Study of Lower Radiotherapy Dose to Treat Children With CN…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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