Radiation + Chemotherapy for Medulloblastoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the effectiveness of different doses and volumes of radiation therapy combined with chemotherapy in treating children with medulloblastoma, a type of brain cancer. The researchers aim to determine if a lower radiation dose can match the effectiveness of the standard dose, potentially reducing side effects for young patients. Children who have undergone surgery for newly diagnosed standard-risk medulloblastoma, with minimal remaining tumor and no metastasis, may be suitable candidates for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking treatment advancements.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but it does allow prior use of corticosteroids. It requires that you have not had any prior chemotherapy or radiotherapy.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the chemotherapy drugs used in this trial have different safety profiles based on other studies. For example, Cisplatin can improve survival rates in children with medulloblastoma, but it may cause hearing loss as a side effect. To reduce this risk, trials often combine it with sodium thiosulfate. Another drug in the trial, Cyclophosphamide, has been studied for its effects on young patients. One study found no major differences in severe side effects like low white blood cell count or kidney and liver damage when partially replaced with other drugs. These medications have been part of established treatment plans that have shown consistent results in real-world patients.
Since this trial is in a late phase, earlier studies have already reviewed the safety of these treatments. This suggests they are generally well-tolerated, but participants should be aware of possible side effects, especially those affecting hearing and blood cell counts.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for medulloblastoma because they are exploring innovative ways to use radiation therapy in combination with chemotherapy. Unlike the standard treatments, which often use a one-size-fits-all approach, this trial is testing different radiation doses and methods tailored to age groups and tumor spread. Specifically, they are comparing limited-dose craniospinal irradiation (LDCSI) and standard-dose craniospinal irradiation (SDCSI), as well as different localized radiation techniques like involved-field radiation therapy (IFRT) and posterior fossa radiation therapy (PFRT). This personalized approach could potentially reduce side effects and increase treatment effectiveness, offering a more targeted alternative to traditional methods.
What evidence suggests that this trial's treatments could be effective for medulloblastoma?
Research shows that combining radiation therapy with chemotherapy effectively treats medulloblastoma in children. In this trial, participants will receive different treatment combinations, including radiation therapy and chemotherapy drugs such as cisplatin, vincristine, cyclophosphamide, and lomustine. Studies indicate that these chemotherapy drugs can improve survival rates. For example, vincristine has been linked to a 90.5% chance of being free from disease progression for three years in patients with average risk. Although cisplatin can cause side effects like hearing loss, it has increased survival rates when included in treatment plans. Overall, chemotherapy has proven more protective than radiation therapy alone, enhancing long-term survival chances.15678
Who Is on the Research Team?
Jeff M Michalski
Principal Investigator
Children's Oncology Group
Are You a Good Fit for This Trial?
This trial is for young patients aged 3-7 with newly diagnosed standard-risk medulloblastoma, a type of brain tumor. They should have had surgery but no prior chemotherapy or radiotherapy, and their cancer shouldn't have spread. Their blood counts and organ functions need to meet specific criteria, they can't be pregnant or nursing, and must use effective contraception if applicable.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Radiation Therapy
Patients undergo radiation therapy with doses according to their Arm randomization
Chemotherapy
Patients receive vincristine intravenously on specified days during radiation therapy
Maintenance Chemotherapy
Patients receive maintenance chemotherapy with two different regimens for a total of 9 courses
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cisplatin
- Craniospinal Irradiation
- Cyclophosphamide
- Involved-Field Radiation Therapy
- Lomustine
- Radiation Therapy
- Vincristine Sulfate
Trial Overview
The study compares different radiation therapy doses and volumes when combined with chemotherapy drugs like vincristine sulfate, lomustine, cisplatin, and cyclophosphamide after surgery in these children. It aims to find out which radiation strategy works best at killing remaining tumor cells without causing unnecessary harm.
How Is the Trial Designed?
6
Treatment groups
Experimental Treatment
Active Control
See Detailed Description (Arm V)
See Detailed Description (Arm III)
See Detailed Description (Arm II)
See Detailed Description (Arm I)
See Detailed Description (Arm IV)
See Detailed Description (Arm VI)
Radiation Therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
Find a Clinic Near You
Who Is Running the Clinical Trial?
Children's Oncology Group
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Citations
Cumulative Cisplatin Dose Is Not Associated With Event-Free ...
Survival rates for children with medulloblastoma have risen over the past decade, in part due to the addition of cisplatin-containing adjuvant chemotherapy.
Impact of partial substitution of cisplatin with ...
No significant differences were found in grade ≥ 3 leukopenia, nephrotoxicity or hepatotoxicity. The 2-year overall survival was 96.4% (95% CI: ...
3.
medicine.yale.edu
medicine.yale.edu/ycci/clinicaltrials/trial/a-study-of-treatment-for-medulloblastoma-using-sodium-thiosulfate-to-reduce-hearing-loss/A Phase 3 Study of Sodium Thiosulfate for Reduction of ...
Previous studies with STS have shown that it may help reduce or prevent hearing loss caused by cisplatin. In the low-risk medulloblastoma ...
4.
cancerblog.mayoclinic.org
cancerblog.mayoclinic.org/2024/05/29/advances-in-medulloblastoma-treatment-for-children/Advances in medulloblastoma treatment for children
Cisplatin, a chemotherapy drug effective in treating medulloblastoma, is associated with hearing loss. Research has shown this may be due to the ...
The effect of locally delivered cisplatin is dependent on an ...
Our results demonstrate that intratumoral cisplatin treatment was effective with a narrow therapeutic window and may be an efficient approach for glioma or ...
Cumulative cisplatin dose is not associated with event-free or ...
Results: Eight-year event-free survival (EFS) and overall survival (OS) estimates were 78.2 ± 2.6% and 83.9 ± 2.4%, respectively. Only 73 patients received the ...
Medulloblastoma in the Modern Era: Review of ...
Outcomes remain inferior for patients with high-risk disease (60–70% 5-year EFS and OS), motivating investigation of treatment intensification strategies [5, 6, ...
Impact of partial substitution of cisplatin with ...
Partial substitution of cisplatin with cyclophosphamide showed a better toxicity profile, particularly for ototoxicity and neurotoxicity, with no significant ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.