← Back to Search

Radiation + Chemotherapy for Medulloblastoma

Phase 3

Waitlist Available

Led By Jeff Michalski

Research Sponsored by Children's Oncology Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No prior radiotherapy

Histologically confirmed medulloblastoma located in the posterior fossa

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

Study Summary

This trial is looking at whether standard-dose radiation therapy, versus reduced-dose, is more effective in children 3-7 years of age who have had surgery for newly diagnosed standard-risk medulloblastoma.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Possible side effects include damage to healthy tissue from radiation, hair loss where the body is irradiated, fatigue from both treatments; nausea/vomiting due to chemo; increased risk of infections; bleeding issues related to low blood cell counts; kidney/liver function changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have not had any radiotherapy treatments before.

Select...

My cancer, medulloblastoma, is confirmed and located in the back of my brain.

Select...

I can perform most of my daily activities without help.

Select...

My bilirubin levels are within normal range for my age.

Select...

My liver enzymes are within normal limits for my age.

Select...

My kidney function is normal or near normal.

Select...

I have never received chemotherapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Event-free Survival (EFS)

Overall Survival (OS)

Secondary outcome measures

Compliance Rates for All Eligible and Evaluable Patients Enrolled Within Time Window 1 (4-15 Months Post Diagnosis)

Compliance Rates for All Eligible and Evaluable Patients Enrolled Within Time Window 2 (27-48 Months Post Diagnosis)

Compliance Rates for All Eligible and Evaluable Patients Enrolled Within Time Window 3 (49 - 72 Months Post Diagnosis)

+15 more

Trial Design

6Treatment groups

Experimental Treatment

Active Control

Group I: Arm V (8-21 years of age, SDCSI, IFRT)Experimental Treatment8 Interventions

See Detailed Description (Arm V)

Group II: Arm III (3-7 years of age, SDCSI, IFRT)Experimental Treatment8 Interventions

See Detailed Description (Arm III)

Group III: Arm II (3-7 years of age, LDCSI, PFRT)Experimental Treatment8 Interventions

See Detailed Description (Arm II)

Group IV: Arm I (3-7 years of age, LDCSI, IFRT)Experimental Treatment8 Interventions

See Detailed Description (Arm I)

Group V: Arm IV (3-7 years of age, SDCSI, PFRT)Active Control7 Interventions

See Detailed Description (Arm IV)

Group VI: Arm VI (8-21 years of age, SDCSI, PFRT)Active Control8 Interventions

See Detailed Description (Arm VI)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vincristine Sulfate

2005

Completed Phase 3

~10150

Radiation Therapy

2017

Completed Phase 3

~7250

Lomustine

2008

Completed Phase 3

~1540

Cisplatin

2013

Completed Phase 3

~1940

Cyclophosphamide

1995

Completed Phase 3

~3770

Involved-Field Radiation Therapy

2002

Completed Phase 3

~1740

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Oncology GroupLead Sponsor

454 Previous Clinical Trials

237,391 Total Patients Enrolled

17 Trials studying Medulloblastoma

3,211 Patients Enrolled for Medulloblastoma

National Cancer Institute (NCI)NIH

13,687 Previous Clinical Trials

40,929,822 Total Patients Enrolled

89 Trials studying Medulloblastoma

9,792 Patients Enrolled for Medulloblastoma

Jeff MichalskiPrincipal InvestigatorChildren's Oncology Group

Media Library

Radiation Therapy Clinical Trial Eligibility Overview. Trial Name: NCT00085735 — Phase 3

Medulloblastoma Research Study Groups: Arm I (3-7 years of age, LDCSI, IFRT), Arm II (3-7 years of age, LDCSI, PFRT), Arm III (3-7 years of age, SDCSI, IFRT), Arm IV (3-7 years of age, SDCSI, PFRT), Arm V (8-21 years of age, SDCSI, IFRT), Arm VI (8-21 years of age, SDCSI, PFRT)

Medulloblastoma Clinical Trial 2023: Radiation Therapy Highlights & Side Effects. Trial Name: NCT00085735 — Phase 3

Radiation Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT00085735 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the Quality-of-Life Assessment metric accepted by the FDA?

"There is some data supporting the efficacy of Quality-of-Life Assessment, as well as multiple rounds of data attesting to its safety, so it received a score of 3."

Answered by AI

Would this research project be interested in people who are over 55 years old?

"This particular study is only for children and adolescents aged 3-21. In total, there are 435 clinical trials for patients under 18 and 1387 for those over 65."

Answered by AI

How many people will be allowed to join this experiment?

"As of right now, this study is not enrolling new patients. The posting date was April 1st, 2004, with the most recent edit taking place on February 25th, 2022. There are currently 76 other trials recruiting patients with medulloblastoma and 1636 Quality-of-Life Assessment studies seeking participants."

Answered by AI

What are the goals of this clinical trial?

"The primary outcome of this clinical trial is Event-free Survival (EFS), which will be assessed over a 3-year period. Secondary outcomes include the Non-posterior Fossa (NPF) Failure Rate, Post-treatment Endocrine Function by CSI Group, and Post-treatment Grade 3+ Hearing loss as Measured by Common Terminology Criteria for Adverse Events (CTCAE) Version (v)4."

Answered by AI

Can you tell us more about other research done on Quality-of-Life Assessment?

"Out of the 1636 ongoing studies related to Quality-of-Life Assessment, 456 are in their third and final phase. The majority of these trials are taking place in Philadelphia, although there are a total of 73737 locations running some form of clinical trial related to this topic."

Answered by AI

In how many different geographical locations is this trial being run today?

"There are over 100 active recruiting sites for this trial, some of which include The Toledo Hospital/Toledo Children's Hospital in Toledo, Ohio, Memorial University Medical Center in Savannah, Georgia, and Helen DeVos Children's Hospital at Spectrum Health in Grand Rapids, Michigan."

Answered by AI

How is Quality-of-Life Assessment most commonly employed?

"Quality-of-Life Assessment is a standard treatment for lymphoma, but can also improve the lives of patients with acute lymphoblastic leukemia (all), ovarian germ cell tumour, and brain."

Answered by AI

How can I sign up to take part in this research project?

"Investigators are looking for 549 pediatric and young adult patients that have been diagnosed with medulloblastoma. Key inclusion criteria for this study are as follows: Platelet count > 100,000/uL (transfusion independent), Histologically confirmed medulloblastoma located in the posterior fossa, Standard-risk disease, Residual tumor ≤ 1.5 cm^2 confirmed by MRI with contrast imaging within 21 days after surgery, Enhanced MRI of the spine within 5 days before surgery OR within 28 days after surgery, Negative cytological examination of CSF after surgery, but before study enrollment, Brain stem involvement allowed,"

Answered by AI

Is it possible to join this research project currently?

"No, this study has stopped recruiting new participants. The trial was originall created on April 1st, 2004 but was most recently updated on February 25th, 2022. For individuals searching for other studies, there are currently 76 trials for medulloblastoma and 1636 for Quality-of-Life Assessment admitting new patients."

Answered by AI

Recent research and studies

Journal of Clinical OncologyJournal

Children's Oncology Group Phase III Trial of Reduced-dose and Reduced-volume Radiotherapy with Chemotherapy for Newly Diagnosed Average-risk Medulloblastoma

Michalski, Jeff M., Anna J. Janss, L. Gilbert Vezina, Kyle S. Smith, Catherine A. Billups, Peter C. Burger, Leanne M. Embry, et al.. 2021. “Children's Oncology Group Phase III Trial of Reduced-dose and Reduced-volume Radiotherapy with Chemotherapy for Newly Diagnosed Average-risk Medulloblastoma”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.20.02730.

clinicaltrials.govStudy

Comparison of Radiation Therapy Regimens in Combination With Chemotherapy in Treating Young Patients With Newly Diagnosed Standard-Risk Medulloblastoma

2004. "Comparison of Radiation Therapy Regimens in Combination With Chemotherapy in Treating Young Patients With Newly Diagnosed Standard-Risk Medulloblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00085735.

All > Medulloblastoma