Radiation + Chemotherapy for Medulloblastoma

Recruiting in Palo Alto (17 mi)

+238 other locations

Overseen by Jeff M Michalski

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Children's Oncology Group

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

This randomized phase III trial is studying how well standard-dose radiation therapy works compared to reduced-dose radiation therapy in children 3-7 years of age AND how well standard volume boost radiation therapy works compared to smaller volume boost radiation therapy when given together with chemotherapy in treating young patients who have undergone surgery for newly diagnosed standard-risk medulloblastoma. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as vincristine, cisplatin, lomustine, and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving radiation therapy with chemotherapy after surgery may kill any remaining tumor cells. It is not yet known whether standard-dose radiation therapy is more effective than reduced-dose radiation therapy when given together with chemotherapy after surgery in treating young patients with medulloblastoma.

Research Team

Jeff M Michalski

Principal Investigator

Children's Oncology Group

Eligibility Criteria

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

Fertile patients must use effective contraception

Platelet count > 100,000/uL (transfusion independent)

Hemoglobin > 10 g/dL (transfusions allowed)

Treatment Details

Interventions

• Cisplatin (Alkylating agents)
• Craniospinal Irradiation (Radiation)
• Cyclophosphamide (Alkylating agents)
• Involved-Field Radiation Therapy (Radiation)
• Lomustine (Alkylating agents)
• Radiation Therapy (Radiation)
• Vincristine Sulfate (Vinca alkaloids)

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.

Participant Groups

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

See Detailed Description (Arm V)

Group II: Arm III (3-7 years of age, SDCSI, IFRT) Experimental Treatment 8 Interventions

See Detailed Description (Arm III)

Group III: Arm II (3-7 years of age, LDCSI, PFRT) Experimental Treatment 8 Interventions

See Detailed Description (Arm II)

Group IV: Arm I (3-7 years of age, LDCSI, IFRT) Experimental Treatment 8 Interventions

See Detailed Description (Arm I)

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

See Detailed Description (Arm IV)

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

See Detailed Description (Arm VI)

Radiation Therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

🇪🇺 Approved in European Union as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

🇺🇸 Approved in United States as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

🇨🇦 Approved in Canada as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

🇯🇵 Approved in Japan as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

🇨🇳 Approved in China as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

🇨🇭 Approved in Switzerland as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

New York Medical College Valhalla, NY

UNC Lineberger Comprehensive Cancer Center Chapel Hill, NC

Carolinas Medical Center/Levine Cancer Institute Charlotte, NC

Novant Health Presbyterian Medical Center Charlotte, NC

More Trial Locations

Who Is Running the Clinical Trial?

Children's Oncology Group

Lead Sponsor

Trials

467

Patients Recruited

241,000+

National Cancer Institute (NCI)

Collaborator

Trials

14080

Patients Recruited

41,180,000+

References