Radiation + Chemotherapy for Medulloblastoma

Recruiting at 238 trial locations

Age: < 65

Sex: Any

Trial Phase: Phase 3

Sponsor: Children's Oncology Group

Disqualifiers: Pregnancy, Prior chemotherapy, Prior radiotherapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

549 Participants Needed

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)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Therapy

Patients undergo radiation therapy with doses according to their Arm randomization

6 weeks

Daily visits (in-person) for radiation therapy

Chemotherapy

Patients receive vincristine intravenously on specified days during radiation therapy

6 weeks

Weekly visits (in-person) for chemotherapy administration

Maintenance Chemotherapy

Patients receive maintenance chemotherapy with two different regimens for a total of 9 courses

54 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years

Every 3 months for 1 year, every 6 months for 2 years, then annually

Treatment Details

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.

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

Who Is Running the Clinical Trial?

Children's Oncology Group

Lead Sponsor

Trials

467

Recruited

241,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+