Study on Chemotherapy and Radiation Therapy for Young Patients with High-Risk Medulloblastoma or PNET

Sponsor: Children's Oncology Group

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT00392327

Provider View

This clinical trial is exploring different combinations of chemotherapy and radiation therapy to find the most effective treatment for young patients with newly diagnosed, high-risk medulloblastoma or PNET. The study aims to determine which treatment regimen best stops tumor growth and improves survival rates.

Patient Parameters

Program Overview

This study is testing various chemotherapy and radiation therapy combinations to see which works best for treating young patients with high-risk medulloblastoma or primitive neuroectodermal tumors (PNET). Chemotherapy drugs like vincristine, cisplatin, cyclophosphamide, and carboplatin are used to kill cancer cells or stop them from growing. Radiation therapy uses high-energy rays to target and shrink tumors. The study will compare these treatments to find out which combination is most effective in controlling the cancer.

Description

The main goals of this study are to see if adding carboplatin to radiation therapy improves long-term survival without cancer events and if isotretinoin can also help improve survival rates. Researchers will also look at how well the cancer responds to radiation alone versus radiation with carboplatin, identify markers that could help tailor future treatments, and assess the quality of life and mental functioning of participants during treatment.

Participants will be randomly assigned to one of two groups:

  • Group A: Standard chemotherapy and radiation therapy, followed by maintenance therapy. This includes daily radiation for six weeks and weekly vincristine. After six weeks, patients receive cisplatin, vincristine, and cyclophosphamide every 28 days for six cycles, along with supportive medications to help blood counts recover.

  • Group B: Standard chemotherapy and radiation therapy with added carboplatin, followed by the same maintenance therapy as Group A.

Throughout the study, participants will have regular blood tests, spinal fluid tests, and MRI scans to monitor their health and the cancer's response to treatment.

After completing the study treatment, participants will have follow-up visits for one year to check on their health and any long-term effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Aged 3 to 21 years at diagnosis.
  • Newly diagnosed with high-risk medulloblastoma or PNET, with specific tumor characteristics.
  • Must have had an MRI scan of the brain before surgery and a spinal MRI within a certain timeframe.
  • Must have a spinal fluid test before or shortly after surgery.
  • Must be in relatively good health with a performance score of at least 30.
  • No previous chemotherapy or radiation therapy.
  • Must avoid certain medications that interact with the study drugs.
  • Must have adequate kidney, liver, and blood function as shown by specific tests.
  • Female participants of childbearing age must have a negative pregnancy test and agree to use contraception.
  • Must provide informed consent to participate in the study.

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