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Maintenance Chemotherapy or Observation Following Induction Chemotherapy and Radiation Therapy in Treating Younger Patients With Newly Diagnosed Ependymoma


Title ACNS0831: Phase III Randomized Trial of Post-Radiation Chemotherapy in Patients with Newly Diagnosed Ependymoma Ages 1 to 21 years
Therapeutic Area Ependymoma (Floating)
Principal Investigator Michael Kelly
Min Age 1 Years
Max Age 21 Years
Gender Both
Contact Jennifer Truong
617-636-8885
More Information https://clinicaltrials.gov/ct2/show/NCT01096368

Overview

This study is being done to evaluate what effects, if any, chemotherapy can have when added to the standard of care for this type of cancer. The current standard of care for this type of cancer is a surgery, to remove as much of the tumor as possible, followed by radiation. It will look at if chemotherapy, when added to the standard of care, affects the cancer from coming back.

Study Details

Inclusion Criteria

  • Must be diagnosed with Intracranial Ependymoma
  • Muse be within 56 days of tumor resection
  • Otherwise normal organ function

Exclusion Criteria

  • No evidence of metastases
  • No prior treatment allowed (other than tumor resection)
  • No pregnant or lactating females

Study Requirements

Subjects will receive study intervention based on how much tumor is removed during surgery, the tumor’s location, and the type of cells that make up their tumor. If a subject’s tumor has completely gone away, but the location and cellular make up are not ideal, subjects will be randomly assigned to one of two groups. Group 1 will receive radiation and chemotherapy, and Group 2 will receive radiation alone and then closely observed (this is the standard treatment). We will have no control over to which group subjects will be assigned. All other subjects will receive standard treatment.

Depending on which intervention subjects undergo this study will range from 7 weeks to about 25 weeks time. All subjects will be followed for up to 10 years after completion of the study.

Subjects can participate in an optional portion of the study involving the use of blood and tumor tissue remaining after the completion of the study for biological testing and storage for future research for this type of cancer or other health problems.