Phase III Randomized Trial of Post-Radiation Chemotherapy in Patients with Newly Diagnosed Ependymoma Ages 1 to 21 years

Overview

This randomized phase III trial is studying maintenance chemotherapy to see how well it works compared to observation following induction chemotherapy and radiation therapy in treating young patients with newly diagnosed ependymoma.

Description

The purpose of this study is to determine the event-free survival (EFS) and overall survival (OS) of children with completely resected ependymoma treated with maintenance chemotherapy comprising vincristine sulfate, cisplatin, etoposide, and cyclophosphamide (VCEC) versus observation following post-operative conformal radiotherapy (cRT).

Eligibility

You may be eligible for this study if you meet the following criteria:

  • Conditions: Ependymoma,Children's Cancers,Children's Cancers
  • Age: Between 1 Years - 21 Years
  • Gender: Male or Female

Inclusion Criteria

Patients must be newly diagnosed with histologically confirmed intracranial ependymoma; patients with classic ependymoma (WHO II) or anaplastic ependymoma (WHO III) are eligible, as are various subtypes described as clear cell, papillary, cellular or a combination of the above

Exclusion Criteria

Patients with evidence of metastatic disease will be excluded

Patients with a diagnosis of spinal cord ependymoma, myxopapillary ependymoma, subependymoma, ependymoblastoma, or mixed glioma are NOT eligible

No prior treatment other than surgical intervention and corticosteroids; patients are allowed to have had more than one attempt at resection prior to enrollment

Pregnant female patients are not eligible for this study

Post-menarchal females may not participate unless a pregnancy test with a negative result has been obtained

Males and females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method

Lactating females may not participate unless they have agreed not to breastfeed a child while on this study


Additional Information:
Participants will not be paid for their participation.

Updated on 20 Nov 2022 . Study ID: TX500

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