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


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Trial ID: NCT01096368,7,26500


The primary aim of this randomized phase III trial was to study whether the addition of maintenance chemotherapy delivered after surgical resection and focal radiation would be better than surgery and focal radiation alone. The trial also studied if patients who received induction chemotherapy and then either achieved a complete response or went on to have a complete resection would also benefit from maintenance chemotherapy. Children ages 1-21 years with newly diagnosed intracranial ependymoma were included. There were 2 arms that were not randomized. One arm studied patients with Grade II tumors located in the supratentorial compartment that were completely resected. One arm studied patients with residual tumor and those patients all received maintenance chemotherapy after focal radiation. Chemotherapy drugs, such as vincristine sulfate, carboplatin, cyclophosphamide, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving chemotherapy in combination with radiation therapy may kill more tumor cells and allow doctors to save the part of the body where the cancer started.

Official Title

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

Stanford Investigator(s)


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

   - There is no minimum performance level; children with ependymoma may suffer neurologic
   sequelae as a result of their tumor or surgical measures taken to establish a
   diagnosis and resect the tumor; in the majority of cases, there is neurologic
   recovery; neurologic recovery is not likely to be impeded by protocol therapy

   - REGULATORY: All patients and/or their parents or legal guardians must sign a written
   informed consent

   - REGULATORY: All institutional, Food and Drug Administration (FDA), and National Cancer
   Institute (NCI) requirements for human studies must be met

Exclusion Criteria:

   - Patients with evidence of metastatic disease will be excluded; any evidence of
   non-contiguous spread beyond the primary site as determined by pre or post-operative
   magnetic resonance (MR) imaging of brain, pre or post-operative MR imaging of the
   spine, and post-operative cerebrospinal fluid (CSF) cytology obtained from the lumbar
   CSF space (the requirement for lumbar CSF examination may be waived if deemed to be
   medically contraindicated); CSF cytology from a ventriculostomy or permanent
   ventriculoperitoneal (VP) shunt that reveals the presence of tumor cells is indicative
   of metastatic disease

   - 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


other: clinical observation

radiation: 3-dimensional conformal radiation therapy

drug: cisplatin

drug: cyclophosphamide

drug: etoposide

drug: carboplatin

other: laboratory biomarker analysis

drug: Vincristine

biological: Filgrastim

drug: Mesna


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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Leah White

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