Study on Maintenance Chemotherapy or Observation After Initial Treatment for Newly Diagnosed Ependymoma

Sponsor: Children's Oncology Group

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT01096368

Provider View

This clinical trial is exploring whether adding maintenance chemotherapy after surgery and radiation can improve outcomes for children and young adults with newly diagnosed ependymoma, a type of brain tumor. The study includes patients aged 1-21 years and compares different treatment approaches based on tumor characteristics.

Patient Parameters

Program Overview

The main goal of this study is to find out if giving additional chemotherapy after surgery and radiation helps children and young adults with newly diagnosed ependymoma, a type of brain tumor. The study involves patients aged 1-21 years and looks at whether maintenance chemotherapy can improve survival and prevent the tumor from coming back. It also examines the effects of chemotherapy on quality of life and brain function over time. The study includes different groups based on the tumor's location and how much of it was removed during surgery.

Description

This study is designed to see if adding maintenance chemotherapy after surgery and radiation can help children and young adults with newly diagnosed ependymoma, a type of brain tumor. The study is divided into different groups based on the tumor's location and how much of it was removed during surgery.

  • Group 1: Patients with certain types of ependymoma that were completely removed during surgery are monitored without additional chemotherapy.
  • Group 2: Patients with other types of ependymoma or those with remaining tumor after surgery receive radiation followed by maintenance chemotherapy.
  • Group 3: Similar to Group 2, but these patients are monitored after radiation without additional chemotherapy.
  • Group 4: Patients with remaining tumor after initial treatment receive additional chemotherapy and possibly another surgery before continuing with the study treatment.

The chemotherapy drugs used in this study include vincristine, carboplatin, cyclophosphamide, etoposide, and cisplatin. These drugs work in different ways to stop tumor growth. Radiation therapy is also used to target and kill tumor cells. The study aims to determine the best approach to improve survival and quality of life for patients with ependymoma.

Eligibility Criteria

Inclusion Criteria

  • Newly diagnosed with intracranial ependymoma, including classic or anaplastic types and certain subtypes.
  • No minimum performance level required; patients may have neurological issues due to the tumor or surgery.
  • Written informed consent must be signed by patients or their guardians.
  • All regulatory requirements for human studies must be met.

Exclusion Criteria

  • Evidence of metastatic disease, meaning the cancer has spread beyond the primary site.
  • Diagnosis of spinal cord ependymoma or other specific types not eligible.
  • No prior treatment other than surgery and corticosteroids.
  • Pregnant females are not eligible.
  • Post-menarchal females must have a negative pregnancy test.
  • Participants must agree to use effective contraception if of reproductive potential.
  • Lactating females must agree not to breastfeed during the study.

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