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SIOP Study of Combined Modality Treatment in Childhood Ependymoma


Phase 2
3 Years
20 Years
Open (Enrolling)
Both
Brain and Central Nervous System Tumors

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Trial Information

SIOP Study of Combined Modality Treatment in Childhood Ependymoma


OBJECTIVES:

- Determine the event free and overall survival of children with incompletely resected
localized ependymoma when treated with adjuvant cyclophosphamide, etoposide, and
vincristine followed by radiotherapy.

- Determine the response rate in these patients to this regimen.

OUTLINE: This is a multicenter study.

Patients undergo surgery to remove as much of tumor as possible. Patients with residual
disease proceed to chemotherapy, while those with no residual disease proceed directly to
radiotherapy.

Chemotherapy begins within 3 weeks of surgery and consists of vincristine IV on days 1, 8,
and 15, cyclophosphamide IV over 3 hours on day 1, and etoposide IV over 4 hours on days
1-3. Treatment repeats every 4 weeks for up to 4 courses. Patients who progress after 2
courses proceed to radiotherapy. If residual disease is still present at completion of
chemotherapy, second look surgery is recommended.

Patients undergo radiotherapy daily for 6 weeks beginning after complete resection within 4
weeks of surgery, within 3 weeks of completion of chemotherapy, or within 4 weeks of second
look surgery.

Patients are followed at 6 weeks after radiotherapy, every 2 months for 1 year, every 4
months for 2 years, every 6 months for 2 years, and then annually for 5 years.

PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study within 2-3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically proven nonmetastatic intracranial ependymoma

- Cellular

- Papillary

- Clear cell

- Mixed cell

- Anaplastic

- No myxopapillary ependymoma, subependymoma, or ependymoblastoma

PATIENT CHARACTERISTICS:

Age:

- 3 to 20

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- No hematologic disease that would preclude study participation

Hepatic:

- Not specified

Renal:

- No renal disease that would preclude study participation

Other:

- No concurrent unrelated disease that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy

Endocrine therapy:

- Prior steroids allowed

Radiotherapy:

- No prior radiotherapy

Surgery:

- Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Event-free survival

Safety Issue:

No

Principal Investigator

Richard Grundy, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Birmingham Children's Hospital

Authority:

Unspecified

Study ID:

CDR0000067465

NCT ID:

NCT00004224

Start Date:

January 1999

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • childhood infratentorial ependymoma
  • childhood supratentorial ependymoma
  • newly diagnosed childhood ependymoma
  • Ependymoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

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