Combination Chemotherapy Followed by Radiation Therapy in Treating Children With Localized Ependymoma

Brain and Central Nervous System Tumors Clinical Trial

Official title:

SIOP Study of Combined Modality Treatment in Childhood Ependymoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004224
• Other study ID #: CDR0000067465
• Secondary ID: SIOP-EPENDYMOMA-
• Status: Completed
• Phase: Phase 2
• First received: January 28, 2000
• Last updated: August 23, 2013
• Start date: January 1999
• Est. completion date: March 2008

Study information

• Verified date: April 2008
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one drug and combining chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying combination chemotherapy and radiation therapy to see how well they work in treating children with localized ependymoma.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 20 Years

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Ependymoma
• Nervous System Neoplasms

Intervention

Drug:
• cyclophosphamide

• etoposide

• vincristine sulfate

Procedure:
• adjuvant therapy

• conventional surgery

Radiation:
• radiation therapy

Locations

Country	Name	City	State
Argentina	Fundacion para la Lucha contra las Enfermedades Neurologicas de la Infancia	Buenos Aires
Canada	Hospital for Sick Children	Toronto	Ontario
Italy	Fondazione Istituto Nazionale dei Tumori	Milan
Netherlands	Erasmus MC - Sophia Children's Hospital	Rotterdam
Spain	Hospital Des Cruces	Vizcaya
Sweden	Ostra Sjukhuset	Gothenburg
United Kingdom	Birmingham Children's Hospital	Birmingham	England

Sponsors (3)

Lead Sponsor	Collaborator
Societe Internationale d'Oncologie Pediatrique	Children's Cancer and Leukaemia Group, Italian Association for Pediatric Hematology Oncology

Countries where clinical trial is conducted

Argentina,  Canada,  Italy,  Netherlands,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event-free survival			No
Primary	Overall survival			No
Primary	Surgical operability			No
Primary	Response rate			No