Clinical trial NCT00004224: Combination Chemotherapy Followed by Radiation Therapy in Treating Children With Localized Ependymoma
Official title: SIOP Study of Combined Modality Treatment in Childhood Ependymoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Brain and Central Nervous System Tumors
Keywords: childhood infratentorial ependymoma
childhood supratentorial ependymoma
newly diagnosed childhood ependymoma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
Collaborators: name: Children's Cancer and Leukaemia Group
name: Italian Association for Pediatric Hematology Oncology
First posted: 2003-01-27
Enrollment: 65
Sex: ALL
Minimum age (years): 3
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Event-free survival
measure: Overall survival
measure: Surgical operability
measure: Response rate
Secondary outcomes:
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Fundacion para la Lucha contra las Enfermedades Neurologicas de la Infancia
city: Toronto
country: Canada
facility: Hospital for Sick Children
state: Ontario
city: Milan
country: Italy
facility: Fondazione Istituto Nazionale dei Tumori
city: Rotterdam
country: Netherlands
facility: Erasmus MC - Sophia Children's Hospital
city: Vizcaya
country: Spain
facility: Hospital Des Cruces
city: Gothenburg
country: Sweden
facility: Ostra Sjukhuset
city: Birmingham
country: United Kingdom
facility: Birmingham Children's Hospital
state: England
Study officials:
affiliation: Birmingham Children's Hospital
name: Richard Grundy, MD, PhD
role: STUDY_CHAIR
affiliation: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
name: Maura Massimino, MD
role: STUDY_CHAIR
References: