Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Active 3 to 20 Other SIOP-EPENDYMOMA-99 AIEOP-EPENDYMOMA-99, CCLG-EPENDYMOMA-99, EU-99001, NCT00004224

Objectives

1. 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.
2. Determine the response rate in these patients to this regimen.

Entry Criteria

Disease Characteristics:

• Histologically proven nonmetastatic intracranial ependymoma
  • Cellular
  • Papillary
  • Clear cell
  • Mixed cell
  • Anaplastic



• No myxopapillary ependymoma, subependymoma, or ependymoblastoma

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

• Prior steroids allowed

Radiotherapy:

• No prior radiotherapy

Surgery:

• Not specified

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

Expected Enrollment

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

Outcomes

Event-free survival
Overall survival
Surgical operability
Response rate

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.

Trial Contact Information

Trial Lead Organizations

Societe Internationale d'Oncologie Pediatrique

Richard Grundy, MD, PhD, Protocol chair		Ph: 44-121-333-8234 Email: richard.grundy@nottingham.ac.uk

Children's Cancer and Leukaemia Group

Richard Grundy, MD, PhD, Protocol chair		Ph: 44-121-333-8234 Email: richard.grundy@nottingham.ac.uk

Associazone Italiana Ematologia Oncologia Pediatrica

Maura Massimino, MD, Protocol chair		Ph: 39-02-239-02-593 Email: maura.massimino@istitutotumori.mi.it

Argentina
Buenos Aires
	Buenos Aires
	Fundacion para la Lucha contra las Enfermedades Neurologicas de la Infancia
		Blanca Diez, MD	Ph:  54-11-5777-3200
			Email: bdiez@fleni.org.ar
Canada
Ontario
	Toronto
	Hospital for Sick Children
		Eric Bouffet, MD, MRCP	Ph:  416-813-7457
			Email: eric.bouffet@sickkids.ca
Italy
	Milan
	Fondazione Istituto Nazionale dei Tumori
		Maura Massimino, MD	Ph:  39-02-239-02-593
			Email: maura.massimino@istitutotumori.mi.it
Netherlands
	Rotterdam
	Erasmus MC - Sophia Children's Hospital
		R. Reddingius, MD, PhD	Ph:  31-10-463-6363
Spain
	Vizcaya
	Hospital Des Cruces
		Aurora Navajas	Ph:  34-94-600-6000
Sweden
	Gothenburg
	Ostra Sjukhuset
		Brigitta Lannering, MD, PhD	Ph:  46-31-343-5224
United Kingdom
England
	Birmingham
	Birmingham Children's Hospital
		Richard Grundy, MD, PhD	Ph:  44-121-333-8234
			Email: richard.grundy@nottingham.ac.uk

Registry Information
Official Title		SIOP Study of Combined Modality Treatment in Childhood Ependymoma
Trial Start Date		1999-01-14
Registered in ClinicalTrials.gov		NCT00004224
Date Submitted to PDQ		1999-07-17
Information Last Verified		2008-04-27

Back to Top