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

Primary Purpose

Brain and Central Nervous System Tumors

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
cyclophosphamide
etoposide
vincristine sulfate
adjuvant therapy
conventional surgery
radiation therapy
Sponsored by
Societe Internationale d'Oncologie Pediatrique
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring childhood infratentorial ependymoma, childhood supratentorial ependymoma, newly diagnosed childhood ependymoma

Eligibility Criteria

3 Years - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fundacion para la Lucha contra las Enfermedades Neurologicas de la Infancia
  • Hospital for Sick Children
  • Fondazione Istituto Nazionale dei Tumori
  • Erasmus MC - Sophia Children's Hospital
  • Hospital Des Cruces
  • Ostra Sjukhuset
  • Birmingham Children's Hospital

Outcomes

Primary Outcome Measures

Event-free survival
Overall survival
Surgical operability
Response rate

Secondary Outcome Measures

Full Information

First Posted
January 28, 2000
Last Updated
August 23, 2013
Sponsor
Societe Internationale d'Oncologie Pediatrique
Collaborators
Children's Cancer and Leukaemia Group, Italian Association for Pediatric Hematology Oncology
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1. Study Identification

Unique Protocol Identification Number
NCT00004224
Brief Title
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

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
January 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Societe Internationale d'Oncologie Pediatrique
Collaborators
Children's Cancer and Leukaemia Group, Italian Association for Pediatric Hematology Oncology

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors
Keywords
childhood infratentorial ependymoma, childhood supratentorial ependymoma, newly diagnosed childhood ependymoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
65 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
etoposide
Intervention Type
Drug
Intervention Name(s)
vincristine sulfate
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Event-free survival
Title
Overall survival
Title
Surgical operability
Title
Response rate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Grundy, MD, PhD
Organizational Affiliation
Birmingham Children's Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Maura Massimino, MD
Organizational Affiliation
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Official's Role
Study Chair
Facility Information:
Facility Name
Fundacion para la Lucha contra las Enfermedades Neurologicas de la Infancia
City
Buenos Aires
ZIP/Postal Code
1428
Country
Argentina
Facility Name
Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Facility Name
Fondazione Istituto Nazionale dei Tumori
City
Milan
ZIP/Postal Code
20133
Country
Italy
Facility Name
Erasmus MC - Sophia Children's Hospital
City
Rotterdam
ZIP/Postal Code
3015 GJ
Country
Netherlands
Facility Name
Hospital Des Cruces
City
Vizcaya
ZIP/Postal Code
48
Country
Spain
Facility Name
Ostra Sjukhuset
City
Gothenburg
ZIP/Postal Code
41685
Country
Sweden
Facility Name
Birmingham Children's Hospital
City
Birmingham
State/Province
England
ZIP/Postal Code
B4 6NH
Country
United Kingdom

12. IPD Sharing Statement

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

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