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Surgery Plus Radiation Therapy With or Without Chemotherapy in Treating Children With Primitive Neuroectodermal Tumors of the CNS

Primary Purpose

Brain and Central Nervous System Tumors

Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
carboplatin
cyclophosphamide
etoposide
vincristine sulfate
surgical procedure
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 untreated childhood supratentorial primitive neuroectodermal tumor, recurrent childhood supratentorial primitive neuroectodermal tumor

Eligibility Criteria

3 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically proven primitive neuroectodermal tumors of the central nervous system No metastatic disease within or outside the central nervous system Must have survived 1 week following surgery Postoperative CT scan and myelogram required PATIENT CHARACTERISTICS: Age: 3 to 16 Performance status: Not specified Life expectancy: Not specified Hematopoietic: No concurrent hematological disorder Hepatic: Not specified Renal: Renal dysfunction allowed Other: No prior history of malignant disease PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics

Sites / Locations

  • St. James's Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
December 3, 2013
Sponsor
Societe Internationale d'Oncologie Pediatrique
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1. Study Identification

Unique Protocol Identification Number
NCT00003859
Brief Title
Surgery Plus Radiation Therapy With or Without Chemotherapy in Treating Children With Primitive Neuroectodermal Tumors of the CNS
Official Title
Trial of Chemotherapy Utilizing Carboplatin, Vincristine, Cyclophosphamide and Etoposide for the Treatment of Central Nervous System Primitive Neurectodermal Tumors of Childhood
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
April 1992 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Societe Internationale d'Oncologie Pediatrique

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. It is not yet known whether undergoing surgery plus radiation therapy is more effective with or without chemotherapy for primitive neuroectodermal tumors of the CNS. PURPOSE: Randomized phase III trial to compare the effectiveness of surgery plus radiation therapy with or without chemotherapy in treating patients who have primitive neuroectodermal tumors of the CNS.
Detailed Description
OBJECTIVES: I. Determine whether chemotherapy utilizing carboplatin, vincristine, cyclophosphamide, and etoposide improves the prognosis for children with primitive neuroectodermal tumors of the central nervous system when given after surgery and before radiotherapy. II. Assess prospective factors that may determine ultimate prognosis in this patient population. III. Determine the quality of survival of these patients on both treatment regimens. OUTLINE: This is a randomized study. Patients undergo surgical removal of the primary tumor. Following surgery, patients are randomized to receive radiotherapy alone (arm I) or chemotherapy followed by radiotherapy (arm II). Arm I: Patients begin receiving radiotherapy as soon as possible after surgery, within 28 days. Radiotherapy is administered 5 times a week for 6 weeks. Arm II: Within 28 days of surgery, patients receive vincristine IV on days 1, 7, 14, 21, 28, 35, 42, 49, 56, and 63. Carboplatin IV is administered over 1 hour on days 1, 2, 42, and 43. Etoposide IV is administered over 1 hour on days 1-3, 21-23, 42-44, and 63-65. Cyclophosphamide IV is administered over 4 hours on days 21 and 63. As soon as possible after chemotherapy, patients receive radiotherapy as in arm I. Quality of life is assessed every 3 months for the first year and annually thereafter. Patients are followed every 6 weeks for the first year, every 3 months for the second year, every 4 months for the third year, and every 6 months thereafter. PROJECTED ACCRUAL: A total of 230 patients (115 per treatment arm) will be accrued for this study.

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
untreated childhood supratentorial primitive neuroectodermal tumor, recurrent childhood supratentorial primitive neuroectodermal tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Enrollment
230 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
carboplatin
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)
surgical procedure
Intervention Type
Radiation
Intervention Name(s)
radiation therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically proven primitive neuroectodermal tumors of the central nervous system No metastatic disease within or outside the central nervous system Must have survived 1 week following surgery Postoperative CT scan and myelogram required PATIENT CHARACTERISTICS: Age: 3 to 16 Performance status: Not specified Life expectancy: Not specified Hematopoietic: No concurrent hematological disorder Hepatic: Not specified Renal: Renal dysfunction allowed Other: No prior history of malignant disease PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda S. Lashford
Organizational Affiliation
The Christie NHS Foundation Trust
Official's Role
Study Chair
Facility Information:
Facility Name
St. James's Hospital
City
Leeds
State/Province
England
ZIP/Postal Code
LS9 7TF
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
19328574
Citation
Taylor RE, Donachie PH, Weston CL, Robinson KJ, Lucraft H, Saran F, Ellison DW, Ironside J, Walker DA, Pizer BL; Children's Cancer and Leukaemia Group CNS Tumour Division. Impact of radiotherapy parameters on outcome for patients with supratentorial primitive neuro-ectodermal tumours entered into the SIOP/UKCCSG PNET 3 study. Radiother Oncol. 2009 Jul;92(1):83-8. doi: 10.1016/j.radonc.2009.02.017. Epub 2009 Mar 26.
Results Reference
result
PubMed Identifier
17878477
Citation
Bull KS, Spoudeas HA, Yadegarfar G, Kennedy CR; CCLG. Reduction of health status 7 years after addition of chemotherapy to craniospinal irradiation for medulloblastoma: a follow-up study in PNET 3 trial survivors on behalf of the CCLG (formerly UKCCSG). J Clin Oncol. 2007 Sep 20;25(27):4239-45. doi: 10.1200/JCO.2006.08.7684.
Results Reference
result
PubMed Identifier
16258095
Citation
Ellison DW, Onilude OE, Lindsey JC, Lusher ME, Weston CL, Taylor RE, Pearson AD, Clifford SC; United Kingdom Children's Cancer Study Group Brain Tumour Committee. beta-Catenin status predicts a favorable outcome in childhood medulloblastoma: the United Kingdom Children's Cancer Study Group Brain Tumour Committee. J Clin Oncol. 2005 Nov 1;23(31):7951-7. doi: 10.1200/JCO.2005.01.5479.
Results Reference
result
PubMed Identifier
15328187
Citation
Lamont JM, McManamy CS, Pearson AD, Clifford SC, Ellison DW. Combined histopathological and molecular cytogenetic stratification of medulloblastoma patients. Clin Cancer Res. 2004 Aug 15;10(16):5482-93. doi: 10.1158/1078-0432.CCR-03-0721.
Results Reference
result
PubMed Identifier
15001263
Citation
Taylor RE, Bailey CC, Robinson KJ, Weston CL, Ellison D, Ironside J, Lucraft H, Gilbertson R, Tait DM, Saran F, Walker DA, Pizer BL, Lashford LS; United Kingdom Children's Cancer Study Group Brain Tumour Committee; International Society of Paediatric Oncology. Impact of radiotherapy parameters on outcome in the International Society of Paediatric Oncology/United Kingdom Children's Cancer Study Group PNET-3 study of preradiotherapy chemotherapy for M0-M1 medulloblastoma. Int J Radiat Oncol Biol Phys. 2004 Mar 15;58(4):1184-93. doi: 10.1016/j.ijrobp.2003.08.010.
Results Reference
result
PubMed Identifier
12697884
Citation
Taylor RE, Bailey CC, Robinson K, Weston CL, Ellison D, Ironside J, Lucraft H, Gilbertson R, Tait DM, Walker DA, Pizer BL, Imeson J, Lashford LS; International Society of Paediatric Oncology; United Kingdom Children's Cancer Study Group. Results of a randomized study of preradiation chemotherapy versus radiotherapy alone for nonmetastatic medulloblastoma: The International Society of Paediatric Oncology/United Kingdom Children's Cancer Study Group PNET-3 Study. J Clin Oncol. 2003 Apr 15;21(8):1581-91. doi: 10.1200/JCO.2003.05.116.
Results Reference
result

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Surgery Plus Radiation Therapy With or Without Chemotherapy in Treating Children With Primitive Neuroectodermal Tumors of the CNS

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