Brain and Central Nervous System TumorsPhase 3NCT00003859
Surgery Plus Radiation Therapy With or Without Chemotherapy in Treating Children With Primitive Neuroectodermal Tumors of the CNS
A Phase 3 study testing carboplatin, cyclophosphamide and etoposide in people with Brain and Central Nervous System Tumors, run by Societe Internationale d'Oncologie Pediatrique at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 3 to 16 years
- Conditions the study is for
- Brain and Central Nervous System Tumors
- What is being tested?
- carboplatin, cyclophosphamide and etoposide
- Type of treatment
- Surgery or procedure
- How many people
- 230 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 1992to Apr 2003
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 16 years
- All sexes
- No healthy volunteers
- Child
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Trial of Chemotherapy Utilizing Carboplatin, Vincristine, Cyclophosphamide and Etoposide for the Treatment of Central Nervous System Primitive Neurectodermal Tumors of Childhood
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.
Read the 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.
- Conditions
- Brain and Central Nervous System Tumors
- Being tested
- carboplatin, cyclophosphamide, etoposide, vincristine sulfate, surgical procedure
- Keywords
- untreated childhood supratentorial primitive neuroectodermal tumor, recurrent childhood supratentorial primitive neuroectodermal tumor
- Medical subject headings
- Central Nervous System Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carboplatinDrug
cyclophosphamideDrug
etoposideDrug
surgical procedureProcedure or surgery
radiation therapyRadiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2004 (estimated)
- Study startApr 1992
- Study completionApr 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Brain and Central Nervous System TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Societe Internationale d'Oncologie Pediatrique
- Sponsor type
- University, hospital or other
- Investigators
- Linda S. Lashford, Study chair, The Christie NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003859
- Sponsor's protocol ID
- CDR0000067022
- Other IDs
- SIOP-PNET-III, EU-99003, UKCCSG-9102
- Status last verified
- Apr 2009
- First submitted
- 1 Nov 1999
- Last updated
- 4 Dec 2013
- Results posted
- No
Publications
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.
PubMed 19328574Bull 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.
PubMed 17878477Ellison 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.
PubMed 16258095Lamont 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.
PubMed 15328187Taylor 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.
PubMed 15001263Taylor 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.
PubMed 12697884
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Chemotherapy Utilizing Carboplatin, Vincristine, Cyclophosphamide and Etoposide for the Treatment of Central Nervous System Primitive Neurectodermal Tumors of Childhood
- ClinicalTrials.gov ID
- NCT00003859
- Acronym / sponsor ID
- CDR0000067022
- Conditions
- Brain and Central Nervous System Tumors
- Keywords
- untreated childhood supratentorial primitive neuroectodermal tumor, recurrent childhood supratentorial primitive neuroectodermal tumor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Societe Internationale d'Oncologie PediatriqueUniversity, hospital or other
- Study start
- Apr 1992
- Study completion
- Apr 2003 (actual)
- First posted
- 9 Jun 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 3 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| carboplatin | Drug | – |
| cyclophosphamide | Drug | – |
| etoposide | Drug | – |
| vincristine sulfate | Drug | – |
| surgical procedure | Procedure or surgery | – |
| radiation therapy | Radiation | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2013.
- Results publication: PubMed 19328574Taylor 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 publication: PubMed 17878477Bull 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 publication: PubMed 16258095Ellison 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 publication: PubMed 15328187Lamont 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 publication: PubMed 15001263Taylor 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 publication: PubMed 12697884Taylor 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda S. Lashford study chair
The Christie NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing carboplatin, cyclophosphamide and etoposide in people with Brain and Central Nervous System Tumors, run by Societe Internationale d'Oncologie Pediatrique at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00003859, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2013.