Brain and Central Nervous System TumorsPhase 2NCT00004224
Combination Chemotherapy Followed by Radiation Therapy in Treating Children With Localized Ependymoma
A Phase 2 study testing cyclophosphamide, etoposide and vincristine sulfate in people with Brain and Central Nervous System Tumors, run by Societe Internationale d'Oncologie Pediatrique at 7 sites in 7 countries.
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. Combining more than one drug and combining chemotherapy with radiation therapy may kill more tumor cells. Read more about this study
- Who is it for?
- Ages 3 to 20 years
- Conditions the study is for
- Brain and Central Nervous System Tumors
- What is being tested?
- cyclophosphamide, etoposide and vincristine sulfate
- Type of treatment
- Surgery or procedure
- How many people
- 65 participants
- Where
- 7 sitesin 7 countries
- Study dates
- Jan 1999to Mar 2008
- Phase
- Phase 2
- 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 20 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Trial locations and contacts
7 sites in 7 countries.
7 sites in 7 countries
Argentina1 site
Fundacion para la Lucha contra las Enfermedades Neurologicas de la Infancia
Buenos Aires, Buenos Aires, 1428
Netherlands1 site
Erasmus MC - Sophia Children's Hospital
Rotterdam, 3015 GJ
United Kingdom1 site
Birmingham Children's Hospital
Birmingham, England, B4 6NH
About this study
Official title: SIOP Study of Combined Modality Treatment in Childhood Ependymoma
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.
Read the 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.
- Conditions
- Brain and Central Nervous System Tumors
- Being tested
- cyclophosphamide, etoposide, vincristine sulfate, adjuvant therapy, conventional surgery
- Keywords
- childhood infratentorial ependymoma, childhood supratentorial ependymoma, newly diagnosed childhood ependymoma
- 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.
cyclophosphamideDrug
etoposideDrug
adjuvant therapyProcedure or surgery
conventional surgeryProcedure or surgery
radiation therapyRadiation
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival
Overall survival
Surgical operability
Response rate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startJan 1999
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Societe Internationale d'Oncologie Pediatrique
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Cancer and Leukaemia Group, Italian Association for Pediatric Hematology Oncology
- Investigators
- Richard Grundy, MD, PhD, Study chair, Birmingham Children's HospitalMaura Massimino, MD, Study chair, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004224
- Sponsor's protocol ID
- CDR0000067465
- Other IDs
- SIOP-EPENDYMOMA-99, AIEOP-EPENDYMOMA-99, CCLG-EPENDYMOMA-99, EU-99001
- Status last verified
- Apr 2008
- First submitted
- 28 Jan 2000
- Last updated
- 26 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SIOP Study of Combined Modality Treatment in Childhood Ependymoma
- ClinicalTrials.gov ID
- NCT00004224
- Acronym / sponsor ID
- CDR0000067465
- Conditions
- Brain and Central Nervous System Tumors
- Keywords
- childhood infratentorial ependymoma, childhood supratentorial ependymoma, newly diagnosed childhood ependymoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Societe Internationale d'Oncologie PediatriqueUniversity, hospital or other
- Collaborators
- Children's Cancer and Leukaemia Group, Italian Association for Pediatric Hematology Oncology
- Study start
- Jan 1999
- Study completion
- Mar 2008 (actual)
- First posted
- 27 Jan 2003 (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. 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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 3 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
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 |
|---|---|---|
| cyclophosphamide | Drug | – |
| etoposide | Drug | – |
| vincristine sulfate | Drug | – |
| adjuvant therapy | Procedure or surgery | – |
| conventional surgery | Procedure or surgery | – |
| radiation therapy | Radiation | – |
Primary outcome
Event-free survival
Overall survival
Surgical operability
Response rate
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 26 Aug 2013.
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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.
Richard Grundy, MD, PhD study chair
Birmingham Children's Hospital
Maura Massimino, MD study chair
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
7 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cyclophosphamide, etoposide and vincristine sulfate in people with Brain and Central Nervous System Tumors, run by Societe Internationale d'Oncologie Pediatrique at 7 sites in 7 countries.
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 26 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Argentina, Canada, Italy, Netherlands, Spain and 2 more countries. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
What does the primary outcome measure?
Event-free survival. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Aug 2013.