Primary Central Nervous System NeoplasmsSIOP-LGG-2004NCT00276640
Radiation Therapy or Combination Chemotherapy in Treating Patients With Clinically or Radiologically Progressive Low-Grade Gliomas
A study testing vincristine, carboplatin, vincristine, carboplatin, etoposide and radiation therapy in people with Primary Central Nervous System Neoplasms, run by Societe Internationale d'Oncologie Pediatrique at 13 sites in 12 countries.
Trial summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Primary Central Nervous System Neoplasms
- What is being tested?
- vincristine, carboplatin, vincristine, carboplatin, etoposide and radiation therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,417 participants
- Where
- 13 sitesin 12 countries
- Study dates
- 1 Apr 2004to 31 May 2017
- Phase
- Interventional
- 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 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age: children and adolescents up to the completion of the 18th year of life.
- Histology: low grade glioma according to ICD O Code Children with chiasmatic-hypothalamic tumors may be eligible without histological diagnosis, if neuroradiologic findings meet unequivocal criteria for the presence of a low grade glioma.
- Primary tumor localization: intracranial and/or spinal cord.
- Dissemination: Children presenting with disseminated low grade glioma will be eligible for the study.
- Associated conditions: Children are eligible for the trial regardless of the presence of associated genetic disease: Neurofibromatosis NF I will be the prominent one, all children with NF I are entered into the study arm III in case of an indication for non-surgical therapy. Other conditions like Tuberous Sclerosis etc. should be registered and their impact on the course of disease and/or therapy be followed.
- Primary tumor diagnosis: The tumor should not be pretreated with chemotherapy or radiotherapy.
- Informed consent: The patient and/or his legal guardian ( parents ) have to have declared their written informed consent to the study.
- Randomization: All eligible patients without Neurofibromatosis NF I receiving chemotherapy as their fist non-surgical therapy are eligible for randomization.
Who cannot join
- Primary tumor localization: diffuse intrinsic tumors of the pons, even if histologically an Astrocytoma I° or II° is diagnosed.
- Exception: pontine glioma II° in NF I patients may be entered into the study.
- Special diagnosis: Patients presenting with rare intracranial neoplasms of low grade malignancy, but non-glial origin may be followed according to the low grade glioma strategy but they are not subject of this therapy trial. Their data may be registered however, to learn about those therapeutic interventions which may prove useful to these patients and to develop separate strategies in the future. Choroid plexus papilloma should be entered into the SIOP-CPT study.
- Pretreatment: Children treated with chemo- or radiotherapy prior to entering the study will be evaluated separately. (Previous treatment with steroids is not considered a chemotherapeutic treatment.)
- Preexisting impairments of health status, making the conduct of the study impossible or ethically unwise.
- Evidence of pregnancy or lactation period.
- Participation in another clinical study: In case the patient participates in another clinical study simultaneously to being enrolled in the study SIOP-LGG 2004, which is not interfering with the present treatment strategy ( e.g. endocrinologic study ), this should be known to the national study chairmen.
- Medication: Concomitant medication for associated or other conditions ( e.g. hormone replacement, anticonvulsants ), not containing cytostatic drugs, should be recorded, but is no exclusion criteria.
Trial locations and contacts
13 sites in 12 countries.
13 sites in 12 countries
United Kingdom2 sites
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, LS9 7TF
Queen's Medical Centre
Nottingham, England, NG7 2UH
Austria1 site
Allg. Krankenhaus der Stadt Wien Universitaets-Kinderklinik
Vienna, 1090
About this study
Official title: Cooperative Multicenter Study for Children and Adolescents With Low Grade Glioma
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This clinical trial is studying giving radiation therapy or combination chemotherapy to see how well it works in treating patients with clinically or radiologically progressive low-grade gliomas.
Read the detailed description
OBJECTIVES:
- Provide a comprehensive treatment strategy for children and adolescents with low-grade glioma of all tumour locations and histologies.
- Provide standardized treatment indication and treatment recommendations for non-surgical therapy in children and adolescents with low grade glioma without and with associated neurofibrosis-type 1 (NF1) at diagnosis or after observation.
- Determine overall, event-free, and progression-free survival.
- Radiotherapy arm: a. Determine progression free survival in older children without NF1 treated with radiotherapy using modern techniques for planning and treatment. b. Determine the reduction of the rate and intensity of possible late effects of therapy to the organs at risk by optimized planning and treatment.
- Chemotherapy arm: a. Determine progression free survival for younger children without NF1 treated with chemotherapy and randomized to either the 2-drug or the 3-drug induction regimen. b. Determine the distribution of response at week 24 (after induction) for younger children without NF1 treated with chemotherapy and randomized to either the 2-drug or the 3-drug induction regimen. c. Determine progression free survival for children with NF1treated with chemotherapy.
- Determine the influence of clinical and histological findings on overall survival, progression-free and event-free survival in these patients.
- Determine prospectively the late effects of tumor and therapy in these patients.
OUTLINE: This is a partially randomized, open-label, multicenter study.
Children with completely resected tumors, incompletely resected tumors, or those with clinically/neuroradiologically diagnosed tumors, who do not have severe symptoms at diagnosis, are only observed during follow-up.
Children with unresectable/incompletely-resectable tumors, or those with relapsed disease and those observed following incomplete initial resection or neuroradiologic diagnosis and clinical and/or neuro-radiologic progression receive non-surgical therapy. This non-surgical therapy is either chemotherapy (for children younger than 8 years and those with neurofibrosis-type 1 [NF1]) or radiotherapy (for children older than 8 years).
- Chemotherapy: Within the chemotherapy arm, patients without NF1 are randomized to receive 1 of 2 induction chemotherapy regimens. Patients with NF1 receive the two-drug induction therapy as in arm I.
- Arm I (two-drug induction therapy [vincristine-carboplatin] ): Patients receive induction therapy comprising vincristine IV on day 1 of weeks 1-10 and weeks 13, 17, and 21 and carboplatin IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 17, and 21.
- Arm II (three-drug induction therapy [vincristine-carboplatin-etoposide]): Patients receive vincristine and carboplatin as in two-drug induction therapy. Patients also receive etoposide IV over 1 hour on days 1-3 of weeks 1, 4, 7, and 10.
Beginning in week 25, all patients in the chemotherapy arm receive consolidation therapy comprising vincristine IV on days 1, 8, and 15 and carboplatin IV over 1 hour on day 1. Treatment repeats every 6 weeks for 9 courses. Patients experiencing disease progression or an allergic reaction to carboplatin receive vincristine IV on days 1, 8, and 15 and either cyclophosphamide IV over 1 hour on day 1 or cisplatin IV over 3 hours on days 1 and 2. Treatment repeats every 6 weeks for 5 courses. All patients in the chemotherapy arm receive a total of 18 months of treatment.
- Radiotherapy: Conventional external beam fractionated radiotherapy is given at standard doses for children receiving radiotherapy. Brachytherapy can be given, if tumors are suitable for this type of treatment.
After completion of study treatment, patients are followed periodically for 10 years.
PROJECTED ACCRUAL: A total of 520 patients will be accrued for the randomized arm of this study.
- Conditions
- Primary Central Nervous System Neoplasms
- Being tested
- vincristine, carboplatin, vincristine, carboplatin, etoposide, radiation therapy
- Keywords
- recurrent childhood brain stem glioma, untreated childhood brain stem glioma, recurrent childhood cerebellar astrocytoma, untreated childhood cerebellar astrocytoma, childhood low-grade cerebral astrocytoma, recurrent childhood cerebral astrocytoma, childhood oligodendroglioma, recurrent childhood visual pathway and hypothalamic glioma, untreated childhood visual pathway and hypothalamic glioma, childhood spinal cord neoplasm
- Medical subject headings
- Central Nervous System Neoplasms, Astrocytoma, Oligodendroglioma, Optic Nerve Glioma, Spinal Cord Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vincristine, carboplatinDrug
vincristine: 1,5 mg/m² i.v., week 1,2,3,4,5,6,7,8,9,10,13,17,21
carboplatin: 550 mg/m² i.v., week 1,4,7,10,13,17,21
vincristine, carboplatin, etoposideDrug
vincristine: 1,5 mg/m² i.v., week 1,2,3,4,5,6,7,8,9,10,13,17,21
carboplatin: 550 mg/m² i.v., week 1,4,7,10,13,17,21
etoposide: 100 mg/m² i.v., week 1,4,7,10
radiation therapyRadiation
intracranial tumor site: 30 fractions, dose per fraction: 1.8 Gy, total dose: 54 Gy, duration 6 weeks
spinal tumor site: 28 fractions, dose per fraction: 1.8 Gy, total dose: 50.4 Gy duration 5 1/2 weeks
| Study group | Role | What they receive |
|---|---|---|
| vincristine, carboplatin | Active comparator | standard chemotherapy group Receives: Drug: vincristine, carboplatin |
| vincristine, carboplatin, etoposide | Active comparator | intensified induction chemotherapy group Receives: Drug: vincristine, carboplatin, etoposide |
| radiation | Active comparator | radiation therapy group Receives: Radiation: radiation therapy |
| Control | No intervention | Control group: wait and see strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Measured: week 24, and at 1, 3, and 5 years
Event-free survival
Measured: week 24 and at 1, 3, and 5 years
Overall survival
Measured: week 24 and at 1, 3, and 5 years
Secondary outcomes (1)
Response week 24
radiological response to therapy (chemotherapy or radiation therapy)
Measured: week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2006 (estimated)
- Study start1 Apr 2004
- Primary completion31 Dec 2015
- Study completion31 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Primary Central Nervous System NeoplasmsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,417 participants (actual)
Sponsor and investigators
- Lead sponsor
- Societe Internationale d'Oncologie Pediatrique
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Astrid K. Gnekow, Societe Internationale d'Oncologie Pediatrique
- Investigators
- Astrid Gnekow, Study chair, University Hospital Augsburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00276640
- Sponsor's protocol ID
- CDR0000454506
- Other IDs
- 2005-005377-29, 2005
- Acronym
- SIOP-LGG-2004
- Status last verified
- Apr 2018
- First submitted
- 12 Jan 2006
- Last updated
- 20 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gnekow AK, Walker DA, Kandels D, Picton S, Giorgio Perilongo, Grill J, Stokland T, Sandstrom PE, Warmuth-Metz M, Pietsch T, Giangaspero F, Schmidt R, Faldum A, Kilmartin D, De Paoli A, De Salvo GL; of the Low Grade Glioma Consortium and the participating centers. A European randomised controlled trial of the addition of etoposide to standard vincristine and carboplatin induction as part of an 18-month treatment programme for childhood (</=16 years) low grade glioma - A final report. Eur J Cancer. 2017 Aug;81:206-225. doi: 10.1016/j.ejca.2017.04.019. Epub 2017 Jun 22.
PubMed 28649001Weiss S, Thomale UW, Schulz M, Kandels D, Schuhmann MU, El Damaty A, Krauss J, Driever PH, Witt O, Bison B, Pietsch T, Gnekow A, Simon M. Neurosurgical morbidity in pediatric supratentorial midline low-grade glioma: Results from the German LGG studies. Int J Cancer. 2023 Oct 15;153(8):1487-1500. doi: 10.1002/ijc.34615. Epub 2023 Jun 1.
PubMed 37260252Kandels D, Pietsch T, Bison B, Warmuth-Metz M, Thomale UW, Kortmann RD, Timmermann B, Hernaiz Driever P, Witt O, Schmidt R, Gnekow AK. Loss of efficacy of subsequent nonsurgical therapy after primary treatment failure in pediatric low-grade glioma patients-Report from the German SIOP-LGG 2004 cohort. Int J Cancer. 2020 Dec 15;147(12):3471-3489. doi: 10.1002/ijc.33170. Epub 2020 Jul 11.
PubMed 32580249
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cooperative Multicenter Study for Children and Adolescents With Low Grade Glioma
- ClinicalTrials.gov ID
- NCT00276640
- Acronym / sponsor ID
- SIOP-LGG-2004 / CDR0000454506
- Conditions
- Primary Central Nervous System Neoplasms
- Keywords
- recurrent childhood brain stem glioma, untreated childhood brain stem glioma, recurrent childhood cerebellar astrocytoma, untreated childhood cerebellar astrocytoma, childhood low-grade cerebral astrocytoma, recurrent childhood cerebral astrocytoma, childhood oligodendroglioma, recurrent childhood visual pathway and hypothalamic glioma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,417 participants (actual)
- Lead sponsor
- Societe Internationale d'Oncologie PediatriqueUniversity, hospital or other
- Study start
- 1 Apr 2004 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 31 May 2017 (actual)
- First posted
- 13 Jan 2006 (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: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This clinical trial is studying giving radiation therapy or combination chemotherapy to see how well it works in treating patients with clinically or radiologically progressive low-grade gliomas.
Detailed description
OBJECTIVES:
- Provide a comprehensive treatment strategy for children and adolescents with low-grade glioma of all tumour locations and histologies.
- Provide standardized treatment indication and treatment recommendations for non-surgical therapy in children and adolescents with low grade glioma without and with associated neurofibrosis-type 1 (NF1) at diagnosis or after observation.
- Determine overall, event-free, and progression-free survival.
- Radiotherapy arm: a. Determine progression free survival in older children without NF1 treated with radiotherapy using modern techniques for planning and treatment. b. Determine the reduction of the rate and intensity of possible late effects of therapy to the organs at risk by optimized planning and treatment.
- Chemotherapy arm: a. Determine progression free survival for younger children without NF1 treated with chemotherapy and randomized to either the 2-drug or the 3-drug induction regimen. b. Determine the distribution of response at week 24 (after induction) for younger children without NF1 treated with chemotherapy and randomized to either the 2-drug or the 3-drug induction regimen. c. Determine progression free survival for children with NF1treated with chemotherapy.
- Determine the influence of clinical and histological findings on overall survival, progression-free and event-free survival in these patients.
- Determine prospectively the late effects of tumor and therapy in these patients.
OUTLINE: This is a partially randomized, open-label, multicenter study.
Children with completely resected tumors, incompletely resected tumors, or those with clinically/neuroradiologically diagnosed tumors, who do not have severe symptoms at diagnosis, are only observed during follow-up.
Children with unresectable/incompletely-resectable tumors, or those with relapsed disease and those observed following incomplete initial resection or neuroradiologic diagnosis and clinical and/or neuro-radiologic progression receive non-surgical therapy. This non-surgical therapy is either chemotherapy (for children younger than 8 years and those with neurofibrosis-type 1 [NF1]) or radiotherapy (for children older than 8 years).
- Chemotherapy: Within the chemotherapy arm, patients without NF1 are randomized to receive 1 of 2 induction chemotherapy regimens. Patients with NF1 receive the two-drug induction therapy as in arm I.
- Arm I (two-drug induction therapy [vincristine-carboplatin] ): Patients receive induction therapy comprising vincristine IV on day 1 of weeks 1-10 and weeks 13, 17, and 21 and carboplatin IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 17, and 21.
- Arm II (three-drug induction therapy [vincristine-carboplatin-etoposide]): Patients receive vincristine and carboplatin as in two-drug induction therapy. Patients also receive etoposide IV over 1 hour on days 1-3 of weeks 1, 4, 7, and 10.
Beginning in week 25, all patients in the chemotherapy arm receive consolidation therapy comprising vincristine IV on days 1, 8, and 15 and carboplatin IV over 1 hour on day 1. Treatment repeats every 6 weeks for 9 courses. Patients experiencing disease progression or an allergic reaction to carboplatin receive vincristine IV on days 1, 8, and 15 and either cyclophosphamide IV over 1 hour on day 1 or cisplatin IV over 3 hours on days 1 and 2. Treatment repeats every 6 weeks for 5 courses. All patients in the chemotherapy arm receive a total of 18 months of treatment.
- Radiotherapy: Conventional external beam fractionated radiotherapy is given at standard doses for children receiving radiotherapy. Brachytherapy can be given, if tumors are suitable for this type of treatment.
After completion of study treatment, patients are followed periodically for 10 years.
PROJECTED ACCRUAL: A total of 520 patients will be accrued for the randomized arm of this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| vincristine, carboplatin | Active comparator | Drug: vincristine, carboplatinstandard chemotherapy group |
| vincristine, carboplatin, etoposide | Active comparator | Drug: vincristine, carboplatin, etoposideintensified induction chemotherapy group |
| radiation | Active comparator | Radiation: radiation therapyradiation therapy group |
| Control | No intervention | –Control group: wait and see strategy |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Age: children and adolescents up to the completion of the 18th year of life.
- Histology: low grade glioma according to ICD O Code Children with chiasmatic-hypothalamic tumors may be eligible without histological diagnosis, if neuroradiologic findings meet unequivocal criteria for the presence of a low grade glioma.
- Primary tumor localization: intracranial and/or spinal cord.
- Dissemination: Children presenting with disseminated low grade glioma will be eligible for the study.
- Associated conditions: Children are eligible for the trial regardless of the presence of associated genetic disease: Neurofibromatosis NF I will be the prominent one, all children with NF I are entered into the study arm III in case of an indication for non-surgical therapy. Other conditions like Tuberous Sclerosis etc. should be registered and their impact on the course of disease and/or therapy be followed.
Key exclusion criteria (8 listed)
- Primary tumor localization: diffuse intrinsic tumors of the pons, even if histologically an Astrocytoma I° or II° is diagnosed.
- Exception: pontine glioma II° in NF I patients may be entered into the study.
- Special diagnosis: Patients presenting with rare intracranial neoplasms of low grade malignancy, but non-glial origin may be followed according to the low grade glioma strategy but they are not subject of this therapy trial. Their data may be registered however, to learn about those therapeutic interventions which may prove useful to these patients and to develop separate strategies in the future. Choroid plexus papilloma should be entered into the SIOP-CPT study.
- Pretreatment: Children treated with chemo- or radiotherapy prior to entering the study will be evaluated separately. (Previous treatment with steroids is not considered a chemotherapeutic treatment.)
- Preexisting impairments of health status, making the conduct of the study impossible or ethically unwise.
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 |
|---|---|---|
| vincristine, carboplatinvincristine: 1,5 mg/m² i.v., week 1,2,3,4,5,6,7,8,9,10,13,17,21 carboplatin: 550 mg/m² i.v., week 1,4,7,10,13,17,21 | Drug | vincristine, carboplatin |
| vincristine, carboplatin, etoposidevincristine: 1,5 mg/m² i.v., week 1,2,3,4,5,6,7,8,9,10,13,17,21 carboplatin: 550 mg/m² i.v., week 1,4,7,10,13,17,21 etoposide: 100 mg/m² i.v., week 1,4,7,10 | Drug | vincristine, carboplatin, etoposide |
| radiation therapyintracranial tumor site: 30 fractions, dose per fraction: 1.8 Gy, total dose: 54 Gy, duration 6 weeks spinal tumor site: 28 fractions, dose per fraction: 1.8 Gy, total dose: 50.4 Gy duration 5 1/2 weeks | Radiation | radiation |
Primary outcome
Progression-free survival
Time frame: week 24, and at 1, 3, and 5 years
Event-free survival
Time frame: week 24 and at 1, 3, and 5 years
Overall survival
Time frame: week 24 and at 1, 3, and 5 years
1 secondary outcome
Response week 24
Time frame: week 24
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 20 Apr 2018.
- Results publication: PubMed 28649001Gnekow AK, Walker DA, Kandels D, Picton S, Giorgio Perilongo, Grill J, Stokland T, Sandstrom PE, Warmuth-Metz M, Pietsch T, Giangaspero F, Schmidt R, Faldum A, Kilmartin D, De Paoli A, De Salvo GL; of the Low Grade Glioma Consortium and the participating centers. A European randomised controlled trial of the addition of etoposide to standard vincristine and carboplatin induction as part of an 18-month treatment programme for childhood (</=16 years) low grade glioma - A final report. Eur J Cancer. 2017 Aug;81:206-225. doi: 10.1016/j.ejca.2017.04.019. Epub 2017 Jun 22.
- Derived from this study: PubMed 37260252Weiss S, Thomale UW, Schulz M, Kandels D, Schuhmann MU, El Damaty A, Krauss J, Driever PH, Witt O, Bison B, Pietsch T, Gnekow A, Simon M. Neurosurgical morbidity in pediatric supratentorial midline low-grade glioma: Results from the German LGG studies. Int J Cancer. 2023 Oct 15;153(8):1487-1500. doi: 10.1002/ijc.34615. Epub 2023 Jun 1.
- Derived from this study: PubMed 32580249Kandels D, Pietsch T, Bison B, Warmuth-Metz M, Thomale UW, Kortmann RD, Timmermann B, Hernaiz Driever P, Witt O, Schmidt R, Gnekow AK. Loss of efficacy of subsequent nonsurgical therapy after primary treatment failure in pediatric low-grade glioma patients-Report from the German SIOP-LGG 2004 cohort. Int J Cancer. 2020 Dec 15;147(12):3471-3489. doi: 10.1002/ijc.33170. Epub 2020 Jul 11.
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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.
Astrid Gnekow study chair
University Hospital Augsburg
13 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vincristine, carboplatin, vincristine, carboplatin, etoposide and radiation therapy in people with Primary Central Nervous System Neoplasms, run by Societe Internationale d'Oncologie Pediatrique at 13 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. 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 20 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United Kingdom, Austria, Belgium, Croatia, Denmark and 7 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.
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?
Progression-free survival (time frame: week 24, and at 1, 3, and 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00276640, which also lists 3 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 20 Apr 2018.