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A study for all children and adolescents with a low grade glioma.


- candidate number12232
- NTR NumberNTR3394
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-apr-2012
- Secondary IDs2005-005377-29 EudraCT
- Public TitleA study for all children and adolescents with a low grade glioma.
- Scientific TitleCooperative multicenter Study for Children and Adolescents with Low Grade Glioma.
- ACRONYMSIOP-LGG-2004
- hypothesisThe goal of this study is:
1. To offer a uniform, standardized concept for the treatment of children and adolescents affected by low grade glioma;
2. To improve progression free survival following non-surgical therapy for children without NFI with low grade glioma (incl. randomisation standard vs intensified induction therapy);
3. To investigate standardized treatment recommendations for non-surgical therapy for the study group of children with NFI and low grade glioma;
4. To reduce the rate and intensity of possible late effects of therapy.
- Healt Condition(s) or Problem(s) studiedLow-grade glioma
- Inclusion criteria1. Age: Children and adolescents up to age 16 years;
2. Histology: Glioma of low grade malignancy ( ICD O-Codes: 9421/1, 9384/1, 9413/0, 9412/1, 9505/1, 9424/3, 9450/3, 9382/3, 9400/3, 9420/3, 9410/3, 9411/3);
3. Primary tumor localization: Intracranial and spinal cord;
4. Dissemination: Children presenting with disseminated low grade glioma will be eligible for the study;
5. Associated conditions: Children are eligible for the trial regardless of the presence of associated genetic disease;
6. Primary tumor diagnosis: The tumor should not be pretreated with chemotherapy or radiotherapy;
7. Informed consent: The patient and/or his legal guardian ( parents ) have to have declared their written informed consent to the study.

Within the randomized part of the study all histologies will be randomized, since up to now there are no data to exclude any of the subgroups, e.g. children with oligodendroglioma, from this study.
Specific neuroradiological criteria may allow to diagnose a low grade chiasmatic-hypothalamic tumor without biopsy.
- Exclusion criteria1. Primary tumor localization: Diffuse intrinsic tumors of the pons, even if histologically an Astrocytoma II° is diagnosed. Exception: pontine glioma II° in NF I patients may be entered into the study;
2. Special diagnosis: Patients presenting with rare intracranial neoplasms of low grade malignancy, but non-glial origin. 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 on the SIOP-CPT-study;
3. 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;
4. Preexisting impairments of health status, making the conduct of the study impossible or ethically unwise;
5. Evidence of pregnancy or lactation period.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupFactorial
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 23-mei-2008
- planned closingdate1-jan-2014
- Target number of participants100
- InterventionsFollowing complete resection patients will only be observed, as will be patients without symptoms or progression after incomplete resection or clinical diagnosis. Non-surgical therapy will be instituted at the presence of defined indications following incomplete resection, non-resectable relapse or progression of an unresectable tumor.
Older children (>= 8 years) receive primary radiotherapy. Modern planning and treatment techniques shall reduce long term side effects upon surrounding tissues and organs at risk. At the presence of specific conditions these children may receive chemotherapy as well. The indication for interstitial radiotherapy is not age restricted. Younger children (< 8 years) receive primary chemotherapy. Children affected by Neurofibromatosis NF I shall be treated with chemotherapy at all ages. The duration of chemotherapy is 18 months. Children without NF I (stratified for age and tumor localization) will be randomized to receive standard induction with Vincristin and Carboplatin or intensified induction with Vincristin, Carboplatin and Etoposide, to test, if there is a difference in progression free survival. Additionally the distribution of tumor response at week 24 shall be investigated. Consolidation consists of ten 6-week cycles of Vincristin/Carboplatin therapy.
- Primary outcomeProgression Free Survival.
- Secondary outcome1. Overall survival;
2. Assessment of integral dose to tumor and normal tissue and evaluation on the impact on long – term toxicity;
3. Assessment of tumor response to radiotherapy by imaging and clinical investigations;
4. Assessment of progression-free and overall survival, acute and long-term toxicity of crnio-spinal irradiation in metastatic disease.
- Timepoints1. PFSr: Progression free survival measured from the time of randomization: Time from randomization up to an event: Definition of event:
A. Death (for all reasons);
B. Progression of a residual tumor;
C. Relapse following previous complete remission;
D. Appearance of new or progression of existing metastasis.
2. Radiological response measured at week 24: Complete, partial, objective responses and stable disease will be considered positive responses in this protocol;
3. PFSd: Progression free survival measured from the time of diagnosis: Time from diagnosis up to an event (definitions of event see 1.);
4. EFSr: Event free survival measured from the time of randomization: Time from randomization up to an event. Definition of event:
A. Death (for all reasons);
B. Progression of a residual tumor;
C. Relapse following previous complete remission;
D. Appearance of new or progression of existing metastasis;
E. Severe adverse event / toxicity (not counting Carboplatin hypersensitivity and toxicity of regular protocol application);
F. Appearance of secondary malignant neoplasm.
5. EFSd: Event free survival measured from the time of diagnosis: Time from diagnosis up to an event. (definition of event: see 4.);
6. OSr: Overall survival measured from the time of randomization: Interval starting with the day of randomization and ending with the death of the patient independently of its cause;
7. OSd: Overall survival measured from the time of diagnosis: Interval starting with the day of diagnosis and ending with the death of the patient independently of its cause.
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES C.M. Damen-Korbijn
- CONTACT for SCIENTIFIC QUERIESDr. A.Y.N. Schouten-van Meeteren
- Sponsor/Initiator Dutch Childhood Oncology Group (DCOG), SIOP
- Funding
(Source(s) of Monetary or Material Support)
Dutch Childhood Oncology Group (DCOG)
- PublicationsN/A
- Brief summaryThe study SIOP-LGG 2004 offers a common therapy strategy for all children and adolescents with a histologically ( WHO criteria ) or radiologically confirmed low grade glioma. Following complete resection patients will only be observed, as will be patients without symptoms or progression after incomplete resection or clinical diagnosis. Non-surgical therapy will be instituted at the presence of defined indications following incomplete resection, non-resectable relapse or progression of an unresectable tumor. Older children (³ 8 years) receive primary radiotherapy. Modern planning and treatment techniques shall reduce long term side effects upon surrounding tissues and organs at risk. At the presence of specific conditions these children may receive chemotherapy as well. The indication for interstitial radiotherapy is not age restricted. Younger children (< 8 years) receive primary chemotherapy. Children affected by Neurofibromatosis NF I shall be treated with chemotherapy at all ages. The duration of chemotherapy is 18 months. Children without NF I (stratified for age and tumor localization) will be randomized to receive standard induction with Vincristin and Carboplatin or intensified induction with Vincristin, Carboplatin and Etoposide, to test, if there is a difference in progression free survival. Additionally the distribution of tumor response at week 24 shall be investigated. Consolidation consists of ten 6-week cycles of Vincristin/Carboplatin therapy. For all children overall survival, progression free and event free survival will be calculated. The influence of clinical and histologic findings upon these parameters will be investigated. The extent of late effects of primary tumor and therapy shall be documented prospectively.
- Main changes (audit trail)
- RECORD11-apr-2012 - 4-mei-2012


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