Ignite Creation Date:
2024-05-06 @ 1:04 AM
Last Modification Date:
2024-10-26 @ 10:59 AM
Study NCT ID:
NCT01728155
Status:
COMPLETED
Last Update Posted:
2023-09-08
First Post:
2012-11-13
Brief Title:
European Low and Intermediate Risk Neuroblastoma Protocol
Sponsor:
Instituto de Investigacion Sanitaria La Fe
Organization:
Instituto de Investigacion Sanitaria La Fe
Study Overview
Official Title:
European Low and Intermediate Risk Neuroblastoma Protocol
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The European study LINES 2009 Low and Intermediate Risk Neuroblastoma European Study groups together in a single protocol the treatment of all patients with non high risk neuroblastoma NB with stratification into two groups low risk and intermediate risk These two separate cohorts are included in one single protocol to enable patient data from these two groups to be entered into a common database as the current prognostic classifications determining treatment may evolve further with subsequent more detailed molecular analysis of the tumours
1 LOW RISK STUDY
The Low Risk Study is proposed in order to
minimise the amount of treatment chemotherapy and surgery for all appropriate low risk patients who in previous studies have been shown to have an excellent long-term outcome as in the SIOPEN 991-2 infant neuroblastoma studies where the overall survival was greater than 97H Rubie JCO
improve the EFS and maintain the OS overall survival in L2 and Ms patients with a SCASegmental Cromosomal Aberration genomic profile tumour presence of any segmental chromosomal change SCA by electively treating these patients with chemotherapy despite the absence of symptoms
2 INTERMEDIATE RISK STUDY
The Intermediate Risk Study is proposed in order to
reduce the amount of chemotherapy for differentiating histology INRG International Neuroblastoma Risk Group stage L2 NB and ganglioneuroblastoma nodular patients who in previous SIOPEN study have been shown to have an excellent long-term outcome
increase the amount of treatment radiotherapy and 13-cis-RA 13-cis-Retinoic Acid for poorly differentiated or undifferentiated histology INRG stage L2 NB or ganglioneuroblastoma nodular patients in order to improve the EFS registered in the previous SIOPEN study
improve the EFS Event Free Survival of MYCN V-Myc myelocytomatosis viral related oncogene NB derived avian amplified INSS International NB Staging System stage 1 NB patients with the introduction of adjuvant treatment
maintain the very good results obtained in previous SIOPEN study for INRG stage M infants with a moderate treatment
NEONATAL SUPRARENAL MASSES
The incidence of suprarenal tumoursmasses has increased in the last decade due to the expanded use of prenatal ultrasonography in routine obstetric care and in the neonatal and early infancy care The differential diagnosis of these masses ranges from benign adrenal haemorrhage to malignant processes neuroblastoma adrenal carcinoma Knowledge on perinatal suprarenal masses although based on a relatively large literature is scattered amongst studies on very few cases with no methodical approach and often short follow up Therefore the optimal management of these masses has not been clearly defined Neuroblastoma at this age is an intriguing entity with a very good prognosis in most cases The SIOPEN Group based on their results in the first multicenter European Trial for infants with neuroblastoma INES and the world-wide experience provided in the literature is launching this European surveillance study Multi-centre non-blinded one armed prospective trial for these masses Treatment Observation
1 LOW RISK STUDY
The Low Risk Study is proposed in order to
minimise the amount of treatment chemotherapy and surgery for all appropriate low risk patients who in previous studies have been shown to have an excellent long-term outcome as in the SIOPEN 991-2 infant neuroblastoma studies where the overall survival was greater than 97H Rubie JCO
improve the EFS and maintain the OS overall survival in L2 and Ms patients with a SCASegmental Cromosomal Aberration genomic profile tumour presence of any segmental chromosomal change SCA by electively treating these patients with chemotherapy despite the absence of symptoms
2 INTERMEDIATE RISK STUDY
The Intermediate Risk Study is proposed in order to
reduce the amount of chemotherapy for differentiating histology INRG International Neuroblastoma Risk Group stage L2 NB and ganglioneuroblastoma nodular patients who in previous SIOPEN study have been shown to have an excellent long-term outcome
increase the amount of treatment radiotherapy and 13-cis-RA 13-cis-Retinoic Acid for poorly differentiated or undifferentiated histology INRG stage L2 NB or ganglioneuroblastoma nodular patients in order to improve the EFS registered in the previous SIOPEN study
improve the EFS Event Free Survival of MYCN V-Myc myelocytomatosis viral related oncogene NB derived avian amplified INSS International NB Staging System stage 1 NB patients with the introduction of adjuvant treatment
maintain the very good results obtained in previous SIOPEN study for INRG stage M infants with a moderate treatment
NEONATAL SUPRARENAL MASSES
The incidence of suprarenal tumoursmasses has increased in the last decade due to the expanded use of prenatal ultrasonography in routine obstetric care and in the neonatal and early infancy care The differential diagnosis of these masses ranges from benign adrenal haemorrhage to malignant processes neuroblastoma adrenal carcinoma Knowledge on perinatal suprarenal masses although based on a relatively large literature is scattered amongst studies on very few cases with no methodical approach and often short follow up Therefore the optimal management of these masses has not been clearly defined Neuroblastoma at this age is an intriguing entity with a very good prognosis in most cases The SIOPEN Group based on their results in the first multicenter European Trial for infants with neuroblastoma INES and the world-wide experience provided in the literature is launching this European surveillance study Multi-centre non-blinded one armed prospective trial for these masses Treatment Observation
Detailed Description:
1 LOW RISK STUDY
The low risk group of patients includes NB patients without MYCN amplification with or without life threatening symptoms in the following clinical situations
Children aged 18 months with localised neuroblastoma associated with image defined risk factors precluding upfront surgery stage INRG L2
Children aged 12 months with disseminated neuroblastoma without bone pleura lung or CNS Central Nervous System disease stage INRG Ms
2 INTERMEDIATE RISK STUDY
The intermediate risk group of patients includes NB patients in the following clinical situations
Children aged 18 months with localised neuroblastoma without MYCN amplification associated with image defined risk factors precluding upfront surgery stage INRG L2
Children aged 12 months with disseminated neuroblastoma involving bone pleura lung andor CNS stage INRG M without MYCN amplification
Children with localised resected NB stage INSS I with MYCN amplification NEONATAL SUPRARENAL MASSES
The incidence of suprarenal tumoursmasses has increased in the last decade due to the expanded use of prenatal ultrasonography in routine obstetric care and in the neonatal and early infancy care The differential diagnosis of these masses ranges from benign adrenal haemorrhage to malignant processes neuroblastoma adrenal carcinoma Knowledge on perinatal suprarenal masses although based on a relatively large literature is scattered amongst studies on very few cases with no methodical approach and often short follow up Therefore the optimal management of these masses has not been clearly defined Neuroblastoma at this age is an intriguing entity with a very good prognosis in most cases The SIOPEN Group based on their results in the first multicenter European Trial for infants with neuroblastoma INES and the world-wide experience provided in the literature is launching this European surveillance study Multi-centre non-blinded one armed prospective trial for these masses Treatment Observation
The low risk group of patients includes NB patients without MYCN amplification with or without life threatening symptoms in the following clinical situations
Children aged 18 months with localised neuroblastoma associated with image defined risk factors precluding upfront surgery stage INRG L2
Children aged 12 months with disseminated neuroblastoma without bone pleura lung or CNS Central Nervous System disease stage INRG Ms
2 INTERMEDIATE RISK STUDY
The intermediate risk group of patients includes NB patients in the following clinical situations
Children aged 18 months with localised neuroblastoma without MYCN amplification associated with image defined risk factors precluding upfront surgery stage INRG L2
Children aged 12 months with disseminated neuroblastoma involving bone pleura lung andor CNS stage INRG M without MYCN amplification
Children with localised resected NB stage INSS I with MYCN amplification NEONATAL SUPRARENAL MASSES
The incidence of suprarenal tumoursmasses has increased in the last decade due to the expanded use of prenatal ultrasonography in routine obstetric care and in the neonatal and early infancy care The differential diagnosis of these masses ranges from benign adrenal haemorrhage to malignant processes neuroblastoma adrenal carcinoma Knowledge on perinatal suprarenal masses although based on a relatively large literature is scattered amongst studies on very few cases with no methodical approach and often short follow up Therefore the optimal management of these masses has not been clearly defined Neuroblastoma at this age is an intriguing entity with a very good prognosis in most cases The SIOPEN Group based on their results in the first multicenter European Trial for infants with neuroblastoma INES and the world-wide experience provided in the literature is launching this European surveillance study Multi-centre non-blinded one armed prospective trial for these masses Treatment Observation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None