European Low and Intermediate Risk Neuroblastoma Protocol

  • STATUS
    Recruiting
  • End date
    Dec 23, 2031
  • participants needed
    685
  • sponsor
    Instituto de Investigacion Sanitaria La Fe
Updated on 23 January 2021
Investigator
Adela Cañete, MD, PhD
Primary Contact
Casa Sollievo della Sofferenza (0.0 mi away) Contact
+79 other location

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 99.1-2 infant neuroblastoma studies where the overall survival was greater than 97%(H. Rubie, JCO).
  • improve the EFS and maintain the OS (overall survival) in L2 and Ms patients with a SCA(Segmental 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 tumours/masses 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

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 and/or 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 tumours/masses 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

Details
Condition LOW AND INTERMEDIATE PAEDIATRIC NEUROBLASTOMA AND NEONATAL SUPRARENAL MASSES
Treatment Chemotherapy
Clinical Study IdentifierNCT01728155
SponsorInstituto de Investigacion Sanitaria La Fe
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age less than or equal to 90 days when the suprarenal mass is discovered
Suprarenal mass detected by ultrasound and/or MRI. The suprarenal mass may be cystic and/or solid, but IT CANNOT REACH THE MIDLINE AND should MEASURE 5 CM AT THE LARGEST DIAMETER
No regional involvement: MRI scan does not show evidence of positive ipsi/contralateral lymph nodes or other spread outside the suprarenal gland
No metastatic involvement
Frozen plasma available
Informed consent
Availability to do the adequate follow-up

Exclusion Criteria

Age older than 90 days
Suprarenal mass bigger than 5 cm
Regional involvement
Metastatic involvement
Inability to undertake mandatory diagnostic studies (biological markers, US, MRI, MIBG)
Follow-up not guaranteed by parents/guardians
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note