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European Low and Intermediate Risk Neuroblastoma Protocol


Phase 3
90 Days
18 Years
Open (Enrolling)
Both
LOW AND INTERMEDIATE PAEDIATRIC NEUROBLASTOMA AND NEONATAL SUPRARENAL MASSES

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Trial Information

European Low and Intermediate Risk Neuroblastoma Protocol


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

Inclusion Criteria


1. LOW RISK STUDY

Inclusion criteria for the whole low risk group:

- informed consent and follow-up warranted; group assignment completed within 6
weeks from diagnosis; no prior chemotherapy or radiotherapy

- Biopsy proven neuroblastoma

- Tumour genomic profile obtained in a NRL according to guidelines

- MYCN non-amplified

Exclusion criteria for the whole low risk group:

* Diagnosis of ganglioneuroma or ganglioneuroblastoma intermixed INRG Stage L2

Inclusion criteria:

*age ≤ 18 months

Exclusion criteria:

- any metastatic site

- MYCN amplification

- age > 18 months INRG Stage Ms

Inclusion criteria:

* age ≤ 12 months

Exclusion criteria:

- bone, pleura/lung and/or CNS metastasis

- MYCN amplification

- age > 12 months

2. INTERMEDIATE RISK STUDY

Inclusion criteria for the whole intermediate risk group:

- informed consent and follow-up warranted; group assignment completed within 6
weeks from diagnosis; no prior chemotherapy or radiotherapy

- Tumour material available for biological studies according to guidelines

- Biopsy proven neuroblastoma confirmed in a National Reference Laboratory (NRL)

Exclusion criteria for the whole intermediate risk group:

* Diagnosis of ganglioneuroma or ganglioneuroblastoma intermixed

INRG Stage L1 and INSS stage 1:

Inclusion criteria:

* MYCN amplified

Exclusion criteria:

- MYCN non-amplified

- INSS stages 2, 3, 4, 4s

INRG Stage L2:

Inclusion criteria:

- Histology: differentiating, poorly differentiated, undifferentiated
neuroblastoma or ganglioneuroblastoma nodular

- MYCN non-amplified

- age >18 months

Exclusion criteria:

- neuroblastoma NOS

- MYCN amplification.

- age ≤ 18 months

INRG Stage M:

Inclusion criteria:

- Any histology

- MYCN non-amplified

- age ≤ 12 months

Exclusion criteria:

- MYCN amplification

- age > 12 months

3. NEONATAL SUPRARENAL MASSES

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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Primary aim for Low Risk Neuroblastoma

Outcome Description:

To demonstrate through a randomisation between observation and chemotherapy that you can safely reduce treatment in a subgroup of L2 low risk patients (those without life threatening symptoms (LTS) and without any segmental chromosomal changes (SCA), i.e. study group 1) by giving less treatment than has been given historically while maintaining an excellent OS of 100%.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Adela Cañete, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Hospital Universitari i Politècnic La Fe, Valencia, Spain

Authority:

Spain: Spanish Agency of Medicines

Study ID:

LINES

NCT ID:

NCT01728155

Start Date:

December 2011

Completion Date:

December 2026

Related Keywords:

  • LOW AND INTERMEDIATE PAEDIATRIC NEUROBLASTOMA AND NEONATAL SUPRARENAL MASSES
  • NEUROBLASTOMA, LOW RISK, INTERMEDIATE RISK
  • Neuroblastoma

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