NB2004 Trial Protocol for Risk Adapted Treatment of Children with Neuroblastoma

• Register: German Clinical Trials Register
• Last refreshed on: 27 May 2024
• Main ID: DRKS00001038
• Date of registration: 02/05/2012
• Prospective Registration: No
• Primary sponsor: Universitätsklinik Köln Pädiatrische Onkologie und Hämatologie
• Public title: NB2004 Trial Protocol for Risk Adapted Treatment of Children with Neuroblastoma
• Scientific title: NB2004 Trial Protocol for Risk Adapted Treatment of Children with Neuroblastoma - NB2004
• Date of first enrolment: 01/10/2004
• Target sample size: 800
• Recruitment status: Recruiting
• URL: http://drks.de/search/en/trial/DRKS00001038
• Study type: interventional
• Study design: Allocation: Randomized controlled study; Masking: Open (masking not used); Control: active; Assignment: parallel; Study design purpose: treatment
• Phase: 4

Countries of recruitment

Germany, Switzerland

Contacts

• Name: Frank Berthold
• Affiliation: Universitätsklinik Köln Pädiatrische Onkologie und Hämatologie

• Name: Frank Berthold
• Affiliation: Universitätsklinik Köln Pädiatrische Onkologie und Hämatologie

Key inclusion & exclusion criteria

Inclusion criteria: Diagnosis of neuroblastoma by histology using tumor tissue or as evidenced by the
presence of distinct neuroblastoma cells in the bone marrow AND elevated
catecholamine metabolites (i.e., homovanillic acid [HVA] and vanillylmandelic acid
[VMA]) in blood or urine
- Newly diagnosed disease (for patients in the low-risk group)
- Diagnosis from tumor tissue (for patients in the medium-risk group)
- Meets criteria for 1 of the following risk groups:

Low-risk group:
- No MYCN amplification AND meets 1 of the following criteria:
- Stage 1 disease
- Stage 2 disease with no chromosome 1p deletion or imbalance
- Stage 3 disease with no chromosome 1p deletion or imbalance (for
patients < 2 years of age)
- Stage 4S disease (for patients < 1 year of age)

Medium-risk group:
- No MYCN amplification AND meets 1 of the following criteria:
- Stage 2 disease with chromosome 1p deletion or imbalance
- Stage 3 disease with chromosome 1p deletion or imbalance
- Any chromosome 1p status (for patients = 2 years of age)
- Stage 4 disease (for patients < 1 year of age)

High-risk group, meeting 1 of the following criteria:

- Any stage disease with MYCN amplification
- Any MYCN status (for patients = 1 year of age)

PATIENT CHARACTERISTICS:

- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
Exclusion criteria: - Prior nephrectomy or other mutilating surgery as initial surgery (for patients in
the low-risk group)

- Other concurrent anticancer therapy

Age minimum: None
Age maximum: 21 Years
Gender: All

Health Condition(s) or Problem(s) studied

Adrenal gland, unspecified

C74.9

C74.9

Intervention(s)

Group 1: Observational Group: Doxorubicine, Vincristine, Cyclophosphamide
Group 2: Middle Risk Group: Cisplatine, Etoposide, Vindesine, Dacarbacin, Vincristine, Ifosfamide, Cyclophosphamid, radiation therapy
Group 3: High Risk Group: Topotecan, Cyclophosphamide, Etoposide, radiation therapy

Primary Outcome(s)

Event-free survival (EFS) [Time Frame: No]
Locoregional EFS [Time Frame: No]

Secondary Outcome(s)

Activity and whole body dose of radiotherapy [Time Frame: No]
Acute and late side effects of external-beam radiotherapy (medium-risk group [MRG] and high-risk group [HRG]) [Time Frame: Yes]
Best status of the primary tumor within the first 12 months (LRG) [Time Frame: No]
Comparison of the extent of best surgery during protocol treatment (incomplete resection vs macroscopic complete resection) [Time Frame: No]
Comparison of the extent of initial surgery (incomplete resection vs macroscopic complete resection) (LRG) [Time Frame: No]
Disease progression and symptoms controlled after the first, second, third, and fourth N4 course (LRG) [Time Frame: No]
Disease progression and symptoms not controlled after four N4 courses (LRG) [Time Frame: No]
Early response after 2 courses of induction therapy (N5 and N6 or two courses of N8) (HRG) [Time Frame: No]
Frequency of grade 3 or 4 toxicity observed during the last 6 courses of induction therapy (3 courses of N5 and N6) (HRG) [Time Frame: Yes]
Grade of toxicity observed during induction therapy course 1 (N5 or N8) (HRG) [Time Frame: Yes]
Grade of toxicity observed during induction therapy course 2 (N6 or N8) (HRG) [Time Frame: Yes]
Overall survival [Time Frame: No]
Response to induction therapy prior to conditioning therapy or after 280 days (HRG) [Time Frame: No]
Status of chromosome 1p (unblinded) and status of chromosome 11q (blinded) [Time Frame: No]
Status of the primary tumor 12 months after diagnosis (LRG) [Time Frame: No]
Surgery-related complications (i.e., bleeding, infection, intestinal obstruction, or other) [Time Frame: No]
Time from diagnosis to transition to stage 4 disease, to death from disease, or to the last follow-up (if no transition to stage 4 disease is observed) [Time Frame: No]
Time to no evidence of disease (in patients in the LRG with stage 4S disease) [Time Frame: No]
Time to the beginning of primary tumor regression (in patients in the low-risk group [LRG]) [Time Frame: No]
Time to the normalization of tumor markers HVA and VMA in urine [Time Frame: No]
Transition to stage 4 disease at any time (LRG) [Time Frame: No]

Secondary ID(s)

UKF000350

NCT00410631

Source(s) of Monetary Support

Geschäftsführung der Ge­sell­schaft für Päd­ia­tri­sche On­ko­lo­gie und Hä­ma­to­lo­gie (GPOH)

Ethics review

Status: Approved
Approval date: 13/09/2004
Contact:

[e-mail]

Ethikkommission der Medizinischen Fakultät der Universität zu Köln

[phone]

[e-mail]

Results

• URL: http://drks.de/search/en/trial/DRKS00001038#studyResults