AzTrials
AzTrials

NeuroblastomaPhase 3NCT00410631

Observation, Combination Chemotherapy, Radiation Therapy, and/or Autologous Stem Cell Transplant in Treating Young Patients With Neuroblastoma

A Phase 3 study testing filgrastim, carboplatin and cisplatin in people with Neuroblastoma, run by German Society for Pediatric Oncology and Hematology GPOH gGmbH at 80 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Read more about this study

Who is it for?
Ages Up to 21 years
Conditions the study is for
Neuroblastoma
What is being tested?
filgrastim, carboplatin and cisplatin
Type of treatment
Surgery or procedure
How many people
642 participants
Where
80 sitesin 2 countries
Study dates
Oct 2004to Dec 2010
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

DISEASE CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • No prior nephrectomy or other mutilating surgery as initial surgery (for patients in the low-risk group)
  • No other concurrent anticancer therapy

Trial locations and contacts

80 sites in 2 countries.

80 sites in 2 countries

Germany75 sites, 75 recruiting

  • Kinderklinik - Universitaetsklinikum Aachen

    Aachen, D-52074

    R. Mertens, MD, PhD, 49-241-809-222, rmertens@ukaachen.de

    Recruiting

  • Klinikum Augsburg

    Augsburg, DOH-86156

    Astrid Gnekow, 49-821-400-3603

    Recruiting

  • Klinikum am Bamberg

    Bamberg, 96049

    Gloeckel, MD, 49-951-506-0

    Recruiting

  • Klinikum Bayreuth

    Bayreuth, D-95445

    T. Rupprecht, 49-921-400-6202

    Recruiting

  • Helios Klinikum Berlin

    Berlin, D-13125

    L. Wickmann, MD, 49-30-9401-2353, lwickmann@berlin.helios-kliniken.de

    Recruiting

  • Charite University Hospital - Campus Virchow Klinikum

    Berlin, D-13353

    Gunter Henze, 49-30-450-566-004

    Recruiting

  • Evangelisches Krankenhauus Bielfeld

    Biefeld, 33617

    N. Jorch, MD, 49-521-7727-8050

    Recruiting

  • Kinderklinik der Universitaet Bonn

    Bonn, D-53113

    Udo Bode, MD, 49-228-2873-3215, udo.bode@ukb.uni-bonn.de

    Recruiting

  • Staedtisches Klinikum - Howedestrase

    Braunschweig, 38118

    Contact Person, 49-531-595-1222

    Recruiting

  • Klinikum Bremen-Mitte

    Bremen, D-28205

    Arnulf Pekrun, MD, PhD, 49-421-497-3656, arnulf.pekrun@klinikum-bremen-mitte.de

    Recruiting

  • Allgemeinen Krankenhaus Celle Kinderklinik

    Celle, 29223

    Martin Kirschstein, MD, 49-241-809-222, martin.kirschstein@akh-celle.de

    Recruiting

  • Klinikum Chemnitz gGmbH

    Chemnitz, D-09116

    Krause, MD, 49-371-3332-4124

    Recruiting

  • Klinikum Coburg

    Coburg, 96450

    Roland Frank, MD, 49-8561-225-547

    Recruiting

  • Kliniken der Stadt Koeln gGmbH - Kinderkrankenhaus Riehl

    Cologne, D-50735

    Contact Person, 49-221-8907-5243

    Recruiting

  • Children's Hospital

    Cologne, D-50924

    Frank Berthold, MD, 49-221-478-4380, frank.berthold@uk-koeln.de

    Recruiting

  • Carl - Thiem - Klinkum Cottbus

    Cottbus, D-03048

    D Mobius, MD, 49-355-462-336

    Recruiting

  • Vestische Kinderklinik

    Datteln, 45704

    W. Andler, MD, 49-2363-9750, w.andler@kinderklinik-datteln.de

    Recruiting

  • Klinikum Lippe - Detmold

    Detmold, D-32756

    Klaus Wesseler, MD, 49-5231-724-510

    Recruiting

  • Klinikum Dortmund

    Dortmund, D-44137

    Heidi Olscheswski, MD, 49-231-9532-1721

    Recruiting

  • Universitatsklinikum Carl Gustav Carus

    Dresden, D-01307

    M. Suttorp, MD, 49-351-458-5035, meinolf.suttorp@uniklinikum-dresden.de

    Recruiting

  • Klinikum Duisburg

    Duisburg, D-47055

    Ruef, MD, 49-203-733-2421

    Recruiting

  • Universitaets - Frauenklinik, Duesseldorf

    Düsseldorf, D-40225

    Dilloo, MD, 49-211-811-7680

    Recruiting

  • Helios Klinikum Erfurt

    Erfurt, 99089

    Axel Sauerbrey, MD, 49-361-781-3702, asauerbrey@erfurt.helios-kliniken.de

    Recruiting

  • Universitaets - Kinderklinik

    Erlangen, 91054

    W. Holter, MD, 49-9131-853-3118

    Recruiting

  • Universitaetsklinikum Essen

    Essen, D-45147

    Bernhard Kremens, MD, 49-201-723-2453

    Recruiting

  • Klinikum der J.W. Goethe Universitaet

    Frankfurt, D-60590

    Thomas Klingebiel, MD, 49-69-6301-5243, thomas.klingebiel@kgu.de

    Recruiting

  • Universitaetskinderklinik - Universitaetsklinikum Freiburg

    Freiburg im Breisgau, D-79106

    Charlotte Niemeyer, MD, 49-761-270-4552, charlotte.niemeyer@uniklinik-freiburg.de

    Recruiting

  • Kinderklinik

    Giessen, D-35385

    Alfred Reiter, MD, 49-641-994-3400

    Recruiting

  • Universitaetsklinikum Goettingen

    Göttingen, D-37075

    Lothar Schweigerer, MD, 49-551-396-210

    Recruiting

  • Universitats - Kinderklinik

    Greiswald, 17487

    James F. Beck, MD, 49-3834-866-325, beck@uni-greifswald.de

    Recruiting

  • Universitaetsklinikum Halle

    Halle, D-06097

    Dieter Koerholz, MD, 49-345-557-2911

    Recruiting

  • Krankenhaus St. Elisabeth und St. Barbara

    Halle, D-06110

    G. Guenther, MD, 49-345-213-4514

    Recruiting

  • University Medical Center Hamburg - Eppendorf

    Hamburg, D-20246

    Rudolf Erttmann, MD, 49-40-428-034-270, erttmann@uke.uni-hamburg.de

    Recruiting

  • Kinderkrankenhaus auf der Bult

    Hanover, 30173

    U. Hofmann, MD, 49-511-811-5424

    Recruiting

  • Medizinische Hochschule Hannover

    Hanover, D-30625

    Karl Welte, MD, 49-511-532-9123, welte.karl.h@mh-hannover.de

    Recruiting

  • Universitaets-Kinderklinik Heidelberg

    Heidelberg, D-69120

    Andreas E. Kulozik, MD, PhD, 49-6221-562-311, andreas.kulozik@med.uni-heidelberg.de

    Recruiting

  • SLK - Kliniken Heilbronn GmbH - Klinikum am Gesundbrunnen

    Heilbronn, D-74064

    Full, MD, 49-7131-493-702

    Recruiting

  • Gemeinschaftskrankenhaus

    Herdecke, 58313

    Christoph Tautz, MD, 49-233-0620, ctautz@yahoo.de

    Recruiting

  • Universitaetsklinikum des Saarlandes

    Homburg, 66421

    Norbert Graf, 49-6841-162-4000

    Recruiting

  • Universitaets - Kinderklinik

    Jena, D-07440

    Contact Peron, 49-3641-938-270

    Recruiting

  • Universitaets - Kinderklinik

    Jena, D-07745

    Felix Zintl, MD, 49-3641-9300

    Recruiting

  • Staedtisches Klinikum Karlsruhe gGmbH

    Karlsruhe, 76133

    A. Leipold, 49-721-974-3230

    Recruiting

  • Kinderkrankenhaus Park Schoenfeld

    Kassel, D-34121

    M. L. Wright, MD, 49-561-928-5108

    Recruiting

  • Klinikum Kassel

    Kassel, D-34125

    Martina Rodehueser, MD, 49-561-9800

    Recruiting

  • University Hospital Schleswig-Holstein - Kiel Campus

    Kiel, D-24105

    A. Claviez, MD, 49-431-597-1620, a.claviez@pediatrics.uni-kiel.de

    Recruiting

  • Klinikum Kemperhof Koblenz

    Koblenz, D-56065

    M. Rister, MD, 49-261-499-2602

    Recruiting

  • Klinikum Krefeld GmbH

    Krefeld, D-47805

    S. Volpel, MD, 49-2151-322-375

    Recruiting

  • Universitaets - Kinderklinik - Luebeck

    Lübeck, D-23538

    Peter P. Bucsky, MD, 49-451-500-2956, bucsky@paedia.ukl.mu-luebeck.de

    Recruiting

  • St. Annastift Krankenhaus

    Ludwigshafen, 67065

    Barbara Selle, MD, 49-621-57021

    Recruiting

  • Universitatsklinikum der MA

    Magdeburg, 39120

    Uwe Mittler, MD, 49-391-671-7210

    Recruiting

  • Johannes Gutenberg University

    Mainz, D-55101

    P. Gutjahr, MD, 49-6131-172-112

    Recruiting

  • Staedtisches Klinik - Kinderklinik

    Mannheim, D-68167

    M. Duerken, 49-621-383-2244

    Recruiting

  • Universitaets - Kinderklinik

    Marburg, 35033

    H. Christiansen, MD, 49-6421-286-2650

    Recruiting

  • Klinikum Minden

    Minden, D-32423

    W Tilmann, MD, 49-571-801-4601

    Recruiting

  • Krankenhaus Muenchen Schwabing

    Munich, 80804

    Stefan Burdach, MD, PhD, 49-89-3068-2276

    Recruiting

  • Dr. von Haunersches Kinderspital der Universitaet Muenchen

    Munich, D-80337

    Arndt Borkhardt, 49-89-5160-2842

    Recruiting

  • Klinikum der Universitaet Muenchen - Grosshadern Campus

    Munich, D-81377

    Schulz, MD, 49-89-7095-2404

    Recruiting

  • Staedtisches Krankenhaus Muenchen - Harlaching

    Munich, D-81545

    Contact Person, 49-89-6210-2443

    Recruiting

  • University of Muenster

    Münster, D-48129

    Contact Person, 44-251-834-7742

    Recruiting

  • Klinikum Neubrandenburg

    Neubrandenburg, 17036

    H. J. Feickert, MD, PhD, 49-395-775-2901, feickerthj@dbk-nb.de

    Recruiting

  • Kinderklinik Kohlhof

    Neunkirchen, D-66539

    Contact Person, 49-681-3630

    Recruiting

  • Cnopf'sche Kinderklinik

    Nuremberg, 90419

    W. Scheurlen, 49-911-334-002

    Recruiting

  • Klinikum Oldenburg

    Oldenburg, 26133

    Hermann Mueller, MD, 49-441-403-2013, mueller.hermann@klinikum-oldenburg.de

    Recruiting

  • Klinik St. Hedwig-Kinderklinik

    Regensburg, 93049

    Ove Peters, 49-941-3690

    Recruiting

  • Kinderklinik - Universitaetsklinikum Rostock

    Rostock, D-18057

    Carl Friedrich Classen, MD, PD, 49-381-4940, carl-friedrich.classen@med.uni-rostock.de

    Recruiting

  • Johanniter-Kinderklinik

    Sankt Augustin, 53757

    Roswitha Dickerhoff, MD, 49-2241-2490, roswitha.dickerhoft@uni-bonn.de

    Recruiting

  • Kinderklink Siegen Deutsches Rotes Kreuz

    Siegen, D-57072

    Rainer Burghard, MD, 49-271-23450, rainer.burghard@drk-kinderklinik.de

    Recruiting

  • Olgahospital

    Stuttgart, D-70176

    Stefan Bielack, MD, 49-711-992-460, st.bielack@olgahospital.de

    Recruiting

  • Krankenanstalt Mutterhaus der Borromaerinnen

    Trier, D-54290

    Wolfgang Rauh, MD, 49-651-947-2620

    Recruiting

  • Universitaets-Kinderklinik

    Tübingen, D-72070

    Contact Person, 49-707-1298-3781

    Recruiting

  • Universitaetsklinikum Tuebingen

    Tübingen, D-72076

    Rupert Handgretinger, MD, 49-7071-298-3781

    Recruiting

  • Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm

    Ulm, D-89075

    Klaus M. Debatin, MD, 49-731-5002-7790, klaus-michael.debatin@medizin.uni-ulm.de

    Recruiting

  • Reinhard-Nieter-Krankenhaus

    Wilhelmshaven, D-26389

    Liebner, MD, 49-4421-891-840

    Recruiting

  • Helios Kliniken Wuppertal University Hospital

    Wuppertal, D-42283

    K. Sinha, MD, 49-202-896-2441

    Recruiting

  • Universitaets - Kinderklinik Wuerzburg

    Würzburg, D-97080

    P. G. Schlegel, MD, 49-931-2010, schlegel@mail.uni-wuerzburg.de

    Recruiting

Other trials in Germany

Switzerland5 sites, 5 recruiting

  • Kantonsspital Aarau

    Aarau, CH-5001

    R. Angst, 49-41-628-384-941

    Recruiting

  • Universitaets-Kinderspital beider Basel

    Basel, CH-4005

    Thomas Kuhne, MD, 49-41-616-856-565, thomas.kuehne@ukbb.ch

    Recruiting

  • Kinderspital Luzern

    Lucerne, CH-6000

    U. Caflisch, MD, 49-41-412-051-111

    Recruiting

  • Ostschweizer Kinderspital

    Sankt Gallen, CH-9006

    Jeanette Greiner, MD, 49-41-712-437-111, jeanette.greiner@kispisg.ch

    Recruiting

  • University Children's Hospital

    Zurich, CH-8032

    Felix Niggli, MD, 49-41-1266-7111

    Recruiting

Other trials in Switzerland

About this study

Official title: NB2004 Trial Protocol for Risk Adapted Treatment of Children With Neuroblastoma

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. An autologous stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy and radiation therapy. This may allow more chemotherapy to be given so that more tumor cells are killed. Sometimes, after surgery, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether observation is more effective than combination chemotherapy, radiation therapy, and/or autologous stem cell transplant in treating neuroblastoma.

PURPOSE: This randomized phase III and phase IV trial is studying observation, combination chemotherapy, radiation therapy, and/or autologous stem cell transplant to compare how well they work in treating young patients with neuroblastoma.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the event-free survival (EFS) of younger patients with newly diagnosed neuroblastoma categorized in the low-risk group (LRG) who undergo observation only or receive combination chemotherapy.
  • Compare the EFS rate in patients with neuroblastoma categorized in the medium-risk group (MRG) treated with combination induction therapy, maintenance therapy, and consolidation therapy with that of a historical control group.
  • Compare the EFS in patients with neuroblastoma categorized in the high-risk group (HRG) treated with standard vs experimental induction therapy followed by autologous stem cell transplantation and consolidation therapy.

Secondary

  • Determine the locoregional EFS of patients in the LRG, MRG, or HRG.
  • Determine the overall survival of these patients.
  • Determine the extent of initial surgery, the extent or impact of best surgery, and surgery-related complications in these patients.
  • Determine the time to transition to stage 4 disease in patients in the LRG or MRG.
  • Determine the time to a locoregional event in patients in the LRG or HRG.
  • Determine the time from diagnosis to an event in patients in the LRG.
  • Determine the time from the beginning of regression to an adverse event in patients in the LRG.
  • Determine the time to the beginning of primary tumor regression in patients in the LRG.
  • Determine the time to the normalization of tumor markers in patients in the LRG.
  • Determine the time to no evidence of disease in patients in the LRG with stage 4S disease.
  • Assess the status of the primary tumor at 12 months and the best status of the primary tumor within 12 months in patients in the LRG.
  • Determine the need for chemotherapy to control progression and the intensity of therapy required in patients in the LRG.
  • Determine the acute and late side effects of external-beam radiotherapy in patients in the MRG or HRG.
  • Determine the response to induction therapy in patients in the HRG.
  • Assess early response after 2 courses of induction therapy in patients in the HRG.
  • Determine the toxicity during induction courses 1 and 2 and the frequency of grade 3 or 4 toxicity during induction therapy in patients in the HRG.
  • Assess the efficacy of iodine I 131 metaiodobenzylguanidine (MIBG) therapy, in terms of activity and whole body dose, in patients in the HRG.
  • Assess molecular markers (e.g., chromosome 1p, chromosome 11q, neuroblastoma gene chip) in these patients.

OUTLINE: This is a prospective, historically controlled, randomized, open-label, multicenter study. Patients are stratified according to disease risk (low-risk vs medium-risk vs high-risk).

  • Low-risk group: Patients undergo complete staging 3 months after initial surgery. Patients with no progression are observed for 12 months (for patients over 1 year of age) or until the end of the second year of life (for patients 1 year of age or younger). Patients with localized progression or threatening symptoms undergo N4 chemotherapy comprising doxorubicin hydrochloride IV over 30 minutes and vincristine IV on days 1, 3, and 5 and cyclophosphamide IV over 30 minutes on days 1-7. Treatment repeats every 21 days for up to 4 courses. Patients are reassessed after each course of N4 chemotherapy. Patients achieving stable disease or tumor regression at any point discontinue N4 chemotherapy and undergo observation. Patients with persistent progressive disease after 4 courses of N4 chemotherapy proceed to treatment as in the medium-risk group. Patients who progress to stage 4 disease after initial surgery proceed to treatment as in the medium-risk group (for patients 1 year of age or younger and no indication of stage 4S disease) or high-risk group (for patients over 1 year of age).
  • Medium-risk group: Patients receive induction therapy followed by maintenance therapy and consolidation therapy.
  • Induction therapy: Patients* receive N5 chemotherapy comprising cisplatin IV continuously over 96 hours and etoposide phosphate IV continuously over 96 hours on days 1-4, vindesine IV over 1 hour on day 1, and filgrastim (G-CSF) subcutaneously (SC) beginning on day 9 and continuing until blood counts recover. Patients then receive N6 chemotherapy comprising vincristine IV over 1 hour on days 1 and 8, dacarbazine IV over 1 hour and ifosfamide IV continuously over 120 hours on days 1-5, doxorubicin hydrochloride IV over 4 hours on days 6 and 7, and G-CSF beginning on day 10 and continuing until blood counts recover. Treatment repeats every 21 days alternating between N5 and N6 chemotherapy for up to 6 total courses (3 courses of N5 and N6 each). Patients then proceed to maintenance therapy.

NOTE: *Patients under 6 months of age receive up to 4 courses of N4 chemotherapy (as in the low-risk group) instead of N5/N6 chemotherapy until they reach 6 months of age.

Patients with active residual tumor after induction chemotherapy undergo external-beam radiotherapy (EBRT) for up to 25 fractions concurrently with maintenance chemotherapy. Secondary surgery for resection of the primary tumor is attempted after course 4 or 6 of the induction therapy and before EBRT.

  • Maintenance therapy: Patients receive N7 chemotherapy comprising cyclophosphamide orally or IV over 1 hour on days 1-8. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
  • Consolidation therapy: Beginning 21 days after completion of maintenance therapy, patients receive oral isotretinoin 2-3 times daily on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of unacceptable toxicity. Patients then receive 3 additional courses after 3-months of rest.
  • High-risk group: Patients receive induction therapy followed by autologous stem cell transplantation (ASCT) and consolidation therapy.
  • Induction therapy: Patients 1 year of age and over are randomized to 1 of 2 treatment arms. Patients under 1 year of age do not undergo randomization; instead they are assigned to arm I.
  • Arm I (standard): Patients* receive N5 and N6 chemotherapy as in induction therapy for the medium-risk group.
  • Arm II (experimental): Patients receive N8 chemotherapy comprising topotecan hydrochloride IV continuously over 168 hours and cyclophosphamide IV over 1 hour on days 1-7, etoposide IV over 1 hour on days 8-10, and G-CSF SC beginning on day 12 and continuing until blood counts recover. Treatment repeats every 21 days for 2 courses. Patients then receive N5 and N6 chemotherapy as in induction therapy for the medium-risk group.

In both arms, patients with active residual primary tumor after 6 courses of induction therapy undergo iodine I 131 metaiodobenzylguanidine (MIBG)** radiotherapy (before ASCT). Patients also undergo EBRT for up to 25 fractions after ASCT. Secondary surgery for resection of the primary tumor is attempted after course 4 or 6 of induction therapy and before radiotherapy.

NOTE: *Patients under 6 months of age receive up to 4 courses of N4 chemotherapy (as in the low-risk group) instead of N5/N6 chemotherapy until they reach 6 months of age.

NOTE: **Patients with MIBG-negative disease undergo EBRT only.

  • Conditioning followed by ASCT: Patients receive melphalan IV over 30 minutes on days -8 to -5, etoposide phosphate IV over 4 hours on day -4, and carboplatin IV over 1 hour on days -4 to -2. Patients undergo ASCT on day 0. Patients receive G-CSF SC beginning on day 2 and continuing until blood counts recover.
  • Consolidation therapy: Beginning 30 days after ASCT, patients receive isotretinoin* as in consolidation therapy for the medium-risk group.

NOTE: *Isotretinoin is discontinued during EBRT and restarted 1 week after completion of EBRT.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 642 patients will be accrued for this study.

Conditions
Neuroblastoma
Being tested
filgrastim, carboplatin, cisplatin, cyclophosphamide, dacarbazine
Keywords
localized resectable neuroblastoma, localized unresectable neuroblastoma, regional neuroblastoma, stage 4S neuroblastoma, disseminated neuroblastoma, recurrent neuroblastoma
Medical subject headings
Neuroblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Event-free survival (EFS)

  2. Locoregional EFS

Secondary outcomes (21)

  1. 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)

  2. Overall survival

  3. Time to the beginning of primary tumor regression (in patients in the low-risk group [LRG])

  4. Time to the normalization of tumor markers HVA and VMA in urine

  5. Time to no evidence of disease (in patients in the LRG with stage 4S disease)

  6. Status of the primary tumor 12 months after diagnosis (LRG)

  7. Best status of the primary tumor within the first 12 months (LRG)

  8. Status of chromosome 1p (unblinded) and status of chromosome 11q (blinded)

  9. Comparison of the extent of initial surgery (incomplete resection vs macroscopic complete resection) (LRG)

  10. Comparison of the extent of best surgery during protocol treatment (incomplete resection vs macroscopic complete resection)

  11. Surgery-related complications (i.e., bleeding, infection, intestinal obstruction, or other)

  12. Disease progression and symptoms controlled after the first, second, third, and fourth N4 course (LRG)

  13. Disease progression and symptoms not controlled after four N4 courses (LRG)

  14. Transition to stage 4 disease at any time (LRG)

  15. Acute and late side effects of external-beam radiotherapy (medium-risk group [MRG] and high-risk group [HRG])

  16. Early response after 2 courses of induction therapy (N5 and N6 or two courses of N8) (HRG)

  17. Response to induction therapy prior to conditioning therapy or after 280 days (HRG)

  18. Grade of toxicity observed during induction therapy course 1 (N5 or N8) (HRG)

  19. Grade of toxicity observed during induction therapy course 2 (N6 or N8) (HRG)

  20. Frequency of grade 3 or 4 toxicity observed during the last 6 courses of induction therapy (3 courses of N5 and N6) (HRG)

  21. Activity and whole body dose of radiotherapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2006 (estimated)
  2. Study startOct 2004
  3. Primary completionDec 2010 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Masking
None (open label)
Enrolment
642 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00410631
Sponsor's protocol ID
GPOH-NB2004
Other IDs
CDR0000517312, EU-20661
Status last verified
Jan 2008
First submitted
11 Dec 2006
Last updated
7 Aug 2013
Results posted
No

Publications

  • Decarolis B, Simon T, Krug B, Leuschner I, Vokuhl C, Kaatsch P, von Schweinitz D, Klingebiel T, Mueller I, Schweigerer L, Berthold F, Hero B. Treatment and outcome of Ganglioneuroma and Ganglioneuroblastoma intermixed. BMC Cancer. 2016 Jul 27;16:542. doi: 10.1186/s12885-016-2513-9.

    PubMed 27465021

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing filgrastim, carboplatin and cisplatin in people with Neuroblastoma, run by German Society for Pediatric Oncology and Hematology GPOH gGmbH at 80 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 80 sites in Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Event-free survival (EFS). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00410631, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2013.

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