Chemotherapy Plus Surgery in Treating Children at Risk of or With Stage I Wilms' Tumor

NCT00003804 | Unknown Phase 3

• 3 other identifiers: CDR0000066948SIOP-93-01EU-98064
• Study Type: interventional
• Target: 350
• Locations: 15 countries
• Sites: 44

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known which regimen of chemotherapy is more effective for stage I Wilms' tumor. PURPOSE: Randomized phase III trial to study the effectiveness of chemotherapy and surgery in treating children who are at risk of or who have stage I Wilms' tumor.

Conditions

Kidney Cancer

Keywords

stage I Wilms tumor

Interventions

dactinomycin BIOLOGICAL

vincristine sulfate DRUG

conventional surgery PROCEDURE

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

DISEASE CHARACTERISTICS: Initial diagnosis of a unilateral tumor with clinical and radiological characteristics of a nephroblastoma Histologically proven stage I Wilms' tumor after neoadjuvant treatment and surgery Intermediate risk or anaplastic No detectable distant metastases 4 weeks after adjuvant chemotherapy PATIENT CHARACTERISTICS: Age: 0.5 to 17 Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified PRIOR CONCURRENT THERAPY: See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Leicester: lead

Study Sites (44)

Clinique de l'Esperance

Montegnée, 4420, Belgium

Location

Clinical Hospital Center Split

Split, 21000, Croatia

Location

University Children Hospital

Brno, 662 63, Czechia

Location

Aalborg Hospital

Aalborg, DK-9000, Denmark

Location

Universtiy Hospital of Aarhus

Aarhus, 8200, Denmark

Location

Odense University Hospital

Odense, DK-5000, Denmark

Location

Hopital Nord Amiens

Amiens, 80054, France

Location

CHR de Besancon - Hopital Saint-Jacques

Besançon, 25030, France

Location

CHU de Bordeaux - Hopital Pellegrin

Bordeaux, 33076, France

Location

C.H.U. de Brest

Brest, 29200, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Centre Hospitalier Regional de Lille

Lille, 59037, France

Location

Centre Hospital Regional Universitaire de Limoges

Limoges, 87042, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

Hopital d'Enfants de la Timone

Marseille, 13385, France

Location

Hopital Arnaud de Villeneuve

Montpellier, 34295, France

Location

CHR Hotel Dieu

Nantes, 44093, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

C.H.U. Saint Etienne Hospital Nord

Saint-Etienne, 42055, France

Location

Hopitaux Universitaire de Strasbourg

Strasbourg, 67091, France

Location

Centre Hospitalier Regional de Purpan

Toulouse, 31059, France

Location

C.H. Bastien de Clocheville

Tours, 3700, France

Location

CHRU de Nancy - Hopitaux de Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

Children's Hospital A. Kyriakou

Athens, 617, Greece

Location

Ospedale Raffaele Silvestrini

San Sisto Perugia, 06100, Italy

Location

Academisch Medisch Centrum

Amsterdam, 1105 AZ, Netherlands

Location

Academisch Ziekenhuis der Vrije Universiteit

Amsterdam, 1117 MB, Netherlands

Location

Emma Kinderziekenhuis

Amsterdam, NL-1100 DE, Netherlands

Location

University Medical Center Nijmegen

Nijmegen, NL-6252 HB, Netherlands

Location

Haukeland Hospital - University of Bergen

Bergen, N-5021, Norway

Location

University of Tromso

Tromsø, N-9037, Norway

Location

Regionsykehuset & University Hospital

Trondheim, 7006, Norway

Location

Wroclaw Medical University

Wroclaw (Breslau), 50-367, Poland

Location

Hospital Escolar San Joao

Porto, 4200, Portugal

Location

Pediatricna Klinika

Ljubljana, 61000, Slovenia

Location

Hospital General Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Centro Medico "La Zarzuela"

Madrid, 28023, Spain

Location

Hospital Universitario LaPaz

Madrid, 28046, Spain

Location

Hospital Materno-Infantil

Málaga, 29011, Spain

Location

Hospital General de Galicia

Santiago de Compostela, 15705, Spain

Location

Hospital Des Cruces

Vizcaya, 48, Spain

Location

Lund University Hospital

Lund, SE-22-1 85, Sweden

Location

Karolinska Hospital

Stockholm, S-171 76, Sweden

Location

Tawam Hospital

Abu Dhabi, United Arab Emirates

Location

Related Publications (16)

• Sudour H, Audry G, Schleimacher G, Patte C, Dussart S, Bergeron C. Bilateral Wilms tumors (WT) treated with the SIOP 93 protocol in France: epidemiological survey and patient outcome. Pediatr Blood Cancer. 2012 Jul 15;59(1):57-61. doi: 10.1002/pbc.24059. Epub 2012 Jan 11.

  PMID: 22238153 BACKGROUND

• Warmann SW, Nourkami N, Fruhwald M, Leuschner I, Schenk JP, Fuchs J, Graf N. Primary lung metastases in pediatric malignant non-Wilms renal tumors: data from SIOP 93-01/GPOH and SIOP 2001/GPOH. Klin Padiatr. 2012 Apr;224(3):148-52. doi: 10.1055/s-0032-1304600. Epub 2012 Apr 18.

  PMID: 22513793 BACKGROUND

• Furtwangler R, Nourkami N, Alkassar M, von Schweinitz D, Schenk JP, Rube C, Siemer S, Leuschner I, Graf N. Update on relapses in unilateral nephroblastoma registered in 3 consecutive SIOP/GPOH studies - a report from the GPOH-nephroblastoma study group. Klin Padiatr. 2011 May;223(3):113-9. doi: 10.1055/s-0031-1275293. Epub 2011 Apr 20.

  PMID: 21509706 BACKGROUND

• van den Heuvel-Eibrink MM, van Tinteren H, Rehorst H, Coulombe A, Patte C, de Camargo B, de Kraker J, Leuschner I, Lugtenberg R, Pritchard-Jones K, Sandstedt B, Spreafico F, Graf N, Vujanic GM. Malignant rhabdoid tumours of the kidney (MRTKs), registered on recent SIOP protocols from 1993 to 2005: a report of the SIOP renal tumour study group. Pediatr Blood Cancer. 2011 May;56(5):733-7. doi: 10.1002/pbc.22922. Epub 2010 Dec 22.

  PMID: 21370404 BACKGROUND

• Warmann SW, Furtwangler R, Blumenstock G, Armeanu S, Nourkami N, Leuschner I, Schenk JP, Graf N, Fuchs J. Tumor biology influences the prognosis of nephroblastoma patients with primary pulmonary metastases: results from SIOP 93-01/GPOH and SIOP 2001/GPOH. Ann Surg. 2011 Jul;254(1):155-62. doi: 10.1097/SLA.0b013e318222015e.

  PMID: 21670612 BACKGROUND

• van den Heuvel-Eibrink MM, Grundy P, Graf N, Pritchard-Jones K, Bergeron C, Patte C, van Tinteren H, Rey A, Langford C, Anderson JR, de Kraker J. Characteristics and survival of 750 children diagnosed with a renal tumor in the first seven months of life: A collaborative study by the SIOP/GPOH/SFOP, NWTSG, and UKCCSG Wilms tumor study groups. Pediatr Blood Cancer. 2008 Jun;50(6):1130-4. doi: 10.1002/pbc.21389.

  PMID: 18095319 BACKGROUND

• Luithle T, Szavay P, Furtwangler R, Graf N, Fuchs J; SIOP/GPOH Study Group. Treatment of cystic nephroma and cystic partially differentiated nephroblastoma--a report from the SIOP/GPOH study group. J Urol. 2007 Jan;177(1):294-6. doi: 10.1016/j.juro.2006.09.011.

  PMID: 17162067 BACKGROUND

• Szavay P, Luithle T, Graf N, Furtwangler R, Fuchs J. Primary hepatic metastases in nephroblastoma--a report of the SIOP/GPOH Study. J Pediatr Surg. 2006 Jan;41(1):168-72; discussion 168-72. doi: 10.1016/j.jpedsurg.2005.10.021.

  PMID: 16410128 BACKGROUND

• Boccon-Gibod LA. Pathological evaluation of renal tumors in children: international society of pediatric oncology approach. Pediatr Dev Pathol. 1998 May-Jun;1(3):243-8. doi: 10.1007/s100249900033.

  PMID: 10463285 RESULT

• Fuchs J, Kienecker K, Furtwangler R, Warmann SW, Burger D, Thurhoff JW, Hager J, Graf N. Surgical aspects in the treatment of patients with unilateral wilms tumor: a report from the SIOP 93-01/German Society of Pediatric Oncology and Hematology. Ann Surg. 2009 Apr;249(4):666-71. doi: 10.1097/SLA.0b013e31819ed92b.

  PMID: 19300220 RESULT

• Furtwangler R, Reinhard H, Beier R, et al.: Clear-cell sarcoma (CCSK) of the kidney - results of the SIOP 93-01/GPOH trial. [Abstract] Pediatr Blood Cancer 45 (4 Suppl 1): A-0.155, 423, 2005.

  RESULT

• Ora I, van Tinteren H, Bergeron C, de Kraker J; SIOP Nephroblastoma Study Committee. Progression of localised Wilms' tumour during preoperative chemotherapy is an independent prognostic factor: a report from the SIOP 93-01 nephroblastoma trial and study. Eur J Cancer. 2007 Jan;43(1):131-6. doi: 10.1016/j.ejca.2006.08.033. Epub 2006 Nov 2.

  PMID: 17084075 RESULT

• Reinhard H, Aliani S, Ruebe C, Stockle M, Leuschner I, Graf N. Wilms' tumor in adults: results of the Society of Pediatric Oncology (SIOP) 93-01/Society for Pediatric Oncology and Hematology (GPOH) Study. J Clin Oncol. 2004 Nov 15;22(22):4500-6. doi: 10.1200/JCO.2004.12.099.

  PMID: 15542800 RESULT

• Reinhard H, Semler O, Burger D, Bode U, Flentje M, Gobel U, Gutjahr P, Leuschner I, Maass E, Niggli F, Scheel-Walter HG, Stockle M, Thuroff JW, Troger J, Weirich A, von Schweinitz D, Zoubek A, Graf N. Results of the SIOP 93-01/GPOH trial and study for the treatment of patients with unilateral nonmetastatic Wilms Tumor. Klin Padiatr. 2004 May-Jun;216(3):132-40. doi: 10.1055/s-2004-822625.

  PMID: 15175957 RESULT

• Verschuur AC, Vujanic GM, Van Tinteren H, Jones KP, de Kraker J, Sandstedt B. Stromal and epithelial predominant Wilms tumours have an excellent outcome: the SIOP 93 01 experience. Pediatr Blood Cancer. 2010 Aug;55(2):233-8. doi: 10.1002/pbc.22496.

  PMID: 20582946 RESULT

• Vujanic GM, Harms D, Bohoslavsky R, Leuschner I, de Kraker J, Sandstedt B. Nonviable tumor tissue should not upstage Wilms' tumor from stage I to stage II: a report from the SIOP 93-01 nephroblastoma trial and study. Pediatr Dev Pathol. 2009 Mar-Apr;12(2):111-5. doi: 10.2350/08-03-0432.1. Epub 2008 Sep 23.

  PMID: 18811224 RESULT

MeSH Terms

Conditions

Kidney Neoplasms; Wilms Tumor

Interventions

Dactinomycin; Vincristine

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Indolizidines; Indolizines

Study Officials

• Jan DeKraker, MD

  Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: July 16, 2004
• Study Start: July 1, 1993
• Last Updated: June 24, 2014

Record last verified: 2012-04

Locations

PT (1); NO (3); SL (1); NL (4); GR (1); PL (1); SE (2); DK (3); CR (1); FR (17); ES (6); BE (1); CZ (1); AE (1); IT (1)