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.

Condition	Treatment or Intervention	Phase
stage I Wilms' tumor	Drug: dactinomycin  Drug: vincristine	Phase III

Further Study Details: 

OBJECTIVES: I. Determine the initial extension of disease, surgical procedures, gross and histological morphology, treatments, clinical outcome, and late consequences of therapy after treatment with neoadjuvant chemotherapy, surgery, and adjuvant chemotherapy with or without maintenance chemotherapy in patients with intermediate risk or anaplastic stage I Wilms' tumor.

II. Determine the safety and effectiveness of reduced chemotherapy in these patients.

PROTOCOL OUTLINE: This is a randomized, multicenter study.

Patients receive dactinomycin IV on days 1-3 and 15-17 and vincristine IV on days 1, 8, 15, and 22. Patients then undergo surgery about a week after completion of chemotherapy. After surgery, patients receive vincristine IV on days 1, 8, 15, and 22 and dactinomycin IV on days 8-12. Patients are then randomized to one of two treatment arms after week 9.

Arm I: Patients receive dactinomycin IV on days 1-5 of week 10 and vincristine IV on day 1 of both weeks 10 and 11. This course is repeated during weeks 17 and 18.

Arm II: Patients receive no further treatment.

Patients are followed every 3 months for 3 years, then annually thereafter.

PROJECTED ACCRUAL: A total of 350 patients (175 per treatment arm) will be accrued for this study within 7-8 years.

Ages Eligible for Study:  up to  17 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--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

--Prior/Concurrent Therapy--

• See Disease Characteristics

--Patient Characteristics--

• Age: 0.5 to 17
• Performance status: Not specified
• Life expectancy: Not specified
• Hematopoietic: Not specified
• Hepatic: Not specified
• Renal: Not specified

Belgium
      Clinique de l'Esperance, Montegnee,  4420,  Belgium
Croatia
      Clinical Hospital Center Split, Split,  21000,  Croatia
Czech Republic
      University Children Hospital, Brno,  662 63,  Czech Republic
Denmark
      Aalborg Hospital, Aalborg,  DK-9000,  Denmark
      Odense University Hospital, Odense,  DK-5000,  Denmark
      Universtiy Hospital of Aarhus, Aarhus,  8200,  Denmark
France
      C.H. Bastien de Clocheville, Tours,  3700,  France
      C.H.U. de Brest, Brest,  29200,  France
      C.H.U. Saint Etienne Hospital Nord, Saint-Etienne,  42055,  France
      Centre Antoine Lacassagne, Nice,  06189,  France
      Centre Hospital Regional Universitaire de Limoges, Limoges,  87042,  France
      Centre Hospitalier Regional de Lille, Lille,  59037,  France
      Centre Hospitalier Regional de Purpan, Toulouse,  31059,  France
      Centre Leon Berard, Lyon,  69373,  France
      Centre Oscar Lambret, Lille,  59020,  France
      CHR de Besancon - Hopital Saint-Jacques, Besancon,  25030,  France
      CHR Hotel Dieu, Nantes,  44093,  France
      CHRU de Nancy - Hopitaux de Brabois, Vandoeuvre-les-Nancy,  54511,  France
      CHU de Bordeaux - Hopital Pellegrin, Bordeaux,  33076,  France
      Hopital Arnaud de Villeneuve, Montpellier,  34295,  France
      Hopital d'Enfants de la Timone, Marseille,  13385,  France
      Hopital Nord Amiens, Amiens,  80054,  France
      Hopitaux Universitaire de Strasbourg, Strasbourg,  67091,  France
Greece
      Children's Hospital A. Kyriakou, Athens,  617,  Greece
Italy
      Ospedale Raffaele Silvestrini, San Sisto Perugia,  06100,  Italy
Netherlands
      Academisch Medisch Centrum, Amsterdam,  1105 AZ,  Netherlands
      Academisch Ziekenhuis der Vrije Universiteit, Amsterdam,  1117 MB,  Netherlands
      Emma Kinderziekenhuis, Amsterdam,  NL-1100 DE,  Netherlands
      University Medical Center Nijmegen, Nijmegen,  NL-6252 HB,  Netherlands
Norway
      Haukeland Hospital - University of Bergen, BERGEN,  N-5021,  Norway
      Regionsykehuset & University Hospital, Trondheim,  7006,  Norway
      University of Tromso, Tromso,  N-9037,  Norway
Poland
      Wroclaw Medical University, Wroclaw (Breslau),  50-367,  Poland
Portugal
      Hospital Escolar San Joao, Porto,  4200,  Portugal
Slovenia
      Pediatricna Klinika, LJUBLJANA,  61000,  Slovenia
Spain
      Centro Medico "La Zarzuela", Madrid,  28023,  Spain
      Hospital Des Cruces, Vizcaya,  48,  Spain
      Hospital General de Galicia, Santiago de Compostela,  15705,  Spain
      Hospital General Universitari Vall d'Hebron, Barcelona,  08035,  Spain
      Hospital Materno-Infantil, Malaga,  29011,  Spain
      Hospital Universitario LaPaz, Madrid,  28046,  Spain
Sweden
      Karolinska Hospital, Stockholm,  S-171 76,  Sweden
      Lund University Hospital, Lund,  SE-22-1 85,  Sweden
United Arab Emirates
      Tawam Hospital, Abu Dhabi,  United Arab Emirates

Study chairs or principal investigators

Jan DeKraker,  Study Chair,  Societe Internationale d'Oncologie Pediatrique   

Study ID Numbers:  CDR0000066948; SIOP-93-01; EU-98064
Record last reviewed:  July 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003804
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08