Clinical trial NCT00003804: Chemotherapy Plus Surgery in Treating Children at Risk of or With Stage I Wilms' Tumor
Official title: Nephroblastoma Clinical Trial and Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Kidney Cancer
Keywords: stage I Wilms tumor
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2004-07-16
Enrollment: 350
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.

Detailed description: 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.

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. Peer Reviewed and Funded or Endorsed by Cancer Research UK

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

Eligibility 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

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Montegnee
country: Belgium
facility: Clinique de l'Esperance
city: Split
country: Croatia
facility: Clinical Hospital Center Split
city: Brno
country: Czech Republic
facility: University Children Hospital
city: Aalborg
country: Denmark
facility: Aalborg Hospital
city: Aarhus
country: Denmark
facility: Universtiy Hospital of Aarhus
city: Odense
country: Denmark
facility: Odense University Hospital
city: Amiens
country: France
facility: Hopital Nord Amiens
city: Besancon
country: France
facility: CHR de Besancon - Hopital Saint-Jacques
city: Bordeaux
country: France
facility: CHU de Bordeaux - Hopital Pellegrin
city: Brest
country: France
facility: C.H.U. de Brest
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lille
country: France
facility: Centre Hospitalier Regional de Lille
city: Limoges
country: France
facility: Centre Hospital Regional Universitaire de Limoges
city: Lyon
country: France
facility: Centre Leon Berard
city: Marseille
country: France
facility: Hopital d'Enfants de la Timone
city: Montpellier
country: France
facility: Hopital Arnaud de Villeneuve
city: Nantes
country: France
facility: CHR Hotel Dieu
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Saint Etienne
country: France
facility: C.H.U. Saint Etienne Hospital Nord
city: Strasbourg
country: France
facility: Hopitaux Universitaire de Strasbourg
city: Toulouse
country: France
facility: Centre Hospitalier Regional de Purpan
city: Tours
country: France
facility: C.H. Bastien de Clocheville
city: Vandoeuvre-Les-Nancy
country: France
facility: CHRU de Nancy - Hopitaux de Brabois
city: Athens
country: Greece
facility: Children's Hospital A. Kyriakou
city: San Sisto Perugia
country: Italy
facility: Ospedale Raffaele Silvestrini
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum
city: Amsterdam
country: Netherlands
facility: Academisch Ziekenhuis der Vrije Universiteit
city: Amsterdam
country: Netherlands
facility: Emma Kinderziekenhuis
city: Nijmegen
country: Netherlands
facility: University Medical Center Nijmegen
city: Bergen
country: Norway
facility: Haukeland Hospital - University of Bergen
city: Tromso
country: Norway
facility: University of Tromso
city: Trondheim
country: Norway
facility: Regionsykehuset & University Hospital
city: Wroclaw (Breslau)
country: Poland
facility: Wroclaw Medical University
city: Porto
country: Portugal
facility: Hospital Escolar San Joao
city: Ljubljana
country: Slovenia
facility: Pediatricna Klinika
city: Barcelona
country: Spain
facility: Hospital General Universitari Vall d'Hebron
city: Madrid
country: Spain
facility: Centro Medico "La Zarzuela"
city: Madrid
country: Spain
facility: Hospital Universitario LaPaz
city: Malaga
country: Spain
facility: Hospital Materno-Infantil
city: Santiago de Compostela
country: Spain
facility: Hospital General de Galicia
city: Vizcaya
country: Spain
facility: Hospital Des Cruces
city: Lund
country: Sweden
facility: Lund University Hospital
city: Stockholm
country: Sweden
facility: Karolinska Hospital
city: Abu Dhabi
country: United Arab Emirates
facility: Tawam Hospital
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Jan DeKraker, MD
role: STUDY_CHAIR
References:
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