Spots Global Cancer Trial Database for Chemotherapy Plus Surgery in Treating Children at Risk of or With Stage I Wilms' Tumor
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Chemotherapy Plus Surgery in Treating Children at Risk of or With Stage I Wilms' Tumor
Official Title: Nephroblastoma Clinical Trial and Study
Study ID: NCT00003804
Conditions
Study Description
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.
Keywords
Eligibility
Minimum Age:
Eligible Ages: CHILD
Sex: ALL
Healthy Volunteers: No
Locations
Clinique de l'Esperance, Montegnee, , Belgium
Clinical Hospital Center Split, Split, , Croatia
University Children Hospital, Brno, , Czech Republic
Aalborg Hospital, Aalborg, , Denmark
Universtiy Hospital of Aarhus, Aarhus, , Denmark
Odense University Hospital, Odense, , Denmark
Hopital Nord Amiens, Amiens, , France
CHR de Besancon - Hopital Saint-Jacques, Besancon, , France
CHU de Bordeaux - Hopital Pellegrin, Bordeaux, , France
C.H.U. de Brest, Brest, , France
Centre Oscar Lambret, Lille, , France
Centre Hospitalier Regional de Lille, Lille, , France
Centre Hospital Regional Universitaire de Limoges, Limoges, , France
Centre Leon Berard, Lyon, , France
Hopital d'Enfants de la Timone, Marseille, , France
Hopital Arnaud de Villeneuve, Montpellier, , France
CHR Hotel Dieu, Nantes, , France
Centre Antoine Lacassagne, Nice, , France
C.H.U. Saint Etienne Hospital Nord, Saint Etienne, , France
Hopitaux Universitaire de Strasbourg, Strasbourg, , France
Centre Hospitalier Regional de Purpan, Toulouse, , France
C.H. Bastien de Clocheville, Tours, , France
CHRU de Nancy - Hopitaux de Brabois, Vandoeuvre-Les-Nancy, , France
Children's Hospital A. Kyriakou, Athens, , Greece
Ospedale Raffaele Silvestrini, San Sisto Perugia, , Italy
Academisch Medisch Centrum, Amsterdam, , Netherlands
Academisch Ziekenhuis der Vrije Universiteit, Amsterdam, , Netherlands
Emma Kinderziekenhuis, Amsterdam, , Netherlands
University Medical Center Nijmegen, Nijmegen, , Netherlands
Haukeland Hospital - University of Bergen, Bergen, , Norway
University of Tromso, Tromso, , Norway
Regionsykehuset & University Hospital, Trondheim, , Norway
Wroclaw Medical University, Wroclaw (Breslau), , Poland
Hospital Escolar San Joao, Porto, , Portugal
Pediatricna Klinika, Ljubljana, , Slovenia
Hospital General Universitari Vall d'Hebron, Barcelona, , Spain
Centro Medico "La Zarzuela", Madrid, , Spain
Hospital Universitario LaPaz, Madrid, , Spain
Hospital Materno-Infantil, Malaga, , Spain
Hospital General de Galicia, Santiago de Compostela, , Spain
Hospital Des Cruces, Vizcaya, , Spain
Lund University Hospital, Lund, , Sweden
Karolinska Hospital, Stockholm, , Sweden
Tawam Hospital, Abu Dhabi, , United Arab Emirates
Contact Details
Name: Jan DeKraker, MD
Affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Role: STUDY_CHAIR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
