Chemotherapy Plus Surgery in Treating Children at Risk of or With Stage I Wilms' Tumor
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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.
Study Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinique de l'Esperance | Montegnee | Belgium | 4420 | |
| 2 | Clinical Hospital Center Split | Split | Croatia | 21000 | |
| 3 | University Children Hospital | Brno | Czech Republic | 662 63 | |
| 4 | Aalborg Hospital | Aalborg | Denmark | DK-9000 | |
| 5 | Universtiy Hospital of Aarhus | Aarhus | Denmark | 8200 | |
| 6 | Odense University Hospital | Odense | Denmark | DK-5000 | |
| 7 | Hopital Nord Amiens | Amiens | France | 80054 | |
| 8 | CHR de Besancon - Hopital Saint-Jacques | Besancon | France | 25030 | |
| 9 | CHU de Bordeaux - Hopital Pellegrin | Bordeaux | France | 33076 | |
| 10 | C.H.U. de Brest | Brest | France | 29200 | |
| 11 | Centre Oscar Lambret | Lille | France | 59020 | |
| 12 | Centre Hospitalier Regional de Lille | Lille | France | 59037 | |
| 13 | Centre Hospital Regional Universitaire de Limoges | Limoges | France | 87042 | |
| 14 | Centre Leon Berard | Lyon | France | 69373 | |
| 15 | Hopital d'Enfants de la Timone | Marseille | France | 13385 | |
| 16 | Hopital Arnaud de Villeneuve | Montpellier | France | 34295 | |
| 17 | CHR Hotel Dieu | Nantes | France | 44093 | |
| 18 | Centre Antoine Lacassagne | Nice | France | 06189 | |
| 19 | C.H.U. Saint Etienne Hospital Nord | Saint Etienne | France | 42055 | |
| 20 | Hopitaux Universitaire de Strasbourg | Strasbourg | France | 67091 | |
| 21 | Centre Hospitalier Regional de Purpan | Toulouse | France | 31059 | |
| 22 | C.H. Bastien de Clocheville | Tours | France | 3700 | |
| 23 | CHRU de Nancy - Hopitaux de Brabois | Vandoeuvre-Les-Nancy | France | 54511 | |
| 24 | Children's Hospital A. Kyriakou | Athens | Greece | 617 | |
| 25 | Ospedale Raffaele Silvestrini | San Sisto Perugia | Italy | 06100 | |
| 26 | Academisch Medisch Centrum | Amsterdam | Netherlands | 1105 AZ | |
| 27 | Academisch Ziekenhuis der Vrije Universiteit | Amsterdam | Netherlands | 1117 MB | |
| 28 | Emma Kinderziekenhuis | Amsterdam | Netherlands | NL-1100 DE | |
| 29 | University Medical Center Nijmegen | Nijmegen | Netherlands | NL-6252 HB | |
| 30 | Haukeland Hospital - University of Bergen | Bergen | Norway | N-5021 | |
| 31 | University of Tromso | Tromso | Norway | N-9037 | |
| 32 | Regionsykehuset & University Hospital | Trondheim | Norway | 7006 | |
| 33 | Wroclaw Medical University | Wroclaw (Breslau) | Poland | 50-367 | |
| 34 | Hospital Escolar San Joao | Porto | Portugal | 4200 | |
| 35 | Pediatricna Klinika | Ljubljana | Slovenia | 61000 | |
| 36 | Hospital General Universitari Vall d'Hebron | Barcelona | Spain | 08035 | |
| 37 | Centro Medico "La Zarzuela" | Madrid | Spain | 28023 | |
| 38 | Hospital Universitario LaPaz | Madrid | Spain | 28046 | |
| 39 | Hospital Materno-Infantil | Malaga | Spain | 29011 | |
| 40 | Hospital General de Galicia | Santiago de Compostela | Spain | 15705 | |
| 41 | Hospital Des Cruces | Vizcaya | Spain | 48 | |
| 42 | Lund University Hospital | Lund | Sweden | SE-22-1 85 | |
| 43 | Karolinska Hospital | Stockholm | Sweden | S-171 76 | |
| 44 | Tawam Hospital | Abu Dhabi | United Arab Emirates |
Sponsors and Collaborators
- University of Leicester
Investigators
- Study Chair: Jan DeKraker, MD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study Documents (Full-Text)
None provided.More Information
Publications
- Furtwängler R, Nourkami N, Alkassar M, von Schweinitz D, Schenk JP, Rübe 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.
- Luithle T, Szavay P, Furtwängler 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.
- 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.
- Szavay P, Luithle T, Graf N, Furtwängler 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.
- 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.
- 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.
- Warmann SW, Furtwängler 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.
- Warmann SW, Nourkami N, Frühwald 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.
- CDR0000066948
- SIOP-93-01
- EU-98064