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

Kidney Cancer Clinical Trial

Official title:

Nephroblastoma Clinical Trial and Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00003804
• Other study ID #: CDR0000066948
• Secondary ID: SIOP-93-01EU-980
• Status: Active, not recruiting
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: June 23, 2014
• Start date: July 1993

Study information

• Verified date: April 2012
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 350
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Cancer

Intervention

Biological:
• dactinomycin

Drug:
• vincristine sulfate

Procedure:
• conventional surgery

Locations

Country	Name	City	State
Belgium	Clinique de l'Esperance	Montegnee
Croatia	Clinical Hospital Center Split	Split
Czech Republic	University Children Hospital	Brno
Denmark	Aalborg Hospital	Aalborg
Denmark	Universtiy Hospital of Aarhus	Aarhus
Denmark	Odense University Hospital	Odense
France	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 Hospitalier Regional de Lille	Lille
France	Centre Oscar Lambret	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
Greece	Children's Hospital A. Kyriakou	Athens
Italy	Ospedale Raffaele Silvestrini	San Sisto Perugia
Netherlands	Academisch Medisch Centrum	Amsterdam
Netherlands	Academisch Ziekenhuis der Vrije Universiteit	Amsterdam
Netherlands	Emma Kinderziekenhuis	Amsterdam
Netherlands	University Medical Center Nijmegen	Nijmegen
Norway	Haukeland Hospital - University of Bergen	Bergen
Norway	University of Tromso	Tromso
Norway	Regionsykehuset & University Hospital	Trondheim
Poland	Wroclaw Medical University	Wroclaw (Breslau)
Portugal	Hospital Escolar San Joao	Porto
Slovenia	Pediatricna Klinika	Ljubljana
Spain	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
Sweden	Lund University Hospital	Lund
Sweden	Karolinska Hospital	Stockholm
United Arab Emirates	Tawam Hospital	Abu Dhabi

Sponsors (1)

Lead Sponsor	Collaborator
University of Leicester

Countries where clinical trial is conducted

Belgium,  Croatia,  Czech Republic,  Denmark,  France,  Greece,  Italy,  Netherlands,  Norway,  Poland,  Portugal,  Slovenia,  Spain,  Sweden,  United Arab Emirates, 

References & Publications (16)

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. — View Citation

Fuchs J, Kienecker K, Furtwängler R, Warmann SW, Bürger D, Thürhoff 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. — View Citation

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. — View Citation

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.

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. — View Citation

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. — View Citation

Reinhard H, Aliani S, Ruebe C, Stöckle 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. — View Citation

Reinhard H, Semler O, Bürger D, Bode U, Flentje M, Göbel U, Gutjahr P, Leuschner I, Maass E, Niggli F, Scheel-Walter HG, Stöckle M, Thüroff JW, Tröger J, Weirich A, von Schweinitz D, Zoubek A, Graf N. Results of the SIOP 93-01/GPOH trial and study for the — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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) — View Citation

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. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references