Chemotherapy Before and After Surgery in Treating Children With Wilm's Tumor

NCT00047138 | Unknown Phase 3

• 6 other identifiers: CDR0000257531SIOP-WT-2001SFOP-SIOP-WT-2001CCLG-SIOP-WT-2001GPOH-GERMANY-SIOP-WT-2001EU-20208
• Study Type: interventional
• Target: 350
• Locations: 4 countries
• Sites: 4

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving combination chemotherapy before surgery may shrink the tumor so it can be removed during surgery. Giving more chemotherapy after surgery may kill any remaining tumor cells. It is not yet known which chemotherapy regimen after surgery is most effective in treating Wilm's tumor. PURPOSE: Phase III trial to study the effectiveness of chemotherapy before and after surgery in treating children who have Wilm's tumor.

Conditions

Kidney Cancer

Keywords

blastema predominant Wilms tumor; epithelial predominant Wilms tumor; mixed cell type Wilms tumor; stage I Wilms tumor; stage II Wilms tumor; stage III Wilms tumor; stage IV Wilms tumor; stage V Wilms tumor; stromal predominant Wilms tumor

Outcome Measures

Primary Outcomes (2)

• Event-free survival

• Treatment failure, in terms of disease recurrence or death

Interventions

dactinomycin BIOLOGICAL

carboplatin DRUG

cyclophosphamide DRUG

doxorubicin hydrochloride DRUG

etoposide DRUG

vincristine sulfate DRUG

adjuvant therapy PROCEDURE

conventional surgery PROCEDURE

neoadjuvant therapy PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

DISEASE CHARACTERISTICS: * Diagnosis of one of the following: * Localized disease * Unilateral tumor * Histologically confirmed Wilms' tumor OR * Clinical and ultrasonic characteristics of nephroblastoma * No metastasis * Age 6 months to 17 years at diagnosis * No prior anticancer therapy * Metastatic disease * Unilateral tumor * Histologically confirmed Wilms' tumor OR * Clinical and ultrasonic characteristics of nephroblastoma * Age 18 and under * No prior anticancer therapy * Simultaneous bilateral tumors * No metastases * No recurrent disease * No other renal tumors PATIENT CHARACTERISTICS: Age * See Disease Characteristics * 18 and under Performance status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Other * No social or geographical reasons that would preclude study * No other associated pathology that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy Endocrine therapy * Not specified Radiotherapy * No prior radiotherapy Surgery * No prior surgery * No requirement for emergency or immediate surgery for any reason

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Leicester: lead
• Societe Francaise Oncologie Pediatrique: collaborator
• Children's Cancer and Leukaemia Group: collaborator
• German Society for Pediatric Oncology and Hematology GPOH gGmbH: collaborator

Study Sites (4)

Institut Gustave Roussy

Villejuif, 94805 CEDEX, France

RECRUITING

Universitaetsklinikum des Saarlandes

Homburg, 66421, Germany

RECRUITING

Academisch Medisch Centrum at University of Amsterdam

Amsterdam, 1100 DE, Netherlands

RECRUITING

Royal Marsden - Surrey

Sutton, England, SM2 5PT, United Kingdom

RECRUITING

Related Publications (9)

• Warmann SW, Nourkami N, Fruhwald 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.

  PMID: 22513793 BACKGROUND

• Furtwangler R, Nourkami N, Alkassar M, von Schweinitz D, Schenk JP, Rube 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.

  PMID: 21509706 BACKGROUND

• 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.

  PMID: 21370404 BACKGROUND

• Warmann SW, Furtwangler 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.

  PMID: 21670612 BACKGROUND

• Szavay P, Luithle T, Graf N, Furtwangler 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. doi: 10.1016/j.jpedsurg.2005.10.021.

  PMID: 16410128 BACKGROUND

• Smets AM, van Tinteren H, Bergeron C, De Camargo B, Graf N, Pritchard-Jones K, de Kraker J. The contribution of chest CT-scan at diagnosis in children with unilateral Wilms' tumour. Results of the SIOP 2001 study. Eur J Cancer. 2012 May;48(7):1060-5. doi: 10.1016/j.ejca.2011.05.025. Epub 2011 Jun 22.

  PMID: 21703848 RESULT

• Williams RD, Al-Saadi R, Chagtai T, Popov S, Messahel B, Sebire N, Gessler M, Wegert J, Graf N, Leuschner I, Hubank M, Jones C, Vujanic G, Pritchard-Jones K; Children's Cancer and Leukaemia Group; SIOP Wilms' Tumour Biology Group. Subtype-specific FBXW7 mutation and MYCN copy number gain in Wilms' tumor. Clin Cancer Res. 2010 Apr 1;16(7):2036-45. doi: 10.1158/1078-0432.CCR-09-2890. Epub 2010 Mar 23.

  PMID: 20332316 RESULT

• Messahel B, Williams R, Ridolfi A, A'hern R, Warren W, Tinworth L, Hobson R, Al-Saadi R, Whyman G, Brundler MA, Kelsey A, Sebire N, Jones C, Vujanic G, Pritchard-Jones K; Children's Cancer and Leukaemia Group (CCLG). Allele loss at 16q defines poorer prognosis Wilms tumour irrespective of treatment approach in the UKW1-3 clinical trials: a Children's Cancer and Leukaemia Group (CCLG) Study. Eur J Cancer. 2009 Mar;45(5):819-26. doi: 10.1016/j.ejca.2009.01.005. Epub 2009 Feb 21.

  PMID: 19231157 RESULT

• Sudour-Bonnange H, van Tinteren H, Ramirez-Villar GL, Godzinski J, Irtan S, Gessler M, Chowdhury T, Audry G, Fuchs J, Powis M, van de Ven CP, Okoye B, Smeulders N, Vujanic GM, Verschuur A, L'Hermine-Coulomb A, de Camargo B, de Aguirre Neto JC, Schenk JP, van den Heuvel-Eibrink MM, Pritchard-Jones K, Graf N, Bergeron C, Furtwangler R. Characteristics and outcome of synchronous bilateral Wilms tumour in the SIOP WT 2001 Study: Report from the SIOP Renal Tumour Study Group (SIOP-RTSG). Br J Cancer. 2024 Oct;131(6):972-981. doi: 10.1038/s41416-024-02799-0. Epub 2024 Jul 30.

  PMID: 39080350 DERIVED

MeSH Terms

Conditions

Kidney Neoplasms; Wilms Tumor

Interventions

Dactinomycin; Carboplatin; Cyclophosphamide; Doxorubicin; Etoposide; Vincristine; Chemotherapy, Adjuvant; Neoadjuvant Therapy; Radiotherapy

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Coordination Complexes; Organic Chemicals; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Aminoglycosides; Glycosides; Carbohydrates; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Indolizidines; Indolizines; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Jan DeKraker, MD

  Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  STUDY CHAIR

• Francois Pein, MD

  Gustave Roussy, Cancer Campus, Grand Paris

  STUDY CHAIR

• Kathy Pritchard-Jones, MD

  Royal Marsden NHS Foundation Trust

  STUDY CHAIR

• Norbert Graf

  Universitaetsklinikum des Saarlandes

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2002
• First Posted: January 27, 2003
• Study Start: January 1, 2001
• Last Updated: June 24, 2014

Record last verified: 2009-06

Locations

DE (1); NL (1); GB (1); FR (1)