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

Primary Purpose

Kidney Cancer

Status

Unknown status

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

dactinomycin

vincristine sulfate

conventional surgery

About this trial

This is an interventional treatment trial for Kidney Cancer focused on measuring stage I Wilms tumor

Eligibility Criteria

undefined - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00003804

First Posted

November 1, 1999

Last Updated

June 23, 2014

Sponsor

University of Leicester

1. Study Identification

Unique Protocol Identification Number

NCT00003804

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 Type

Interventional

2. Study Status

Record Verification Date

April 2012

Overall Recruitment Status

Unknown status

Study Start Date

July 1993 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Leicester

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kidney Cancer

Keywords

stage I Wilms tumor

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Allocation

Randomized

Enrollment

350 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

dactinomycin

Intervention Type

Drug

Intervention Name(s)

vincristine sulfate

Intervention Type

Procedure

Intervention Name(s)

conventional surgery

10. Eligibility

Sex

All

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jan DeKraker, MD

Organizational Affiliation

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

Official's Role

Study Chair

Facility Information:

Facility Name

Clinique de l'Esperance

City

Montegnee

ZIP/Postal Code

4420

Country

Belgium

Facility Name

Clinical Hospital Center Split

City

Split

ZIP/Postal Code

21000

Country

Croatia

Facility Name

University Children Hospital

City

Brno

ZIP/Postal Code

662 63

Country

Czech Republic

Facility Name

Aalborg Hospital

City

Aalborg

ZIP/Postal Code

DK-9000

Country

Denmark

Facility Name

Universtiy Hospital of Aarhus

City

Aarhus

ZIP/Postal Code

8200

Country

Denmark

Facility Name

Odense University Hospital

City

Odense

ZIP/Postal Code

DK-5000

Country

Denmark

Facility Name

Hopital Nord Amiens

City

Amiens

ZIP/Postal Code

80054

Country

France

Facility Name

CHR de Besancon - Hopital Saint-Jacques

City

Besancon

ZIP/Postal Code

25030

Country

France

Facility Name

CHU de Bordeaux - Hopital Pellegrin

City

Bordeaux

ZIP/Postal Code

33076

Country

France

Facility Name

C.H.U. de Brest

City

Brest

ZIP/Postal Code

29200

Country

France

Facility Name

Centre Oscar Lambret

City

Lille

ZIP/Postal Code

59020

Country

France

Facility Name

Centre Hospitalier Regional de Lille

City

Lille

ZIP/Postal Code

59037

Country

France

Facility Name

Centre Hospital Regional Universitaire de Limoges

City

Limoges

ZIP/Postal Code

87042

Country

France

Facility Name

Centre Leon Berard

City

Lyon

ZIP/Postal Code

69373

Country

France

Facility Name

Hopital d'Enfants de la Timone

City

Marseille

ZIP/Postal Code

13385

Country

France

Facility Name

Hopital Arnaud de Villeneuve

City

Montpellier

ZIP/Postal Code

34295

Country

France

Facility Name

CHR Hotel Dieu

City

Nantes

ZIP/Postal Code

44093

Country

France

Facility Name

Centre Antoine Lacassagne

City

Nice

ZIP/Postal Code

06189

Country

France

Facility Name

C.H.U. Saint Etienne Hospital Nord

City

Saint Etienne

ZIP/Postal Code

42055

Country

France

Facility Name

Hopitaux Universitaire de Strasbourg

City

Strasbourg

ZIP/Postal Code

67091

Country

France

Facility Name

Centre Hospitalier Regional de Purpan

City

Toulouse

ZIP/Postal Code

31059

Country

France

Facility Name

C.H. Bastien de Clocheville

City

Tours

ZIP/Postal Code

3700

Country

France

Facility Name

CHRU de Nancy - Hopitaux de Brabois

City

Vandoeuvre-Les-Nancy

ZIP/Postal Code

54511

Country

France

Facility Name

Children's Hospital A. Kyriakou

City

Athens

ZIP/Postal Code

617

Country

Greece

Facility Name

Ospedale Raffaele Silvestrini

City

San Sisto Perugia

ZIP/Postal Code

06100

Country

Italy

Facility Name

Academisch Medisch Centrum

City

Amsterdam

ZIP/Postal Code

1105 AZ

Country

Netherlands

Facility Name

Academisch Ziekenhuis der Vrije Universiteit

City

Amsterdam

ZIP/Postal Code

1117 MB

Country

Netherlands

Facility Name

Emma Kinderziekenhuis

City

Amsterdam

ZIP/Postal Code

NL-1100 DE

Country

Netherlands

Facility Name

University Medical Center Nijmegen

City

Nijmegen

ZIP/Postal Code

NL-6252 HB

Country

Netherlands

Facility Name

Haukeland Hospital - University of Bergen

City

Bergen

ZIP/Postal Code

N-5021

Country

Norway

Facility Name

University of Tromso

City

Tromso

ZIP/Postal Code

N-9037

Country

Norway

Facility Name

Regionsykehuset & University Hospital

City

Trondheim

ZIP/Postal Code

7006

Country

Norway

Facility Name

Wroclaw Medical University

City

Wroclaw (Breslau)

ZIP/Postal Code

50-367

Country

Poland

Facility Name

Hospital Escolar San Joao

City

Porto

ZIP/Postal Code

4200

Country

Portugal

Facility Name

Pediatricna Klinika

City

Ljubljana

ZIP/Postal Code

61000

Country

Slovenia

Facility Name

Hospital General Universitari Vall d'Hebron

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Centro Medico "La Zarzuela"

City

Madrid

ZIP/Postal Code

28023

Country

Spain

Facility Name

Hospital Universitario LaPaz

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Hospital Materno-Infantil

City

Malaga

ZIP/Postal Code

29011

Country

Spain

Facility Name

Hospital General de Galicia

City

Santiago de Compostela

ZIP/Postal Code

15705

Country

Spain

Facility Name

Hospital Des Cruces

City

Vizcaya

ZIP/Postal Code

Country

Spain

Facility Name

Lund University Hospital

City

Lund

ZIP/Postal Code

SE-22-1 85

Country

Sweden

Facility Name

Karolinska Hospital

City

Stockholm

ZIP/Postal Code

S-171 76

Country

Sweden

Facility Name

Tawam Hospital

City

Abu Dhabi

Country

United Arab Emirates

12. IPD Sharing Statement

Citations:

PubMed Identifier

22238153

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.

Results Reference

background

PubMed Identifier

22513793

Citation

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.

Results Reference

background

PubMed Identifier

21509706

Citation

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.

Results Reference

background

PubMed Identifier

21370404

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.

Results Reference

background

PubMed Identifier

21670612

Citation

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.

Results Reference

background

PubMed Identifier

18095319

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. doi: 10.1002/pbc.21389.

Results Reference

background

PubMed Identifier

17162067

Citation

Luithle T, Szavay P, Furtwangler 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. doi: 10.1016/j.juro.2006.09.011.

Results Reference

background

PubMed Identifier

16410128

Citation

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.

Results Reference

background

PubMed Identifier

10463285

Citation

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. doi: 10.1007/s100249900033.

Results Reference

result

PubMed Identifier

19300220

Citation

Fuchs J, Kienecker K, Furtwangler R, Warmann SW, Burger D, Thurhoff 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. 2009 Apr;249(4):666-71. doi: 10.1097/SLA.0b013e31819ed92b.

Results Reference

result

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.

Results Reference

result

PubMed Identifier

17084075

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. Eur J Cancer. 2007 Jan;43(1):131-6. doi: 10.1016/j.ejca.2006.08.033. Epub 2006 Nov 2.

Results Reference

result

PubMed Identifier

15542800

Citation

Reinhard H, Aliani S, Ruebe C, Stockle 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. doi: 10.1200/JCO.2004.12.099.

Results Reference

result

PubMed Identifier

15175957

Citation

Reinhard H, Semler O, Burger D, Bode U, Flentje M, Gobel U, Gutjahr P, Leuschner I, Maass E, Niggli F, Scheel-Walter HG, Stockle M, Thuroff JW, Troger J, Weirich A, von Schweinitz D, Zoubek A, Graf N. Results of the SIOP 93-01/GPOH trial and study for the treatment of patients with unilateral nonmetastatic Wilms Tumor. Klin Padiatr. 2004 May-Jun;216(3):132-40. doi: 10.1055/s-2004-822625.

Results Reference

result

PubMed Identifier

20582946

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.

Results Reference

result

PubMed Identifier

18811224

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):111-5. doi: 10.2350/08-03-0432.1. Epub 2008 Sep 23.

Results Reference

result

Learn more about this trial

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

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

Kidney Cancer

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial