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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was Recruiting

Sponsor:

Collaborators:

Societe Francaise Oncologie Pediatrique

Children's Cancer and Leukaemia Group

Gesellschaft fur Padiatrische Onkologie und Hamatologie - Germany

Information provided by:

National Cancer Institute (NCI)

ClinicalTrials.gov Identifier:

NCT00047138

First received: October 3, 2002

Last updated: May 1, 2012

Last verified: June 2009

History of Changes

Purpose

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.

Condition	Intervention	Phase
Kidney Cancer	Biological: dactinomycin Drug: carboplatin Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Drug: vincristine sulfate Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: radiation therapy	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Primary Purpose: Treatment
Official Title:	Nephroblastoma (Wilms Tumour) Clinical Trial And Study

Resource links provided by NLM:

MedlinePlus related topics: Cancer Kidney Cancer Wilms' Tumor

Drug Information available for: Cyclophosphamide Dactinomycin Vincristine sulfate Doxorubicin Doxorubicin hydrochloride Etoposide Carboplatin Etoposide phosphate

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Event-free survival [ Designated as safety issue: No ]
Treatment failure, in terms of disease recurrence or death [ Designated as safety issue: No ]

Estimated Enrollment:	350
Study Start Date:	January 2001

Show Detailed Description

Eligibility

Ages Eligible for Study:	up to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00047138

Locations

France
Institut Gustave Roussy	Recruiting
Villejuif, France, 94805 CEDEX
Contact: Francois Pein, MD 33-1-4211-4339 pein@igr.fr
Germany
Universitaetsklinikum des Saarlandes	Recruiting
Homburg, Germany, 66421
Contact: Norbert Graf 49-6841-162-4000
Netherlands
Academisch Medisch Centrum at University of Amsterdam	Recruiting
Amsterdam, Netherlands, 1100 DE
Contact: Jan DeKraker, MD 31-20-566-9111 j.dekraker@amc.uva.nl
United Kingdom
Royal Marsden - Surrey	Recruiting
Sutton, England, United Kingdom, SM2 5PT
Contact: Kathy Pritchard-Jones, MD 44-20-8661-3452 ext 3498

Sponsors and Collaborators

University Hospitals, Leicester

Societe Francaise Oncologie Pediatrique

Children's Cancer and Leukaemia Group

Gesellschaft fur Padiatrische Onkologie und Hamatologie - Germany

Investigators

Study Chair:	Jan DeKraker, MD	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study Chair:	Francois Pein, MD	Institut Gustave Roussy
Study Chair:	Kathy Pritchard-Jones, MD	Royal Marsden NHS Foundation Trust
Study Chair:	Norbert Graf	Universitaetsklinikum des Saarlandes

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Smets AM, Tinteren HV, Bergeron C, Camargo BD, Graf N, Pritchard-Jones K, Kraker JD. The contribution of chest CT-scan at diagnosis in children with unilateral Wilms' tumour. Results of the SIOP 2001 study. Eur J Cancer. 2011 Jun 22; [Epub ahead of print]

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 Mar 23; [Epub ahead of print]

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; On behalf of the 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 Feb 19; [Epub ahead of print]

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 18. [Epub ahead of print]

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 Apr 20; [Epub ahead of print]

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. 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.

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.

ClinicalTrials.gov Identifier:	NCT00047138 History of Changes
Other Study ID Numbers:	CDR0000257531, SIOP-WT-2001, SFOP-SIOP-WT-2001, CCLG-SIOP-WT-2001, GPOH-GERMANY-SIOP-WT-2001, EU-20208
Study First Received:	October 3, 2002
Last Updated:	May 1, 2012
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

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

Additional relevant MeSH terms:

Carcinoma, Renal Cell
Kidney Neoplasms
Wilms Tumor
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplasms, Complex and Mixed
Neoplastic Syndromes, Hereditary

Genetic Diseases, Inborn
Dactinomycin
Doxorubicin
Cyclophosphamide
Etoposide
Vincristine
Carboplatin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on May 22, 2013

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