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

This study is currently recruiting participants.

Verified by National Cancer Institute (NCI), April 2008

Sponsors and Collaborators:	University Hospitals, Leicester 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

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	Drug: carboplatin Drug: cyclophosphamide Drug: dactinomycin Drug: doxorubicin hydrochloride Drug: etoposide Drug: vincristine sulfate Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy Procedure: radiation therapy	Phase III

MedlinePlus related topics: Cancer Kidney Cancer Wilms' Tumor

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
Official Title:	Nephroblastoma (Wilms Tumour) Clinical Trial And Study

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, England
Royal Marsden - Surrey	Recruiting
Sutton, England, United Kingdom, SM2 5PT
Contact: Kathy Pritchard-Jones, MD 44-20-8661-3498

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 - Surrey
Study Chair:	Norbert Graf	Universitaetsklinikum des Saarlandes

More Information

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

Publications:

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.

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:	August 23, 2008
ClinicalTrials.gov Identifier:	NCT00047138
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

Study placed in the following topic categories:

Wilms' tumor
Vincristine
Urogenital Neoplasms
Carboplatin
Cyclophosphamide
Renal cancer
Urologic Neoplasms
Kidney cancer
Etoposide phosphate
Doxorubicin
Carcinoma
Neoplastic Syndromes, Hereditary

Urologic Diseases
Genetic Diseases, Inborn
Dactinomycin
Kidney Neoplasms
Carcinoma, Renal Cell
Wilms Tumor
Kidney Diseases
Adenocarcinoma
Etoposide
Urinary tract neoplasm
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Anti-Bacterial Agents
Neoplasms by Site
Therapeutic Uses
Alkylating Agents
Nucleic Acid Synthesis Inhibitors
Neoplasms by Histologic Type
Mitosis Modulators

Enzyme Inhibitors
Antimitotic Agents
Immunosuppressive Agents
Pharmacologic Actions
Protein Synthesis Inhibitors
Neoplasms
Tubulin Modulators
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Neoplasms, Complex and Mixed

ClinicalTrials.gov processed this record on January 15, 2009