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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2009 by National Cancer Institute (NCI) ( University of Leicester ).
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00047138
First Posted: January 27, 2003
Last Update Posted: June 24, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Societe Francaise Oncologie Pediatrique
Children's Cancer and Leukaemia Group
Gesellschaft fur Padiatrische Onkologie und Hamatologie - Germany
Information provided by (Responsible Party):
National Cancer Institute (NCI) ( University of Leicester )
  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:


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

Primary Outcome Measures:
  • Event-free survival
  • Treatment failure, in terms of disease recurrence or death

Estimated Enrollment: 350
Study Start Date: January 2001
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 of 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 Gustave Roussy, Cancer Campus, Grand Paris
Study Chair: Kathy Pritchard-Jones, MD Royal Marsden NHS Foundation Trust
Study Chair: Norbert Graf Universitaetsklinikum des Saarlandes
  More Information

Publications:

Responsible Party: University of Leicester
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
First Submitted: October 3, 2002
First Posted: January 27, 2003
Last Update Posted: June 24, 2014
Last Verified: June 2009

Keywords provided by National Cancer Institute (NCI) ( University of Leicester ):
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:
Kidney Neoplasms
Carcinoma, Renal Cell
Wilms Tumor
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Kidney Diseases
Urologic Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Complex and Mixed
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn
Cyclophosphamide
Liposomal doxorubicin
Carboplatin
Doxorubicin
Etoposide
Vincristine
Dactinomycin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action