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 (Responsible Party):
National Cancer Institute (NCI) ( University of Leicester )
ClinicalTrials.gov Identifier:
NCT00047138
First received: October 3, 2002
Last updated: June 23, 2014
Last verified: June 2009
  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):

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
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, see Learn About Clinical Studies.

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 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

Additional Information:
Publications:

Responsible Party: National Cancer Institute (NCI) ( 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
Study First Received: October 3, 2002
Last Updated: June 23, 2014
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:
Wilms Tumor
Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Genetic Diseases, Inborn
Kidney Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Complex and Mixed
Neoplasms, Glandular and Epithelial
Neoplastic Syndromes, Hereditary
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Cyclophosphamide
Dactinomycin
Doxorubicin
Liposomal doxorubicin
Vincristine
Alkylating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Phytogenic
Antirheumatic Agents

ClinicalTrials.gov processed this record on October 29, 2014