Trial record 1 of 1 for:    AREN0533
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Combination Chemotherapy With or Without Radiation Therapy in Treating Young Patients With Newly Diagnosed Stage III or Stage IV Wilms' Tumor

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00379340
First received: September 19, 2006
Last updated: June 18, 2013
Last verified: June 2013

September 19, 2006
June 18, 2013
February 2007
July 2016   (final data collection date for primary outcome measure)
  • EFS of patients with stage IV and rapidly completely responding (RCR) lung metastases [ Time Frame: At 4 years ] [ Designated as safety issue: No ]
    The methods of Woolson to compare the results to the fixed null outcomes as defined above and using an O'Brien-Fleming boundary (truncated at 3 standard deviations) will be used.
  • EFS of patients with stage IV and slow incomplete response (SIR) of lung metastases [ Time Frame: At 4 years ] [ Designated as safety issue: No ]
    The methods of Woolson to compare the results to the fixed null outcomes as defined above and using an O'Brien-Fleming boundary (truncated at 3 standard deviations) will be used.
  • EFS of patients with stage IV, non lung disease only and stage III/IV [ Time Frame: At 4 years ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00379340 on ClinicalTrials.gov Archive Site
Correlate between the burden of pulmonary metastatic disease with outcome in patients with stage IV FH Wilms' tumor [ Time Frame: At 4 years ] [ Designated as safety issue: No ]
CT scans of the abdomen and of the chest will be submitted in digital format through QARC (chest X-rays will not be requested) and reviewed and classified prospectively. Tumor burden will be compared with relapse-free survival to determine whether pulmonary tumor burden is a prognostic factor
Not Provided
Not Provided
Not Provided
 
Combination Chemotherapy With or Without Radiation Therapy in Treating Young Patients With Newly Diagnosed Stage III or Stage IV Wilms' Tumor
Treatment of Newly Diagnosed Higher Risk Favorable Histology Wilms Tumors

This phase III trial is studying how well combination chemotherapy with or without radiation therapy works in treating young patients with newly diagnosed stage III or stage IV Wilms' tumor. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving more than one drug (combination chemotherapy) with or without radiation therapy may kill more tumor cells.

PRIMARY OBJECTIVES:

I. Determine the 4-year event-free survival (EFS) of patients with stage IV favorable histology (FH) Wilms' tumor with pulmonary metastases only who have complete resolution of pulmonary lesions without whole lung irradiation treated with DD4A chemotherapy comprising vincristine, dactinomycin, and doxorubicin hydrochloride.

II. Determine the 4-year EFS of these patients who do not have resolution of pulmonary metastases by week 6 treated with the addition of cyclophosphamide and etoposide to a modified-regimen DD4A (regimen M).

III. Determine the 4-year EFS of patients with stage III or IV FH Wilms' tumor with loss of heterozygosity for chromosomes 1p and 16q treated with regimen M.

SECONDARY OBJECTIVES:

I. Correlate the burden of pulmonary metastatic disease with outcome in patients with stage IV FH Wilms' tumor.

OUTLINE: This is a multicenter study.

REGIMEN DD4A (weeks 1-6): Patients receive dactinomycin IV over 1-5 minutes once in week 1; vincristine IV once in weeks 1-6; and doxorubicin hydrochloride IV over 15 minutes once in week 4 in the absence of disease progression or unacceptable toxicity. Patients with pulmonary and extra-pulmonary metastases at diagnosis undergo radiotherapy once daily beginning in week 1 and continuing for 5-14 days. After completion of DD4A chemotherapy (week 6), patients undergo evaluation. Patients with stage IV disease and pulmonary metastases only with no loss of heterozygosity (LOH) who are rapid complete responders (RCR) (i.e., pulmonary metastases disappear) proceed to regimen DD4A (weeks 7-25).

All other patients (i.e., patients with stage III or IV disease and LOH of both 1p and 16q; stage IV disease with pulmonary metastases only who are slow incomplete responders [SIR] [i.e., pulmonary metastases do not disappear]; or stage IV disease with nonpulmonary metastases or with nonpulmonary metastases in combination with pulmonary metastases) proceed to regimen M (weeks 7-31).

Patients with initially unresectable or incompletely resected tumors are reevaluated at week 6, and if resectable, undergo surgery and then proceed to either regimen DD4A or regimen M as described above.

REGIMEN DD4A (weeks 7-25): Patients receive dactinomycin IV over 1-5 minutes once in weeks 7, 13, 19, and 25; vincristine IV once in weeks 7-10, 13, 16, 19, 22, and 25; and doxorubicin hydrochloride IV over 15 minutes once in weeks 10, 16, and 22 in the absence of disease progression or unacceptable toxicity.

REGIMEN M (weeks 7-31): Patients receive cyclophosphamide IV over 1 hour and etoposide IV over 1 hour on days 1-5 in weeks 7, 10, 19, and 25; vincristine IV once in weeks 8, 9, 11, 12, 13, 16, 22, 28, and 31; and dactinomycin IV and doxorubicin hydrochloride IV over 15 minutes once in weeks 13, 16, 22, 28, and 31 in the absence of disease progression or unacceptable toxicity. Patients with pulmonary metastases only who are SIR also undergo whole lung radiotherapy once daily beginning in week 7 and continuing for 5-14 days.

NOTE: Patients who begin study treatment after undergoing resection of pulmonary metastases are treated according to regimen DD4A (weeks 1-25) and undergo whole lung radiotherapy for 5-14 days beginning in week 1.

After completion of study treatment, patients are followed periodically for 10 years.

Interventional
Phase 3
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Stage III Wilms Tumor
  • Stage IV Wilms Tumor
  • Drug: doxorubicin hydrochloride
    Given IV
    Other Names:
    • ADM
    • ADR
    • Adria
    • Adriamycin PFS
    • Adriamycin RDF
  • Drug: liposomal vincristine sulfate
    Given IV
    Other Names:
    • liposomal vincristine
    • Marqibo
    • vincristine liposomal
    • vincristine sulfate liposome injection
  • Procedure: conventional surgery
    Other Name: surgery, conventional
  • Radiation: 3-dimensional conformal radiation therapy
    Other Names:
    • 3D conformal radiation therapy
    • 3D-CRT
  • Biological: dactinomycin
    Given IV
    Other Names:
    • ACT-D
    • actinomycin C1
    • AD
    • Cosmegen
    • DACT
  • Drug: cyclophosphamide
    Given IV
    Other Names:
    • CPM
    • CTX
    • Cytoxan
    • Endoxan
    • Endoxana
  • Drug: etoposide
    Given IV
    Other Names:
    • EPEG
    • VP-16
    • VP-16-213
Experimental: Treatment (chemotherapy, surgery, radiotherapy)
REGIMEN DD4A (weeks 1-6): Patients receive dactinomycin IV; liposomal vincristine sulfate IV; and doxorubicin hydrochloride IV. Patients with pulmonary and extra-pulmonary metastases at diagnosis undergo 3-dimensional conformal radiation therapy. Patients with initially unresectable or incompletely resected tumors are reevaluated at week 6, and if resectable, undergo conventional surgery and then proceed to either regimen DD4A or regimen M. REGIMEN DD4A (weeks 7-25): Patients receive dactinomycin IV; liposomal vincristine sulfate IV; doxorubicin hydrochloride IV and etoposide. REGIMEN M (weeks 7-31): Patients receive cyclophosphamide IV; liposomal vincristine sulfate IV; dactinomycin IV; doxorubicin hydrochloride IV and etoposide. Patients with pulmonary metastases only who are SIR also undergo whole lung 3-dimensional conformal radiation therapy.
Interventions:
  • Drug: doxorubicin hydrochloride
  • Drug: liposomal vincristine sulfate
  • Procedure: conventional surgery
  • Radiation: 3-dimensional conformal radiation therapy
  • Biological: dactinomycin
  • Drug: cyclophosphamide
  • Drug: etoposide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
395
Not Provided
July 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Newly diagnosed Wilms' tumor meeting 1 of the following criteria:

    • Stage IV disease with favorable histology with or without loss of heterozygosity (LOH) for 1p and 16q
    • Stage III disease with favorable histology with LOH for 1p and 16q transferring from clinical trial COG-AREN0532
  • Patients must begin therapy within 14 days after surgery or biopsy, unless medically contraindicated
  • No bilateral Wilms' tumors (stage IV)

    • Patients should be referred to COG-AREN0534
  • Previously enrolled in clinical trial COG-AREN03B2
  • Karnofsky performance status (PS) 50-100% (for patients > 16 years of age) OR Lansky PS 50-100% (for patients ≤ 16 years of age)
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST or ALT < 2.5 times ULN
  • Shortening fraction ≥ 27% by echocardiogram OR ejection fraction ≥ 50% by radionuclide angiogram
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No prior tumor-directed chemotherapy or radiotherapy unless transferring from clinical trial COG-AREN0532 OR treatment for emergent issues, as medically indicated
  • No concurrent aprepitant
Both
up to 29 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada,   Israel,   New Zealand,   Puerto Rico,   Switzerland
 
NCT00379340
AREN0533, NCI-2009-00419, CDR0000496508, U10CA098543, COG-AREN0533
Yes
Children's Oncology Group
Children's Oncology Group
National Cancer Institute (NCI)
Principal Investigator: David Dix Children's Oncology Group
Children's Oncology Group
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP