Combination Chemotherapy With or Without Radiation Therapy in Treating Young Patients With Newly Diagnosed Stage III or Stage IV Wilms' Tumor

Not Recruiting

Trial ID: NCT00379340


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.

Official Title

Treatment of Newly Diagnosed Higher Risk Favorable Histology Wilms Tumors

Stanford Investigator(s)


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

   - 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

   - 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


biological: dactinomycin

drug: cyclophosphamide

drug: doxorubicin hydrochloride

drug: etoposide

procedure: conventional surgery

radiation: 3-dimensional conformal radiation therapy

drug: Vincristine Sulfate Liposome

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Peds Hem/Onc CRAs

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