Phase 3
N=380
Combination Chemotherapy With or Without Radiation Therapy in Treating Young Patients With Newly Diagnosed Stage III or Stage IV Wilms' Tumor
Stage III Kidney Wilms Tumor · Stage IV Kidney Wilms Tumor
Bottom Line
View on ClinicalTrials.gov: NCT00379340 ↗Enrolled (actual)
380
Serious AEs
7.1%
Results posted
Jun 2017
Primary outcome: Primary: Event Free Survival Probability — 0.79 Probability
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 3-Dimensional Conformal Radiation Therapy (Radiation); Conventional Surgery (Procedure); Cyclophosphamide (Drug); Dactinomycin (Biological); Doxorubicin Hydrochloride (Drug); Etoposide (Drug); Vincristine Sulfate Liposome (Drug)
- Age
- Pediatric, Adult
- Sex
- All
- Sponsor
- Children's Oncology Group
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Event Free Survival Probability |
0.90; 0.73 | — |
| PRIMARY Event Free Survival (EFS) Probability |
0.89 | — |
| PRIMARY Event Free Survival Probability |
0.90; 0.73 | — |
| SECONDARY Event Free Survival Associated With the Burden of Pulmonary Metastatic Disease |
0.88; 0.82 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Patients must be less than 30 years of age at the time of diagnosis
- Prior to enrollment on AREN0533, all patients must have been enrolled on AREN03B2 for central pathology review. Stage III patients with LOH transferring from AREN0532 may be enrolled on this study. Eligible patients for AREN0533 must be:
- Newly diagnosed Stage IV favorable histology Wilms tumor with or without LOH 1p and 16q or
- Newly diagnosed Stage III favorable histology Wilms tumor with LOH for 1p and 16q transferring from AREN0532
- Patients with bilateral Wilms tumors (Stage V) are not eligible for AREN0533 and should be directed to AREN0534
- Patients must begin protocol therapy on AREN0533 by Day 14 after surgery or biopsy, unless medically contraindicated
- The Karnofsky performance status must be >= 50 for patients > 16 years of age and the Lansky performance status must be >= 50 for patients =< 16 years of age
- Patients cannot have had prior tumor-directed chemotherapy or radiotherapy except for patients transferring from AREN0532 or those treated for emergent issues, as medically indicated
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN) for age (must be submitted for central review by Day 7)
- Serum glutamic oxaloacetic transaminase (SGOT) aspartate aminotransferase (AST) or serum glutamic pyruvic transaminase (SGPT) alanine aminotransferase (ALT) < 2.5 x ULN for age (must be submitted for central review by Day 7)
- Shortening fraction ≥ 27% by echocardiogram OR ejection fraction ≥ 50% by radionuclide angiogram
- Female patients of childbearing age must have a negative pregnancy test
- Female patients who are lactating must agree to stop breast-feeding
- Sexually active patients of childbearing potential must agree to use effective contraception
Data sourced from ClinicalTrials.gov (NCT00379340). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.