Clinical trial · Interventional
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
NCT00379340CI-TRIAL-00119227completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage III Kidney Wilms Tumor | Kidney Wilms Tumor | CURATED_BROADER | 0.78 |
| Stage IV Kidney Wilms Tumor | Kidney Wilms Tumor | CURATED_BROADER | 0.78 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3-Dimensional Conformal Radiation Therapy | Radiation | — | UNRESOLVED |
| Conventional Surgery | Procedure | — | UNRESOLVED |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Dactinomycin | Biological | Dactinomycin | ALIAS |
| Doxorubicin Hydrochloride | Drug | Doxorubicin | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| Vincristine Sulfate Liposome | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (chemotherapy, surgery, radiotherapy)
- description
- REGIMEN DD4A (weeks 1-6): Patients receive dactinomycin IV; vincristine IV; and doxorubicin hydrochloride IV. Patients with pulmonary and extra-pulmonary metastases at diagnosis undergo radiotherapy. 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. REGIMEN DD4A (weeks 7-25): Patients receive dactinomycin IV; vincristine IV; and doxorubicin hydrochloride IV. REGIMEN M (weeks 7-31): Patients receive cyclophosphamide IV; vincristine IV; and dactinomycin IV and doxorubicin hydrochloride IV. Patients with pulmonary metastases only who are SIR also undergo whole lung radiotherapy.
- interventionNames
- Radiation: 3-Dimensional Conformal Radiation Therapy
- Procedure: Conventional Surgery
- Drug: Cyclophosphamide
- Biological: Dactinomycin
- Drug: Doxorubicin Hydrochloride
- Drug: Etoposide
- Drug: Vincristine Sulfate Liposome
Primary outcomes (3)
- measure
- Event Free Survival Probability
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 29 Years
Show eligibility criteria text
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
References
Publications (4)
- DERIVEDBenedetti DJ, Varela CR, Renfro LA, Tornwall B, Dix DB, Ehrlich PF, Glick RD, Kalapurakal J, Perlman E, Gratias E, Seibel NL, Geller JI, Khanna G, Malogolowkin M, Grundy P, Fernandez CV, Dome JS, Mullen EA. Treatment of children with favorable histology Wilms tumor with extrapulmonary metastases: A report from the COG studies AREN0533 and AREN03B2 and NWTSG study NWTS-5. Cancer. 2024 Mar 15;130(6):947-961. doi: 10.1002/cncr.35099. Epub 2023 Nov 7. PMID 37933882
- DERIVEDMadanat-Harjuoja LM, Renfro LA, Klega K, Tornwall B, Thorner AR, Nag A, Dix D, Dome JS, Diller LR, Fernandez CV, Mullen EA, Crompton BD. Circulating Tumor DNA as a Biomarker in Patients With Stage III and IV Wilms Tumor: Analysis From a Children's Oncology Group Trial, AREN0533. J Clin Oncol. 2022 Sep 10;40(26):3047-3056. doi: 10.1200/JCO.22.00098. Epub 2022 May 17. PMID 35580298
- DERIVEDDix DB, Fernandez CV, Chi YY, Mullen EA, Geller JI, Gratias EJ, Khanna G, Kalapurakal JA, Perlman EJ, Seibel NL, Ehrlich PF, Malogolowkin M, Anderson J, Gastier-Foster J, Shamberger RC, Kim Y, Grundy PE, Dome JS; AREN0532 and AREN0533 study committees. Augmentation of Therapy for Combined Loss of Heterozygosity 1p and 16q in Favorable Histology Wilms Tumor: A Children's Oncology Group AREN0532 and AREN0533 Study Report. J Clin Oncol. 2019 Oct 20;37(30):2769-2777. doi: 10.1200/JCO.18.01972. Epub 2019 Aug 26. PMID 31449468
- DERIVEDDix DB, Seibel NL, Chi YY, Khanna G, Gratias E, Anderson JR, Mullen EA, Geller JI, Kalapurakal JA, Paulino AC, Perlman EJ, Ehrlich PF, Malogolowkin M, Gastier-Foster JM, Wagner E, Grundy PE, Fernandez CV, Dome JS. Treatment of Stage IV Favorable Histology Wilms Tumor With Lung Metastases: A Report From the Children's Oncology Group AREN0533 Study. J Clin Oncol. 2018 Jun 1;36(16):1564-1570. doi: 10.1200/JCO.2017.77.1931. Epub 2018 Apr 16. PMID 29659330