Clinical trial · Interventional
Chemotherapy With or Without Surgery, Radiation Therapy, or Stem Cell Transplantation in Treating Young Patients With Kidney Tumors
National Wilms Tumor Study-5 -- Treatment of Relapsed Patients, A National Wilms Tumor Study Group Phase III Study
NCT00002610CI-TRIAL-00015205completedPhase 3ClinicalTrials.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)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. It is not yet known which therapy regimen is most effective for treating patients with kidney tumors. PURPOSE: Phase III trial to compare the effectiveness of chemotherapy with or without radiation therapy, surgery, and/or peripheral stem cell or bone marrow transplantation in treating young patients with kidney tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| conventional surgery | Procedure | — | UNRESOLVED |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| dactinomycin | Biological | Dactinomycin | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- STRATUM A
- description
- Treatment of children in Stratum A will be determined by the site of relapse and the presence of microscopic or gross residual disease after attempted surgical excision of the relapse.
- interventionNames
- Biological: dactinomycin
- Drug: doxorubicin hydrochloride
- Drug: vincristine sulfate
- Procedure: conventional surgery
- Radiation: radiation therapy
- type
- EXPERIMENTAL
- label
- Stratum B
- description
- All children who received combination chemotherapy with Regimen EE - 4A as their initial therapy for Wilms tumor will receive Regimen I and radiation therapy to the site of recurrence. All patients will receive prophylactic trimethoprim /sulfamethoxazole
- interventionNames
- Biological: filgrastim
- Drug: cyclophosphamide
- Drug: doxorubicin hydrochloride
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of Wilms' tumor
* Eligible subtypes:
* Favorable histologies
* Anaplastic histologies
* Clear cell sarcoma of the kidney
* Rhabdoid tumor of the kidney
* Relapsed disease after entry on protocol NWTS-5 (NWTS-Q9401)
PATIENT CHARACTERISTICS:
Age:
* 21 and under at original diagnosis
Performance status:
* Not specified
Life expectancy:
* At least 4 weeks
Hematopoietic:
* Absolute neutrophil count at least 1,000/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.5 times normal
* SGOT or SGPT less than 2.5 times normal
Renal:
* Creatinine no greater than 1.5 times normal OR
* Creatinine clearance or GFR at least 70 mL/min
Cardiovascular:
* Shortening fraction at least 27% by echocardiogram OR
* Ejection fraction greater than 50% by echocardiogram or MUGA scan
Other:
* Not pregnant
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* At least 2 weeks since prior chemotherapy and recovered
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* No prior therapy for relapsed Wilms' tumor
* Recovered from the toxic effects of any other prior therapyReferences
Publications (3)
- BACKGROUNDKalapurakal JA, Perlman EJ, Seibel NL, Ritchey M, Dome JS, Grundy PE. Outcomes of patients with revised stage I clear cell sarcoma of kidney treated in National Wilms Tumor Studies 1-5. Int J Radiat Oncol Biol Phys. 2013 Feb 1;85(2):428-31. doi: 10.1016/j.ijrobp.2012.04.023. Epub 2012 Jun 1. PMID 22658515
- RESULTGreen DM, Cotton CA, Malogolowkin M, Breslow NE, Perlman E, Miser J, Ritchey ML, Thomas PR, Grundy PE, D'Angio GJ, Beckwith JB, Shamberger RC, Haase GM, Donaldson M, Weetman R, Coppes MJ, Shearer P, Coccia P, Kletzel M, Macklis R, Tomlinson G, Huff V, Newbury R, Weeks D. Treatment of Wilms tumor relapsing after initial treatment with vincristine and actinomycin D: a report from the National Wilms Tumor Study Group. Pediatr Blood Cancer. 2007 May;48(5):493-9. doi: 10.1002/pbc.20822. PMID 16547940
- DERIVEDEhrlich PF, Anderson JR, Ritchey ML, Dome JS, Green DM, Grundy PE, Perlman EJ, Kalapurakal JA, Breslow NE, Shamberger RC. Clinicopathologic findings predictive of relapse in children with stage III favorable-histology Wilms tumor. J Clin Oncol. 2013 Mar 20;31(9):1196-201. doi: 10.1200/JCO.2011.41.1165. Epub 2013 Feb 4. PMID 23382471