Status:
ACTIVE_NOT_RECRUITING
Combination Chemotherapy With or Without Radiation Therapy in Treating Young Patients With Newly Diagnosed Stage III or Stage IV Wilms' Tumor
Lead Sponsor:
Children's Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Stage III Kidney Wilms Tumor
Stage IV Kidney Wilms Tumor
Eligibility:
All Genders
Up to 29 years
Phase:
PHASE3
Brief 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 use...
Detailed Description
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 pu...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 26 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2026
Estimated Enrollment :
395 Patients enrolled
Trial Details
Trial ID
NCT00379340
Start Date
February 26 2007
End Date
March 31 2026
Last Update
October 27 2025
Active Locations (227)
Enter a location and click search to find clinical trials sorted by distance.
1
Children's Hospital of Alabama
Birmingham, Alabama, United States, 35233
2
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States, 35233
3
USA Health Strada Patient Care Center
Mobile, Alabama, United States, 36604
4
Phoenix Childrens Hospital
Phoenix, Arizona, United States, 85016