Study on Using Risk Factors to Decide Treatment for Children with Favorable Histology Wilms Tumors
Sponsor: Children's Oncology Group
ClinicalTrials ID:NCT06401330
This study is exploring how using specific risk factors can help determine the best treatment for children with a type of kidney cancer called Favorable Histology Wilms Tumor (FHWT). The goal is to improve treatment outcomes and reduce the chance of cancer returning.
Patient Parameters
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Program Overview
This clinical trial is investigating how different risk factors can guide treatment decisions for children with Favorable Histology Wilms Tumor (FHWT), a common kidney cancer in children. By examining tumor characteristics and how they respond to initial treatments, researchers aim to tailor therapies to improve outcomes and reduce the risk of cancer relapse. The study will use information from tumor tests and patient responses to adjust treatment plans, potentially leading to better survival rates for children with FHWT.
Description
The main goal of this study is to find the best treatment approach for children with Favorable Histology Wilms Tumor (FHWT) by considering various risk factors. These factors include the child's age, tumor size, and specific biological features of the tumor. The study will test different combinations of chemotherapy drugs and surgery to see which works best for different groups of patients.
For children with Stage I FHWT, the study will explore whether some can safely receive less treatment after surgery, while others may need additional chemotherapy. For Stage II and III patients, the study will compare different chemotherapy regimens to find the most effective one. Stage IV patients will be evaluated to see if adding more intensive treatments can improve outcomes.
The study will also look at how imaging tests, like CT scans and MRIs, can help detect cancer spread and guide treatment decisions. Researchers will collect blood and urine samples for future research and monitor patients for up to 10 years after treatment to track long-term outcomes.
Overall, the study aims to personalize treatment for children with FHWT, improving their chances of recovery and reducing the risk of cancer returning.
Eligibility Criteria
Inclusion Criteria
- Children under 30 years old with newly diagnosed Stage I-IV Favorable Histology Wilms Tumor.
- Must be enrolled in a related screening study and have a confirmed diagnosis.
- Must have a tumor sample sent for specific genetic testing.
- Must have at least one lymph node sampled during surgery.
- Must meet certain health criteria, including liver and heart function tests.
- Must not have received prior treatment for Wilms Tumor, except in emergencies.
- Must agree to participate and have consent from parents or guardians.
Exclusion Criteria
- Children with Stage V Bilateral Wilms Tumor.
- Children who cannot comply with study procedures.
- Children with uncontrolled illnesses or heart failure.
- Children with certain genetic conditions that increase the risk of Wilms Tumor.
- Children who have had partial kidney removal surgery.
- Children with lung metastases who have had all visible lung nodules removed before certain study points.
- Children who have received prior chemotherapy or radiotherapy for Wilms Tumor.
- Children who have received doxorubicin for another condition.
- Pregnant or breastfeeding females.
- Sexually active participants who do not agree to use contraception.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Alliance for Childhood Diseases/Cure 4 the Kids Foundation | 89135 | Las Vegas | Nevada |
| Albany Medical Center | 12208 | Albany | New York |
| East Carolina University | 27834 | Greenville | North Carolina |
| ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital | 43606 | Toledo | Ohio |
| Prisma Health Richland Hospital | 29203 | Columbia | South Carolina |
| Dell Children's Medical Center of Central Texas | 78723 | Austin | Texas |
| Methodist Children's Hospital of South Texas | 78229 | San Antonio | Texas |
| Children's Hospital of The King's Daughters | 23507 | Norfolk | Virginia |
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