Proton therapy for children with renal tumors
Pilot Study of Pencil Beam Scanning Proton Beam Radiation Therapy in Patients With Renal Tumors
This study is testing a new type of proton therapy for children with kidney tumors to see if it can reduce side effects from treatment while still being effective.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 0 Years to 30 Years |
| Sex | All |
| Sponsor | Children's Hospital of Philadelphia Academic / other |
| Drugs / interventions | Chemotherapy, radiation |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT03810651 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the use of pencil beam scanning proton therapy in patients with renal tumors, including Wilms tumor and clear cell sarcoma of the kidney. The approach aims to minimize acute gastrointestinal toxicity associated with radiation therapy while maintaining effective treatment. Patients will undergo assessments of health-related quality of life and laboratory evaluations to measure toxicity levels. The study also compares the radiation doses to organs at risk using this advanced proton therapy technique versus traditional photon radiation.
Who should consider this trial
Good fit: Ideal candidates are patients under 30 years old diagnosed with Wilms tumor or clear cell sarcoma of the kidney requiring radiation therapy.
Not a fit: Patients who have previously received radiation therapy to the affected area or are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce radiation-related side effects in young patients with renal tumors.
How similar studies have performed: Other studies have shown promise with proton therapy in reducing toxicity, but this specific approach using pencil beam scanning is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Less than 30 years of age * Diagnosis a. Any patient with Wilms tumor or clear cell sarcoma of the kidney who would require radiation therapy as standard of care including 1. Any patient with favorable histology (FH), stage III disease 2. Any patient with focal or diffuse anaplasia 3. Any patient with CCSK * The patient is a candidate for external beam radiotherapy based on standard of care for treatment of Wilms tumor or CCSK Exclusion Criteria: * Prior radiotherapy to the region of the study cancer * Chemotherapy administered for diagnosis of Wilms tumor or CCSK * Pregnant or breastfeeding
Where this trial is running
Philadelphia, Pennsylvania
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Christine Hill-Kayser, MD — Children's Hospital of Philadelphia
- Study coordinator: Christine Hill-Kayser, MD
- Email: hill@uphs.upenn.edu
- Phone: 215-590-2810
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.