NCT03810651

Pencil Beam Scanning in Patients With Renal Tumors

Pilot Study of Pencil Beam Scanning Proton Beam Radiation Therapy in Patients With Renal Tumors

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Children's Hospital of Philadelphia · Academic / Other
• Sex: All
• Age: 0 Years – 30 Years
• Healthy volunteers: Not accepted

Summary

This is a pilot study to assess acute toxicity in patients receiving flank irradiation using proton therapy for renal tumors.

Detailed description

Patients with renal tumors including Wilms and clear cell sarcoma of the kidney (CCSK) are treated with multimodality therapy which may include surgery, chemotherapy, and radiation. While long-term disease control is excellent, these patients remain at risk for early and late toxicities partially from radiation. There have been no significant changes to traditional photon radiation fields, which encompass the post-operative bed, anterior abdomen, and vertebral body. Proton beam radiation using pencil beam scanning, which is characterized by Bragg peak dose deposition and high conformality of dose to target regions, is ideally suited to treat the retroperitoneum. This pilot study evaluates pencil beam scanning proton therapy (PBS-PT) to: * result in low acute gastrointestinal toxicity in patients receiving radiation therapy for renal tumors as measured by laboratory evaluations, clinician-assessed, and patient reported health related quality of life outcomes * decrease the duration of radiation therapy * compare doses to organs at risk (OARs) using PBS-PT as compared to traditional photon fields

Conditions

• Renal Tumor
• Wilms Tumor

Interventions

Type	Name	Description
OTHER	Proton beam radiation using pencil beam scanning	Proton beam radiation using pencil beam scanning, characterized by Bragg peak dose deposition and high conformality of dose to target regions

Timeline

• Start date: 2017-12-26
• Primary completion: 2027-10-30
• Completion: 2028-10-30
• First posted: 2019-01-22
• Last updated: 2026-04-15

Locations

1 site across 1 country: United States