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


Description

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

Trial Eligibility

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

Study Info

Organization

Children's Hospital of Philadelphia


Primary Outcome

Occurrence of any non-hematologic toxicity that occurs within 90 days following the start of proton therapy assessed with with NCI Common toxicity criteria (CTC Version 4.0) grades].


Outcome Timeframe 90 days

NCTID NCT03810651

Phases EARLY_PHASE1

Primary Purpose TREATMENT

Start Date 2017-12-26

Completion Date 2025-07-30

Enrollment Target 28

Interventions

OTHER Proton beam radiation using pencil beam scanning

Locations Recruiting

Children's Hospital of Philadelphia

United States, Pennsylvania, Philadelphia


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