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

Condition: Renal Tumor, Wilms Tumor

Intervention:

• Other: Proton beam radiation using pencil beam scanning

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

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03810651

Sponsor: Children’s Hospital of Philadelphia

Primary Outcome Measures:

• Measure: 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].
• Time Frame: 90 days
• Safety Issue:

Estimated Enrollment: 25

Study Start Date: December 26, 2017

Phase: Early Phase 1

Eligibility:

• Age: minimum N/A maximum 30 Years
• Gender: All

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

Contact:

• Christine Hill-Kayser, MD
• 215-590-2810

Location:

• Children’s Hospital of Philadelphia
• Philadelphia Pennsylvania 19104 United States

View trial on ClinicalTrials.gov