Pencil Beam Scanning in Patients With Renal Tumors

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

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

Study Overview

• Status: Recruiting
• Conditions: Renal Tumor; Wilms Tumor
• Intervention / Treatment: Other: Proton beam radiation using pencil beam scanning

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

• Study Type: Interventional
• Enrollment (Estimated): 28
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Christine Hill-Kayser, MD; Phone Number: 215-590-2810; Email: hill@uphs.upenn.edu
• Study Contact Backup: Name: Ratnakar Patti; Email: pattir@chop.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Children's Hospital of Philadelphia
      • Contact: Christine Hill-Kayser, MD; Phone Number: 215-590-2810; Email: hill@uphs.upenn.edu
      • Contact: Ratnakar Patti; Email: pattir@chop.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 26 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Renal tumors; Any patient with Wilms tumor or clear cell sarcoma of the kidney who would require radiation therapy as standard of care. Patients may receive an investigation drug for Wilms or CCSK given concurrently or within the first four weeks of the first fraction of proton therapy administration.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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].	Acute toxicity in patients receiving flank irradiation using proton therapy for renal tumors. Acute toxicity is defined as any non-hematologic toxicity that occurs within 90 days following the start of proton therapy. NCI Common toxicity criteria (CTC Version 4.0) grades will be employed. Individual category content listings are available to investigators at http://ctep.cancer.gov, with attention to the following System Organ Classes and CTCAE Adverse Events: General Disorders and Administration Site Conditions, Hepatobiliary Disorders, Blood and Lymphatic System Disorders, Gastrointestinal Disorders, Renal and Urinary Disorders, Injury, poisoning, or procedural complications, Metabolism and nutrition disorders, and Benign, Malignant, and Unspecified Neoplasms.	90 days

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia
• Investigators: Principal Investigator: Christine Hill-Kayser, MD, Children's Hospital of Philadelphia

Study record dates

Study Major Dates

• Study Start (Actual): December 26, 2017
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): October 30, 2028

Study Registration Dates

• First Submitted: January 15, 2019
• First Submitted That Met QC Criteria: January 17, 2019
• First Posted (Actual): January 22, 2019

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genetic Diseases, Inborn; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Urologic Neoplasms; Carcinoma; Kidney Neoplasms; Neoplastic Syndromes, Hereditary; Neoplasms, Complex and Mixed; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Carcinoma, Renal Cell; Wilms Tumor
• Other Study ID Numbers: 17-014386

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No