Pencil Beam Scanning in Patients With Renal Tumors

NCT03810651 | Recruiting Early Phase 1

• 1 other identifier: 17-014386
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Renal Tumor; Wilms Tumor

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Renal tumors

OTHER

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

Interventions

Proton beam radiation using pencil beam scanning OTHER

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

Renal tumors

Eligibility Criteria

• Age: 0 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• Any patient with favorable histology (FH), stage III disease
• Any patient with focal or diffuse anaplasia
• 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

You may not qualify if:

• Prior radiotherapy to the region of the study cancer
• Chemotherapy administered for diagnosis of Wilms tumor or CCSK
• Pregnant or breastfeeding

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Renal Cell; Wilms Tumor

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Neoplasms, Complex and Mixed; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Christine Hill-Kayser, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine Hill-Kayser, MD

CONTACT

215-590-2810; hill@uphs.upenn.edu

Ratnakar Patti

CONTACT

PATTIR@chop.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2019
• First Posted: January 22, 2019
• Study Start: December 26, 2017
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): October 30, 2028
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)