Pencil Beam Scanning in Patients With Renal Tumors

Wilms Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03810651
• Other study ID #: 17-014386
• Status: Recruiting
• Phase: Early Phase 1
• Start date: December 26, 2017
• Est. completion date: September 30, 2025

Study information

• Verified date: May 2024
• Source: Children's Hospital of Philadelphia
• Contact: Christine Hill-Kayser, MD
• Phone: 215-590-2810
• Email: hill[@]uphs.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: September 30, 2025
• Est. primary completion date: July 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 30 Years

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

Related Conditions & MeSH terms

• Kidney Neoplasms
• Neoplasms
• Renal Tumor
• Wilms Tumor

Intervention

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

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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