Pencil Beam Scanning in Patients With Renal Tumors

NCT ID: NCT03810651

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-26
• Study Completion Date: 2027-10-30

Brief Summary

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

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

Conditions

Renal Tumor; Wilms Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Proton beam radiation using pencil beam scanning

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital of Philadelphia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christine Hill-Kayser, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Christine Hill-Kayser, MD

Role: CONTACT

hill@uphs.upenn.edu

215-590-2810

Ratnakar Patti

Role: CONTACT

PATTIR@chop.edu

Facility Contacts

Christine Hill-Kayser, MD

Role: primary

hill@uphs.upenn.edu

215-590-2810

Ratnakar Patti

Role: backup

PATTIR@chop.edu

Other Identifiers

17-014386

Identifier Type: -

Identifier Source: org_study_id