Recruiting
Early Phase 1

Pencil Beam Scanning

Sponsor:

Children's Hospital of Philadelphia

Code:

NCT03810651

Conditions

Renal Tumor

Wilms Tumor

Eligibility Criteria

Sex: All

Age: 0 - 30

Healthy Volunteers: Not accepted

Interventions

Proton beam radiation using pencil beam scanning

Study Details

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

Study ID

NCT03810651

Start date

Dec 26, 2017

Status verified date

Apr, 2026

Completion date

Oct 30, 2028

Anticipated

Primary completion date

Oct 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 30

Healthy Volunteers: Not accepted

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 Design

Enrollment

28 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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

Primary outcome 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 ]

Central Contacts and Locations

Central contacts

Christine Hill-Kayser, MD

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

Ratnakar Patti

PATTIR@chop.edu

Locations

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Christine Hill-Kayser, MD

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

Ratnakar Patti

PATTIR@chop.edu

More Information

Sponsor

Children's Hospital of Philadelphia

Last update posted

Apr 15, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Children's Hospital of Philadelphia on 2026-04-15.