Pencil Beam Scanning in Patients With Renal Tumors
Primary Purpose
Renal Tumor, Wilms Tumor
Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Proton beam radiation using pencil beam scanning
Sponsored by
About this trial
This is an interventional treatment trial for Renal Tumor
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
- 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
Exclusion Criteria:
- Prior radiotherapy to the region of the study cancer
- Chemotherapy administered for diagnosis of Wilms tumor or CCSK
- Pregnant or breastfeeding
Sites / Locations
- Children's Hospital of PhiladelphiaRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Renal tumors
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03810651
First Posted
January 15, 2019
Last Updated
June 21, 2023
Sponsor
Children's Hospital of Philadelphia
1. Study Identification
Unique Protocol Identification Number
NCT03810651
Brief Title
Pencil Beam Scanning in Patients With Renal Tumors
Official Title
Pilot Study of Pencil Beam Scanning Proton Beam Radiation Therapy in Patients With Renal Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 26, 2017 (Actual)
Primary Completion Date
July 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Tumor, Wilms Tumor
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Renal tumors
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Proton beam radiation using pencil beam scanning
Intervention Description
Proton beam radiation using pencil beam scanning, characterized by Bragg peak dose deposition and high conformality of dose to target regions
Primary Outcome Measure Information:
Title
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].
Description
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.
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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
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
Exclusion Criteria:
Prior radiotherapy to the region of the study cancer
Chemotherapy administered for diagnosis of Wilms tumor or CCSK
Pregnant or breastfeeding
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christine Hill-Kayser, MD
Phone
215-590-2810
Email
hill@uphs.upenn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ratnakar Patti
Email
PATTIR@chop.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine Hill-Kayser, MD
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Hill-Kayser, MD
Phone
215-590-2810
Email
hill@uphs.upenn.edu
First Name & Middle Initial & Last Name & Degree
Ratnakar Patti
Email
PATTIR@chop.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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Pencil Beam Scanning in Patients With Renal Tumors
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