Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Location status: Recruiting
Location contact
Christine Hill-Kayser, MD
CONTACT
Ratnakar Patti
CONTACT
NCT Number: NCT03810651
This is a pilot study to assess acute toxicity in patients receiving flank irradiation using proton therapy for renal tumors.
Interested in participating?
Request Info0 year–30 year
All sexes
Interventional
Early Phase 1
Philadelphia, Pennsylvania, 19104, United States
Location status: Recruiting
Christine Hill-Kayser, MD
CONTACT
Ratnakar Patti
CONTACT
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
a. Any patient with Wilms tumor or clear cell sarcoma of the kidney who would require radiation therapy as standard of care including
Exclusion criteria
Proton beam radiation using pencil beam scanning, characterized by Bragg peak dose deposition and high conformality of dose to target regions
Time frame: 90 days
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.
Contact information is provided by the study sponsor or research team.
Christine Hill-Kayser, MD
CONTACT
Ratnakar Patti
CONTACT
Children's Hospital of Philadelphia
Other
Pilot Study of Pencil Beam Scanning Proton Beam Radiation Therapy in Patients With Renal Tumors
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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