Pencil Beam Scanning in Patients With Renal Tumors
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age0-30
SponsorChildren's Hospital of Philadelphia
About this trial
This is a pilot study to assess acute toxicity in patients receiving flank irradiation using proton therapy for renal tumors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Less than 30 years of age
Diagnosis
Any patient with favorable histology (FH), stage III disease
Any patient with focal or diffuse anaplasia
Disqualifiers
Prior radiotherapy to the region of the study cancer
Chemotherapy administered for diagnosis of Wilms tumor or CCSK
Pregnant or breastfeeding
Trial design
Design model
Single group
Treatments tested in this trial
Proton beam radiation using pencil beam scanning
Other interventionProton beam radiation using pencil beam scanning, characterized by Bragg peak dose deposition and high conformality of dose to target regions
Treatment groups
28 Participants
are divided into 1 treatment groupGroup A: Renal tumorsOther 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
90 daysSponsors and contacts
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Source ClinicalTrials.gov