Clinical trial · Interventional
Pencil Beam Scanning in Patients With Renal Tumors
Pilot Study of Pencil Beam Scanning Proton Beam Radiation Therapy in Patients With Renal Tumors
NCT03810651CI-TRIAL-00108247recruitingEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a pilot study to assess acute toxicity in patients receiving flank irradiation using proton therapy for renal tumors.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Renal Tumor | Kidney Neoplasm | ALIAS | 0.90 |
| Wilms Tumor | Wilms Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Proton beam radiation using pencil beam scanning | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Renal tumors
- 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.
- interventionNames
- Other: Proton beam radiation using pencil beam scanning
Primary outcomes (1)
- 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].
- timeFrame
- 90 days
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 0 Years
- Maximum age
- 30 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.