This pilot trial studies how well pencil beam scanning proton therapy works in treating patients with kidney tumors. Usual treatment for patients with kidney tumors is radiation using x-rays. X-ray radiation kills tumor cells, but can also cause harm to normal parts of the body such as the bowel and liver. Pencil beam scanning proton beam radiation also kills tumor cells, but can be stopped after the treatment is given to the area where the tumor cells are or were. This results in less radiation to normal parts of the body. This study tests whether pencil beam scanning proton beam radiation works as well as x-ray radiation therapy.
Additional locations may be listed on ClinicalTrials.gov for NCT03810651.
Locations matching your search criteria
United States
Pennsylvania
Philadelphia
Children's Hospital of PhiladelphiaStatus: Active
Contact: Christine E. Hill-Kayser
Phone: 215-662-7771
PRIMARY OBJECTIVES:
I. To demonstrate the feasibility of pencil beam scanning proton therapy for treatment of renal tumors based on:
Ia. Occurrence of any grade non-hematologic toxicity within three months after the completion of radiation treatment.
Ib. Evaluate renal and hepatic function during and after pencil beam scanning proton therapy (PBS-PT) using laboratory based markers (LFTs).
SECONDARY OBJECTIVES:
I. To evaluate efficacy of PBS-PT for patients with renal tumors as determined by time to local failure, time to distant failure, relapse-free survival, cause-specific survival, overall survival, according to patient clinical stage and radiotherapy target volume treated.
II. To pilot a renal tumor specific patient-reported outcome survey assessing the incidence and severity of disease-related and treatment-related symptoms, monitor patient nutritional status as measured by weight and use of a gastrostomy (G)-tube, and evaluate need for anti-emetic medications.
III. To perform a prospective dosimetric comparison study between PBS-PT and anterior-posterior-posterior-anterior (AP-PA) photon flank fields.
IV. To determine the incidence of additional acute toxicities of proton radiotherapy in patients with stage I-IV renal tumors including abdominal pain, nausea, diarrhea, fatigue, weight loss, and anorexia.
V. To evaluate patients who may be at increased risk of local or regional recurrence based on histologic findings (favorable histology, focal anaplasia, diffuse anaplasia, clear cell sarcoma histology) and genetic markers (loss of heterozygosity [LOH] 1p and 16q).
VI. To assess late complications from radiation including gastrointestinal perforation, obstruction, stricture, or bleeding; secondary malignancy; kidney failure or hypertension; liver failure or venooclusive disease; diabetes; musculoskeletal and growth disorders; and infertility.
OUTLINE:
Patients with stage I-IV completely resected tumors undergo PBS-PT once daily for five fractions per week. Patients with stage I-IV incompletely resected tumors undergo PBS-PT may undergo an additional 5 fraction boost as standard of care. Patients with stage IV disease requiring pulmonary irradiation also undergo 7-8 fractions of whole lung irradiation concurrently with flank irradiation.
After completion of study treatment, patients are followed up at 90 days after start of radiation therapy, then every 3-5 months for years 1-2, and then every 6-8 months for years 3-5.
Lead OrganizationChildren's Hospital of Philadelphia
Principal InvestigatorChristine E. Hill-Kayser
