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Treatment of Newly Diagnosed Patient's With Wilm's Tumor Requiring Abdominal Radiation Delivered With Proton Beam Irradiation

StatusRecruiting
PhasePhase 2
Started2021-08-19
View on ClinicalTrials.gov ↗

Amendment history

2026-04-22
minor
Study Status, Contacts/Locations v11
Study sitescontacts updated at 1 of 1 site
2026-01-21
minor
Study Status, Study Design v10
Enrollment target95→260
2025-12-03
minor
6 amendments v4-v9
6 re-verifications since 2022-09-01, no change to tracked fields
2021-09-01
minor
Study Status v3
Start dateestimated 2021-08→confirmed 2021-08-19
2021-08-13
notable
Not Yet Recruiting→Recruiting Study Status, Study Design, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Study sitesdetails revised at 1 of 1 site
2021-08-02
minor
Study Status, Study Design, Eligibility v1
Start date2021-07→2021-08
2021-07-09
minor
Original filing
Participants are being asked to take part in this clinical trial, a type of research study, because the participants have a Wilms Tumor cancer. Primary Objectives To determine whether delivery of proton beam radiation to a conformal reduced target volume in the flank allows normal flank growth compared to the contralateral untreated side and non-irradiated patients. Secondary Objectives To deliver proton beam radiation to a conformal reduced target volume (partial kidney proton beam radiation therapy) in the affected kidney(s) for patients with Stage V (bilateral Wilms tumor) and specific involved surgical margins yielding no reduction in the high control rates seen with more traditional flank / whole kidney fields. Exploratory Objectives * Study the feasibility of sparing the residual kidney, spine and liver in patients requiring whole abdomen radiation therapy using either a proton beam treatment technique or intensity-modulated radiation therapy ( IMRT) photon based technique. * Study the feasibility of delivering whole lung radiation therapy with proton beams with the goals of sparing the developing breast tissue, heart structures, thyroid and liver. * Develop simultaneous xenografts and organoid models from the same starting material to study Wilms tumor biology and compare responses to chemotherapeutic agents. * Define the evolution of organ specific (kidney, liver, pancreas, etc.) abnormalities (laboratory studies) as an early marker of possible late end organ damage and their relationship to radiation. * Study and evaluate impact of proton therapy on the musculoskeletal system and physical performance and compare with photon therapy cases treated with classical treatment fields. * Assess CTC-AE and Pediatric Patient Reported Outcomes during radiation and in follow-up, correlating with disease, treatment and patient variables. * Correlate quantitative MRI values, including apparent diffusion coefficient (ADC) values, with histopathology findings post-surgery in children with (bilateral) Wilms. * Assess daily variations in proton range along each treatment beam using standard pre-treatment cone beam CT or on-treatment MR.
Trial Details
NCT Number NCT04968990
Lead Sponsor St. Jude Children's Research Hospital
Conditions Wilms Tumor
Enrollment 260 participants
Start Date 2021-08-19
Primary Completion 2026-12 (estimated)
Study Completion 2036-12 (estimated)
Updated on ClinicalTrials.gov 2026-04-23