OncoMatch/Clinical Trials/NCT04968990
Treatment of Newly Diagnosed Patient's With Wilm's Tumor Requiring Abdominal Radiation Delivered With Proton Beam Irradiation
Is NCT04968990 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Proton Beam Radiation (PBRT) and DD-4A Chemotherapy Regimen for wilms tumor.
Treatment: Proton Beam Radiation (PBRT) · DD-4A Chemotherapy Regimen — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Disease stage
Required: Stage I, II, III, IV, V
Patients that are determined to be stage I or II will be eligible for the surgical and biologic aspects of this trial... Resected upfront stage III, IV or V favorable histology Wilms tumor. Stage III includes any one or multiples of the following: ... Stage IV - Hematogenous metastases (lung, liver, bone, brain, etc.), or lymph node metastases outside the abdomino-pelvic region are present. ... Stage V - Bilateral renal involvement by tumor is present at diagnosis.
Prior therapy
Cannot have received: radiation therapy
Exception: emergent rt to other sites of disease is acceptable
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- St.Jude Children's Research Hospital · Memphis, Tennessee
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT04968990 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior radiation therapy disqualifies patients from enrollment.
What disease stage is eligible?
Stage I or II or III or IV or V is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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