Actively Recruiting

Phase 2
All Genders
NCT04968990

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

Led by St. Jude Children's Research Hospital · Updated on 2026-04-23

260

Participants Needed

1

Research Sites

797 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with a diagnosis or presumed diagnosis of Wilms tumor at initial diagnosis, surgery, or radiation treatment
  • Stage I or II patients eligible for surgical and biologic study aspects and followed per institutional standards
  • Patients without anaplastic or unfavorable tumor tissue remain in therapeutic study
  • Karnofsky performance status of 50 or higher for patients over 16 years
  • Lansky performance status of 50 or higher for patients 16 years or younger
  • Prior therapy limited to initial chemotherapy regimen defined in protocol; prior biopsy or surgery allowed
  • No prior abdominal radiation therapy
  • Presumed diagnosis of Wilms tumor with stage III, IV, or V favorable histology and specific surgical/pathologic features for radiation therapy
  • Patients with stage IV metastases limited to defined sites; stage V with bilateral renal involvement
  • Radiation therapy to start within 28 days after surgery when indicated
  • Female patients of childbearing potential must have a negative pregnancy test prior to enrollment
Not Eligible

You will not qualify if you...

  • Inability or unwillingness to provide informed consent
  • Prior radiation therapy directed at the abdomen or treatment sites planned for this trial (except emergent radiation to other disease sites)

AI-Screening

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Trial Site Locations

Total: 1 location

1

St.Jude Children's Research Hospital

Memphis, Tennessee, United States, 38105

Actively Recruiting

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Research Team

M

Matthew J Krasin, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

3

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