Wilms Tumor Treatment with Proton Beam Radiation
This study is for patients with newly diagnosed Wilms tumor, a type of kidney cancer. It's testing a treatment approach that combines standard chemotherapy (DD-4A Chemotherapy Regimen) and surgery (Complete Surgical Resection, Surgical Resection, or Partial Nephrectomy) with a special type of radiation called Proton Beam Radiation (PBRT). Researchers want to see if using PBRT, which aims radiation more precisely, helps children's bodies grow normally on the treated side compared to the untreated side. The study is enrolling up to 260 participants and is open to patients at various stages of their diagnosis or treatment.
- Study design
- This interventional study plans to enroll 260 participants. It is not specified if it is randomized or blinded.
- What's involved
- Participants will receive chemotherapy, surgery, and proton beam radiation therapy based on their cancer stage and surgical findings. The specific schedule and number of visits are not detailed.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 3, 5, and 7 years after finishing proton therapy to measure their body circumference.
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NCT04968990
Treatment of Newly Diagnosed Patient's With Wilm's Tumor Requiring Abdominal Radiation Delivered With Proton Beam Irradiation
Recruiting
PHASE2All AgesInterventionalTreatmentSt. Jude Children's Research HospitalInvestigator-initiated
~260 participants
Updated 2026-04-23 on ClinicalTrials.gov
What's tested:Proton Beam Radiation (PBRT)DD-4A Chemotherapy RegimenComplete Surgical ResectionSurgical ResectionPartial Nephrectomy
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Half circumference at 3 year
Measured over 3 years after all patients finish proton therapy
+3 more outcomes measured
Conditions
Where it's being run
1 sites across 1 statesTennessee1
Study leadership
- Matthew J Krasin, MD · PRINCIPAL_INVESTIGATOR · St. Jude Children's Research Hospital
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Patients are eligible to be enrolled on this trial at the time of initial (or presumptive) diagnosis of Wilms tumor, at the time of surgery or at the time of radiation treatment.
Patients that are determined to be stage I or II will be eligible for the surgical and biologic aspects of this trial but will otherwise be followed per institutional standards and be "off therapy" at the time of stage determination (followed only for survival).
Patients identified to have an anaplastic or other unfavorable tissue component (non-Wilms histology) to their tumor may have tissue assessed for the biology objective but will be removed from the therapeutic portion of the study at the time of identification of this pathologic finding.
Only prior therapy with the initial chemotherapy regimen defined in section 5.1 and Appendix III are allowed for patients that are treated with neoadjuvant chemotherapy. These patients may change to an alternate regime based on response or biologic features and noted in section 5.1. Prior biopsy or surgery is allowed.
Prior radiation therapy is not allowed if directed at the abdomen. Emergent RT to other sites of disease is acceptable.
None - As per institutional standard of care. Diagnosis / Stage
Presumed diagnosis of Wilms tumor (continued management on trial will depend on stage and histology)
Resected upfront stage III, IV or V favorable histology Wilms tumor. Stage III includes any one or multiples of the following:
Lymph nodes within the abdomen or pelvis are involved by tumor. (Lymph node involvement in the thorax, or other extra-abdominal sites is a criterion for Stage IV)
The tumor has penetrated through the peritoneal surface
Tumor implants are found on the peritoneal surface
Gross or microscopic tumor remains post-operatively (e.g., tumor cells are found at the margin of surgical resection on microscopic examination - in the post chemotherapy setting only specific types of viable tumor at the surgical margin are considered stage III AND require adjuvant radiation - see surgery / pathology / radiation section for additional details)
The tumor is not completely resectable because of local infiltration into vital structures
Tumor spillage occurring either before or during surgery
A trans abdominal biopsy (regardless of type- tru-cut, open or fine needle aspiration) was performed prior to resection or chemotherapy. Retroperitoneal biopsies DO NOT require radiotherapeutic management like stage III
Tumor is removed in greater than one piece (e.g. tumor cells are found in a separately excised adrenal gland; a tumor thrombus within the renal vein is removed separately from the nephrectomy specimen). Extension of the primary tumor within vena cava into thoracic vena cava and heart is considered Stage III, rather than Stage IV even though outside the abdomen.
Stage IV - Hematogenous metastases (lung, liver, bone, brain, etc.), or lymph node metastases outside the abdomino-pelvic region are present. (The presence of tumor within the adrenal gland is not interpreted as metastasis and staging depends on all other staging parameters present). Patients with lung involvement and local abdominal stage I or II are eligible to remain on trial for whole lung irradiation objective.
Stage V - Bilateral renal involvement by tumor is present at diagnosis. An attempt should be made to stage each side according to the above criteria on the basis of the extent of disease
Patients that have or will receive neoadjuvant chemotherapy for unresected unilateral or bilateral Wilms tumor without a biopsy are not assumed to be require adjuvant radiation on this study. That determination will be based on surgical findings and the approach to treatment detailed in the protocol.
Patients undergoing upfront surgery must start RT, if indicated, within 28 days of definitive surgery with a goal of starting RT by day 21.
Patients receiving neoadjuvant chemotherapy will be enrolled either at diagnosis (if at St. Jude) or at the time of RT.
Exclusion
Inability or unwillingness to provide written informed consent
Prior radiation therapy to a site to be treated with proton / photon radiation as part of this trial. Emergent radiation is allowed.
What this trial measures
- Half circumference at 3 year3 years after all patients finish proton therapy
Half circumference measurement at 3 year from irradiated and unirradiated hemi-abdomen for patients in need of flank radiation
- Half circumference at 5 year5 years after all patients finish proton therapy
Half circumference measurement at 5 year from irradiated and unirradiated hemi-abdomen for patients in need of flank radiation
- Half circumference at 7 year7 years after all patients finish proton therapy
Half circumference measurement at 7 year from irradiated and unirradiated hemi-abdomen for patients in need of flank radiation
- Half circumference at 10 yearHalf circumference measurement at 10 year from irradiated and unirradiated hemi-abdomen
Half circumference measurement at 10 year from irradiated and unirradiated hemi-abdomen for patients in need of flank radiation