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.
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.
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.
Single group
Proton Beam Radiation (PBRT)
DeviceThe treatment approach with radiation therapy prescribed in this trial is designed to deliver highly conformal radiation therapy (proton beam radiation or intensity modulated photon radiation) to target volumes that are based on the burden of disease.
DD-4A Chemotherapy Regimen
DrugPatients will receive standard of care chemotherapy based on diagnosis and stage.
Complete Surgical Resection
Procedure/SurgeryParticipants will undergo complete surgical resection at diagnosis or after 6-12 weeks of induction chemotherapy
Surgical Resection
Procedure/SurgeryParticipants will undergo surgical resection at diagnosis or after 6-12 weeks of induction chemotherapy.
Partial Nephrectomy
Procedure/SurgeryParticipants will undergo partial nephrectomy after 6-12 weeks of induction chemotherapy.
Half circumference at 3 year
Half circumference measurement at 3 year from irradiated and unirradiated hemi-abdomen for patients in need of flank radiation
Half circumference at 5 year
Half circumference measurement at 5 year from irradiated and unirradiated hemi-abdomen for patients in need of flank radiation
Half circumference at 7 year
Half circumference measurement at 7 year from irradiated and unirradiated hemi-abdomen for patients in need of flank radiation
Half circumference at 10 year
Half circumference measurement at 10 year from irradiated and unirradiated hemi-abdomen for patients in need of flank radiation
Local control rate in a partially radiated kidney
This objective is to investigate whether deliver proton beam radiation to a conformal reduced target volume (partial kidney proton beam radiation therapy) in the affected kidney(s) for patients Stage V (bilateral Wilms tumor) with specific involved surgical margins yielding no reduction in the high control rates seen with more traditional flank / whole kidney fields.
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