RecruitingPhase 2NCT04968990

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

Multi-Center Trial Sponsored by St. Jude Children's Research Hospital for the Treatment of Newly Diagnosed Patient's With Wilm's Tumor Requiring Abdominal Radiation Delivered With Proton Beam Irradiation


Sponsor

St. Jude Children's Research Hospital

Enrollment

260 participants

Start Date

Aug 19, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Plain Language Summary

Simplified for easier understanding

This study is testing whether proton beam radiation (a more targeted form of radiation that reduces damage to nearby healthy tissue) is effective and safe for children with Wilms' tumour (a kidney cancer that mainly affects young children) who need abdominal radiation after surgery. **You may be eligible if...** - You have been newly diagnosed with Wilms' tumour (the most common kidney cancer in children) - You are enrolled at the time of initial diagnosis, surgery, or when radiation is being planned - Your cancer requires abdominal radiation as part of treatment - Your performance level is adequate for participation **You may NOT be eligible if...** - Your tumour has a highly unfavourable tissue type (anaplastic or non-Wilms histology) — these patients may still contribute tissue samples but will not receive the study's main treatment - Your performance status is too low - Stage I or II patients are enrolled for follow-up but do not receive radiation through this trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEProton Beam Radiation (PBRT)

The 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.

DRUGDD-4A Chemotherapy Regimen

Patients will receive standard of care chemotherapy based on diagnosis and stage.

PROCEDUREComplete Surgical Resection

Participants will undergo complete surgical resection at diagnosis or after 6-12 weeks of induction chemotherapy

PROCEDURESurgical Resection

Participants will undergo surgical resection at diagnosis or after 6-12 weeks of induction chemotherapy.

PROCEDUREPartial Nephrectomy

Participants will undergo partial nephrectomy after 6-12 weeks of induction chemotherapy.


Locations(1)

St.Jude Children's Research Hospital

Memphis, Tennessee, United States

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NCT04968990


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