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

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.

Conditions

• Wilms Tumor

Interventions

DEVICE

Proton 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.

DRUG

DD-4A Chemotherapy Regimen

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

PROCEDURE

Complete Surgical Resection

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

PROCEDURE

Surgical Resection

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

PROCEDURE

Partial Nephrectomy

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

Sponsors & Collaborators

• St. Jude Children's Research Hospital

  lead OTHER

Principal Investigators

• Matthew J Krasin, MD · St. Jude Children's Research Hospital

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-08-19

Primary Completion

2026-12-31

Completion

2036-12-31

FDA Device

Yes

Countries

• United States

Study Locations