Study on Proton Beam Radiation for Newly Diagnosed Wilms Tumor Patients Needing Abdominal Radiation

Sponsor: St. Jude Children's Research Hospital

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04968990

Provider View

This clinical trial is exploring the use of proton beam radiation therapy for children with Wilms Tumor, a type of kidney cancer, to see if it can help control the cancer while allowing normal growth of the body.

Patient Parameters

Program Overview

This study is for children with Wilms Tumor, a type of kidney cancer. It aims to find out if using proton beam radiation, which is a precise form of radiation therapy, can help control the cancer while allowing normal growth of the body. The study will also look at whether this treatment can be safely used on the affected kidney and other organs, and how it compares to traditional radiation methods. Researchers will also study the effects of this treatment on the body and how it impacts physical performance.

Description

Participants in this study will receive proton beam radiation therapy (PBRT) based on their cancer stage and surgical findings.

  • For patients with early-stage cancer (Stage I & II) and clear surgical margins, PBRT will not be given if there is no evidence of cancer spread or remaining cancer cells. Standard chemotherapy will be provided based on the cancer type and stage.

  • For patients with more advanced cancer (Stage III & IV), PBRT will be given if there is evidence of cancer spread to lymph nodes, surgical margins, or other areas. Standard chemotherapy will also be provided.

  • For patients with cancer in both kidneys (Stage V), PBRT will be given after partial kidney removal if there is evidence of cancer spread. Standard chemotherapy will be provided.

The study follows standard treatment guidelines to ensure consistent care, while focusing on the specific trial objectives.

Eligibility Criteria

Inclusion Criteria

  • Children diagnosed with Wilms Tumor at any stage of treatment, including at diagnosis, surgery, or radiation.
  • Children with Stage I or II cancer will be part of the surgical and biological aspects of the study but will follow standard care for survival.
  • Children with certain unfavorable tumor types will be assessed for biological study but not for treatment.
  • Must have a performance status score of 50 or higher, indicating the ability to carry out daily activities.
  • Only initial chemotherapy as specified in the study is allowed before joining the trial.
  • No prior radiation therapy to the abdomen.
  • Must have a presumed diagnosis of Wilms Tumor, with continued management based on stage and tumor type.
  • Must start radiation therapy within 28 days of surgery if needed.
  • Female participants aged 10 or older must have a negative pregnancy test before joining the study.

Exclusion Criteria

  • Unable or unwilling to provide written consent.
  • Prior radiation therapy to the area being treated in this study, except for emergency situations.

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