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SJWT21: Study of Proton Therapy in Patients with Wilms Tumor following Nephrectomy

Multi-Center Trial for the Treatment of Patients with Stage III-V Wilms Tumor Requiring Abdominal Radiation Delivered with Proton Beam Irradiation following Nephrectomy or Partial Nephrectomy

Categories:

Radiology

Solid Tumor

Surgery

Diseases Treated:

Wilms Tumor

Eligibility Overview:

  • Diagnosis of Wilms tumor
  1. Brief Summary

    This is a phase 2 clinical trial to evaluate the effects of proton beam therapy in treating patients with stage III-V Wilms tumor who require abdominal irradiation following nephrectomy or partial nephrectomy.

    Patients with Wilms tumor have a high survivorship, thanks to current treatment strategies that may include chemotherapy, surgery and radiation therapy. However, one-third of those who require radiation treatment experience related late effects, including reduced growth and development, secondary malignancies and multiple organ toxicities.

    Proton therapy is an alternative to standard photon radiation techniques and offers a reduced risk of complications. The proton beam’s energy can be modulated so protons do not exit the tumor and go into healthy tissues behind, thus minimizing the risk of injury to surrounding tissues. In this study, we will modify the indications for proton radiation as well as targeting and delivery to reduce complications compared to conventional photon-based approaches.

    Primary Objective

    • To determine whether 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

    Eligibility Criteria

    Inclusion criteria include:

    • Diagnosis of non-recurrent favorable histology Wilms tumor
    • Karnofsky performance status ≥ 50 for patients older than 16 years
    • Lansky performance status ≥ 50 for patients 16 years old and younger
    • Not pregnant

    Exclusion Criteria include:

    • Prior radiation to a site to be treated with proton/photon radiation as part of this trial. Emergent radiation is allowed.

    Study Sites

    St. Jude Children’s Research Hospital
    Memphis, Tennessee

    Collaborating sites in the U.S.

  2. About this study

    This is a study to find out how well proton therapy treats Wilms tumor without damaging nearby healthy tissues.

    The standard treatment for Wilms tumor is surgery  plus chemotherapy, followed by radiation, in some cases. The type of radiation patients generally receive is called photon radiation. This procedure uses high-energy x-rays that pass through the tumor and come out the other side. 

    This study uses a different type of radiation, called proton radiation. It uses particles instead of x-rays. These particles deliver most of their radiation inside the tumor. This method reduces the chance of damaging surrounding tissue. 

    If you participate in this study, you will receive chemotherapy drugs and surgery, if needed, followed by proton therapy. Your response to this treatment will be compared to that of patients who had photon radiation in the past.

    Purpose of this clinical trial

    The main goal of this study is to find out if proton therapy causes fewer long-term side effects in patients with Wilms tumor than standard radiation treatment.

    Eligibility overview

    • Diagnosis of Wilms tumor
  3. SJWT21
    Sponsors: St. Jude Children’s Research Hospital
    ClinicalTrials.gov identifier NCT04968990
    Trial Start Date: August 2021
    Estimated Enrollment: 95
    Study Type: Interventional
    Study Phase: Phase 2  
    Conditions: Wilms tumor
    Ages: Any
    Principal investigator: Matthew Krasin, MD
    Andrew Davidoff, MD
    Study Sites: St. Jude Children’s Research Hospital and collaborating sites outside the U.S.
    For a consultation or to discuss SJWT21: St. Jude Physician/Patient Referral Office
    1-888-226-4343
    referralinfo@stjude.org

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334
Email: referralinfo@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.