Proton Beam Radiation for Wilms Tumor
Trial Summary
What is the purpose of this trial?
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.
Do I need to stop my current medications for the trial?
The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss your specific medications with the trial team to get a clear answer.
What data supports the effectiveness of the treatment Proton Beam Radiation for Wilms Tumor?
Proton beam therapy (PBT) is considered a promising treatment for childhood cancers, including Wilms tumor, because it can target tumors more precisely and reduce radiation exposure to healthy tissues, potentially leading to fewer side effects. Studies suggest that PBT may be particularly beneficial for tumors in complex areas or those surrounded by sensitive tissues, which is often the case in pediatric cancers.12345
Is proton beam therapy generally safe for humans?
How is Proton Beam Radiation different from other treatments for Wilms Tumor?
Proton Beam Radiation (PBT) is unique because it precisely targets tumors with minimal damage to surrounding healthy tissues, making it especially beneficial for treating childhood cancers like Wilms Tumor. This precision is due to the Bragg peak effect, where protons release most of their energy directly at the tumor site, reducing side effects compared to traditional radiation therapies.3491011
Research Team
Matthew J Krasin, MD
Principal Investigator
St. Jude Children's Research Hospital
Eligibility Criteria
This trial is for patients with a newly diagnosed Wilms Tumor, who haven't had abdominal radiation before. It's open to those who've only had specific initial chemotherapy or surgery, and are within certain time frames post-surgery. Pregnant women can't participate, nor can those unwilling to consent or previously treated with radiation in the areas targeted by this study.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Induction Chemotherapy
Participants undergo 6-12 weeks of induction chemotherapy before surgical resection
Surgical Resection
Participants undergo surgical resection at diagnosis or after induction chemotherapy
Adjuvant Radiation Therapy
Participants receive adjuvant proton beam radiation therapy based on stage and surgical findings
Systemic Therapy
Systemic therapy delivered in a standard of care manner according to histology and stage
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Proton Beam Radiation (PBRT) (Proton Beam Therapy)
Proton Beam Radiation (PBRT) is already approved in Canada for the following indications:
- Wilms tumor
- Brain tumors
- Breast cancer
- Esophageal cancer
- Eye cancer
- Gynecological cancers
- Head and neck cancer
- Liver cancer
- Lung cancer
- Lymphoma
- Pancreatic cancer
- Prostate cancer
- Rectal cancer
- Sarcomas
- Spinal cord tumors
Find a Clinic Near You
Who Is Running the Clinical Trial?
St. Jude Children's Research Hospital
Lead Sponsor