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Proton Beam Therapy

Proton Therapy for Kidney Cancer

Phase < 1
Recruiting
Led By Christine Hill-Kayser, MD
Research Sponsored by Children's Hospital of Philadelphia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of Wilms tumor or clear cell sarcoma of the kidney requiring radiation therapy as standard of care, including favorable histology (FH), stage III disease, focal or diffuse anaplasia, or CCSK
Less than 30 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights
No Placebo-Only Group

Study Summary

This trial is testing proton therapy to treat renal tumors in the flank region to see if it is safe.

Who is the study for?
This trial is for patients under 30 years old with renal tumors, specifically Wilms tumor or clear cell sarcoma of the kidney (CCSK), who need radiation therapy as part of their standard care. It's not open to those who are pregnant, breastfeeding, have had previous radiotherapy in the cancer area, or chemotherapy for these diagnoses.Check my eligibility
What is being tested?
The study is testing how safe and tolerable proton beam radiation using pencil beam scanning is for treating renal tumors. This pilot study focuses on acute toxicity experienced by patients receiving this type of flank irradiation.See study design
What are the potential side effects?
While specific side effects aren't listed here, acute toxicity generally refers to immediate reactions from treatment such as skin irritation, fatigue, nausea or other organ-specific issues depending on the radiation target area.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with a specific kidney cancer that needs radiation.
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I am under 30 years old.
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I am eligible for a type of radiation therapy for my Wilms tumor or CCSK.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Occurrence of any non-hematologic toxicity that occurs within 90 days following the start of proton therapy assessed with with NCI Common toxicity criteria (CTC Version 4.0) grades].

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Renal tumorsExperimental Treatment1 Intervention
Any patient with Wilms tumor or clear cell sarcoma of the kidney who would require radiation therapy as standard of care. Patients may receive an investigation drug for Wilms or CCSK given concurrently or within the first four weeks of the first fraction of proton therapy administration.

Find a Location

Who is running the clinical trial?

Children's Hospital of PhiladelphiaLead Sponsor
700 Previous Clinical Trials
8,570,099 Total Patients Enrolled
Christine Hill-Kayser, MDPrincipal InvestigatorChildren's Hospital of Philadelphia
2 Previous Clinical Trials
55 Total Patients Enrolled

Media Library

Proton Beam Radiation (Proton Beam Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03810651 — Phase < 1
Kidney Tumors Research Study Groups: Renal tumors
Kidney Tumors Clinical Trial 2023: Proton Beam Radiation Highlights & Side Effects. Trial Name: NCT03810651 — Phase < 1
Proton Beam Radiation (Proton Beam Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03810651 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could I be considered as a volunteer for this medical experiment?

"This clinical trial is looking to enroll 25 individuals aged 0-30 who have been diagnosed with Wilms tumor. Furthermore, those hoping to participate must meet the following criteria: any patient with focal or diffuse anaplasia; less than 30 years of age; and any patient requiring radiation therapy as part of their standard medical care."

Answered by AI

Are there any vacancies in this clinical trial for participants?

"As per clinicaltrials.gov, recruitment for this trial is still ongoing. This medical study was initially posted on December 26th 2017 and the most recent edit of its details took place on July 28th 2022."

Answered by AI

Could those aged seventy-five and above partake in this research?

"The age range for this study is limited to those between 0 and 30 years old, as outlined in the criterion guidelines."

Answered by AI

How many persons can participate in this study at the maximum?

"Affirmative, the clinicaltrials.gov website is displaying that this research project has begun to recruit participants since December 26th 2017 and was last edited on July 28 2022. This trial looks for 25 individuals from a single centre."

Answered by AI
~2 spots leftby Jul 2024