28 Participants Needed

Proton Therapy for Kidney Cancer

RP
CH
Overseen ByChristine Hill-Kayser, MD
Age: < 65
Sex: Any
Trial Phase: Phase < 1
Sponsor: Children's Hospital of Philadelphia
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 4 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety of proton therapy, a type of radiation treatment, for kidney cancer in young patients. It targets those with conditions like Wilms tumor or clear cell sarcoma of the kidney who typically require radiation therapy. The study aims to identify any immediate side effects of this treatment. Individuals under 30 who need radiation for these specific kidney tumors might be suitable candidates for this study. As an Early Phase 1 trial, this research focuses on understanding how proton therapy affects young patients, offering them a chance to be among the first to receive this innovative treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that proton beam radiation is safe for treating renal tumors?

Research has shown that proton therapy is safe for people with kidney cancer. In one study, patients who received radiation for kidney tumors did not experience severe side effects. Some experienced only a slight decrease in kidney function, indicating that the treatment is generally well-tolerated. Another study found that patients who underwent proton therapy had fewer stomach and intestine problems, which are common with traditional radiation. These findings suggest that proton therapy might be a safer option for treating kidney cancer, with fewer immediate side effects compared to other treatments.12345

Why do researchers think this study treatment might be promising?

Proton beam radiation is unique for treating kidney cancer because it offers precision targeting of tumors while minimizing damage to surrounding healthy tissue. Unlike traditional radiation therapy, which uses X-rays, proton therapy uses positively charged particles that can be controlled more precisely, reducing side effects. This characteristic is particularly beneficial for patients with Wilms tumor or clear cell sarcoma of the kidney, as it allows for effective treatment with potentially fewer complications. Researchers are excited about this approach because it could enhance the quality of life for patients by preserving more of their healthy kidney function.

What evidence suggests that proton therapy is effective for kidney cancer?

Research has shown that proton beam therapy, the treatment under study in this trial, might be more effective than regular radiation for kidney tumors. One study found that proton therapy can focus radiation more precisely on the tumor, potentially protecting the surrounding healthy tissue. Another review noted that proton therapy usually causes fewer side effects than other radiation treatments. Although specific data for kidney cancer remains limited, early results suggest it could be a promising option.34678

Who Is on the Research Team?

CH

Christine Hill-Kayser, MD

Principal Investigator

Children's Hospital of Philadelphia

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am eligible for a type of radiation therapy for my Wilms tumor or CCSK.
I have been diagnosed with a specific kidney cancer that needs radiation.
I am under 30 years old.

Exclusion Criteria

I have received chemotherapy for Wilms tumor or CCSK.
Pregnant or breastfeeding
I have had radiation therapy on the cancer area being studied.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive pencil beam scanning proton therapy for renal tumors

4 weeks
Weekly visits for radiation sessions

Follow-up

Participants are monitored for acute toxicity and effectiveness after radiation therapy

12 weeks
Regular visits for toxicity assessment

What Are the Treatments Tested in This Trial?

Interventions

  • Proton Beam Radiation
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Renal tumorsExperimental Treatment1 Intervention

Proton Beam Radiation is already approved in European Union, United States, Japan, Canada for the following indications:

🇪🇺
Approved in European Union as Proton Therapy for:
🇺🇸
Approved in United States as Proton Beam Therapy for:
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Approved in Japan as Proton Radiotherapy for:
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Approved in Canada as Proton Therapy for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Children's Hospital of Philadelphia

Lead Sponsor

Trials
749
Recruited
11,400,000+

Published Research Related to This Trial

In a study of 11 pediatric patients who underwent proton beam therapy (PBT) for malignant tumors, irradiated kidneys showed significant volume reduction over time, indicating continuous atrophy, particularly in older children and with higher radiation doses.
The degree of kidney atrophy was correlated with the volume of radiation exposure, suggesting that careful planning of treatment doses and volumes is crucial to minimize long-term renal effects in young patients.
A Retrospective Study of Renal Growth Changes after Proton Beam Therapy for Pediatric Malignant Tumor.Li, Y., Mizumoto, M., Oshiro, Y., et al.[2023]
Proton radiation therapy has better dose distribution characteristics than photon radiation therapy, which could lead to improved treatment outcomes in certain clinical applications.
However, there is still a lack of substantial clinical evidence demonstrating clear advantages of proton therapy over more affordable photon treatments, partly due to the smaller number of patients receiving proton therapy.
Proton versus photon radiation therapy: A clinical review.Chen, Z., Dominello, MM., Joiner, MC., et al.[2023]
In a study of 22 renal cell carcinoma patients treated with proton beam therapy (PBT) over a median follow-up of 37 months, the 3-year overall survival rate was 95% and disease-specific survival was 100%, indicating high efficacy of PBT for this cancer.
No patients experienced severe adverse effects (grade 3 or higher), and while there was a slight reduction in kidney function, PBT was able to maintain renal function, suggesting it is a safe and effective treatment option, especially for inoperable cases.
Proton Therapy for Primary Renal Cell Carcinoma: The First Nationwide Retrospective Study in Japan.Fukumitsu, N., Ishikawa, H., Arimura, T., et al.[2021]

Citations

Proton Therapy for Kidney CancerProton beam therapy was found to be superior to photon beam therapy in concentrating the radiation dose within tumors, with a study involving 15 patients with ...
Pencil Beam Scanning Proton Beam Radiation Therapy in ...This pilot trial studies how well pencil beam scanning proton therapy works in treating patients with kidney tumors. Usual treatment for patients with ...
Innovative radiotherapy of sarcoma: Proton beam radiationThis review on proton beam radiotherapy (PBT) focusses on an historical overview, cost-effectiveness, techniques, acute and late toxicities and clinical results
Treating kidney cancer without surgeryResearch has also demonstrated that proton SBRT can be an effective treatment for people with kidney cancer. Proton therapy radiates fewer ...
Mechanisms and review of clinical evidence for variations in ...Proton therapy is increasingly being used as a radiation therapy modality. There is uncertainty about the biological effectiveness of protons ...
Pencil Beam Scanning in Patients With Renal TumorsThis pilot study evaluates pencil beam scanning proton therapy (PBS-PT) to: result in low acute gastrointestinal toxicity in patients receiving radiation ...
228 Conformal Pencil Beam Scanning Proton Therapy for ...Patients (pts) were enrolled on Phase II trial with IRB approval; eligibility included Wilms tumor or clear cell sarcoma of kidney (CCSK) requiring flank-only ...
Pencil Beam Scanning in Patients With Renal TumorsThis is a pilot study to assess acute toxicity in patients receiving flank irradiation using proton therapy for renal tumors. Eligibility Criteria. Inclusion ...
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