Proton Therapy for Kidney Cancer

Overseen By Christine Hill-Kayser, MD

Age: < 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: Children's Hospital of Philadelphia

Disqualifiers: Prior radiotherapy, Chemotherapy, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

28 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a pilot study to assess acute toxicity in patients receiving flank irradiation using proton therapy for renal tumors.

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 data supports the effectiveness of the treatment Proton Therapy for Kidney Cancer?

Proton therapy is known for its ability to deliver precise radiation doses to tumors while minimizing damage to surrounding healthy tissues, which is beneficial for treating cancers in challenging locations. In a study involving various urological cancers, proton therapy was effective in controlling tumor size in patients with renal cell carcinoma, showing no tumor enlargement after treatment. ^{1 2 3 4 5}

Is proton therapy safe for treating kidney cancer?

Proton therapy has been used safely in a patient with inoperable kidney cancer, showing no severe side effects and only a slight decline in kidney function over a year. In children treated for other tumors, some kidney shrinkage was observed, but the other kidney often compensated by growing larger. ^{6 7 8 9 10}

How is proton therapy different from other treatments for kidney cancer?

Proton therapy is unique because it delivers radiation directly to the tumor with minimal exit dose, reducing damage to surrounding healthy tissues and potentially lowering the risk of side effects compared to conventional radiation treatments. This makes it a promising option for treating kidney cancer, especially in patients where preserving kidney function is crucial. ^{2 6 10 11 12}

Research Team

Christine Hill-Kayser, MD

Principal Investigator

Children's Hospital of Philadelphia

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: Renal tumors Experimental Treatment 1 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.

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:

• Cancer of the brain and spinal cord
• Eye melanoma
• Head and neck cancers
• Breast cancer
• Lung cancer
• Liver cancer
• Pancreatic cancer
• Prostate cancer

Approved in United States as Proton Beam Therapy for:

• Brain tumors
• Eye melanoma
• Head and neck cancers
• Breast cancer
• Lung cancer
• Liver cancer
• Pancreatic cancer
• Prostate cancer
• Pediatric cancers

Approved in Japan as Proton Radiotherapy for:

• Brain tumors
• Eye melanoma
• Head and neck cancers
• Breast cancer
• Lung cancer
• Liver cancer
• Pancreatic cancer
• Prostate cancer

Approved in Canada as Proton Therapy for:

• Brain tumors
• Eye melanoma
• Head and neck cancers
• Breast cancer
• Lung cancer
• Liver cancer
• Pancreatic cancer
• Prostate cancer

Who Is Running the Clinical Trial?

Children's Hospital of Philadelphia

Lead Sponsor

Trials

749

Recruited

11,400,000+

Findings from Research

Proton 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 urinary malignant tumors showing promising local control of the tumors.

While local control was achieved in all cases, some patients still experienced cancer progression or death, indicating that while proton therapy is effective, it may need to be combined with other treatments for optimal outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical study of proton radiotherapy in urological cancers]. Miyanaga, N., Ami, Y., Ohtani, M., et al.[2019]

Proton therapy offers significant advantages over traditional photon radiotherapy, particularly by minimizing damage to surrounding healthy tissues and reducing the risk of late toxicities and secondary cancers.

The development of smaller, cost-effective single-room proton therapy units has made this advanced treatment more accessible to cancer patients globally.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proton Therapy. LaRiviere, MJ., Santos, PMG., Hill-Kayser, CE., et al.[2020]

Proton beam therapy is recognized for its superior dose-distribution capabilities, particularly beneficial for treating deep-seated tumors near critical structures, making it the 'gold standard' for specific adult cancers like ocular melanoma and chordoma.

With over 60,000 patients treated globally, proton beam therapy is also being explored for pediatric cancers and other malignancies, showing promise in reducing side effects compared to conventional radiation therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Is proton beam therapy the future of radiotherapy? Part I: clinical aspects]. Bouyon-Monteau, A., Habrand, JL., Datchary, J., et al.[2018]

Proton beam therapy offers a more precise radiation dose distribution compared to conventional radiotherapy, resulting in less damage to surrounding healthy tissues and a lower incidence of treatment-related side effects.

Clinical evidence suggests that proton beam therapy has improved outcomes for specific cancers, such as uveal melanoma, skull-base or spinal sarcomas, and prostate cancer, but further extensive studies are needed to explore its benefits across more types of cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Proton beam therapy: clinical indications and summary of the Swiss experience]. Weber, DC., Mirimanoff, RO., Miralbell, R.[2018]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proton versus photon radiation therapy: A clinical review. Chen, Z., Dominello, MM., Joiner, MC., et al.[2023]

Proton stereotactic body radiation therapy (SBRT) was successfully used to treat a 47-year-old female patient with inoperable bilateral renal cell carcinoma (RCC), demonstrating its potential as a safe and effective treatment option for complex cases.

The patient experienced minimal acute side effects and maintained her renal function with only a slight decline in glomerular filtration rate (GFR) one year post-treatment, suggesting that proton therapy can preserve kidney function while effectively targeting tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First Ever Use of Proton Stereotactic Body Radiation Therapy Delivered with Curative Intent to Bilateral Synchronous Primary Renal Cell Carcinomas. Frick, MA., Chhabra, AM., Lin, L., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Retrospective Study of Renal Growth Changes after Proton Beam Therapy for Pediatric Malignant Tumor. Li, Y., Mizumoto, M., Oshiro, Y., et al.[2023]

In a study of 82 low-risk prostate cancer patients, those treated with hypofractionated proton-beam therapy (38 Gy in 5 treatments) and standard fractionation (79.2 Gy in 44 treatments) showed similar quality of life and urinary, bowel, and sexual function scores over 24 months.

Both treatment groups experienced excellent tolerance with no severe adverse events (grade 3 or higher), indicating that proton therapy is a safe option for prostate cancer treatment with comparable efficacy between the two fractionation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionated Versus Standard Fractionated Proton-beam Therapy for Low-risk Prostate Cancer: Interim Results of a Randomized Trial PCG GU 002. Vargas, CE., Hartsell, WF., Dunn, M., et al.[2019]

In a study of 151 patients with organ-confined prostate cancer, proton beam therapy (PBT) demonstrated a low incidence of late Grade 2 or greater rectal toxicities, reported at only 2.0% after 2 years of follow-up.

The study indicates that PBT is a safe treatment option for localized prostate cancer, with minimal acute and late toxicities, suggesting it can effectively control side effects while delivering targeted radiation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multi-institutional Phase II study of proton beam therapy for organ-confined prostate cancer focusing on the incidence of late rectal toxicities. Nihei, K., Ogino, T., Onozawa, M., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proton Therapy for Primary Renal Cell Carcinoma: The First Nationwide Retrospective Study in Japan. Fukumitsu, N., Ishikawa, H., Arimura, T., et al.[2021]

In a study of 20 patients with non-metastatic renal cell carcinoma treated with particle beam therapy (PBT), the 3-year overall survival rate was 100% and local control rate was 94.4%, with no severe toxicities observed over a median follow-up of 31 months.

Compared to photon-based stereotactic body radiotherapy (SBRT), PBT showed significantly better overall survival rates (94.3% for PBT vs. 75.3% for SBRT), suggesting that PBT may be a more effective treatment option for primary renal cancer, especially in cases where SBRT is not suitable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Japanese registry study and systematic review of particle therapy for renal cell carcinoma. Ishikawa, H., Arimura, T., Maruo, K., et al.[2023]

Proton therapy shows promise in treating cancer by delivering higher radiation doses directly to tumors while minimizing damage to surrounding healthy tissue, as indicated by 54 studies reviewed, including 4 randomized controlled trials.

One study found that proton therapy as a boost after conventional radiation for prostate cancer improved local control without increasing serious complications, although overall evidence remains low due to the predominance of non-controlled studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proton therapy - a systematic review of clinical effectiveness. Olsen, DR., Bruland, OS., Frykholm, G., et al.[2019]

References

1. Japan pubmed.ncbi.nlm.nih.gov

[Clinical study of proton radiotherapy in urological cancers]. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Proton Therapy. [2020]

3. France pubmed.ncbi.nlm.nih.gov

[Is proton beam therapy the future of radiotherapy? Part I: clinical aspects]. [2018]

4. France pubmed.ncbi.nlm.nih.gov

[Proton beam therapy: clinical indications and summary of the Swiss experience]. [2018]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Proton versus photon radiation therapy: A clinical review. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

First Ever Use of Proton Stereotactic Body Radiation Therapy Delivered with Curative Intent to Bilateral Synchronous Primary Renal Cell Carcinomas. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

A Retrospective Study of Renal Growth Changes after Proton Beam Therapy for Pediatric Malignant Tumor. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Hypofractionated Versus Standard Fractionated Proton-beam Therapy for Low-risk Prostate Cancer: Interim Results of a Randomized Trial PCG GU 002. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Multi-institutional Phase II study of proton beam therapy for organ-confined prostate cancer focusing on the incidence of late rectal toxicities. [2022]

10. Greece pubmed.ncbi.nlm.nih.gov

Proton Therapy for Primary Renal Cell Carcinoma: The First Nationwide Retrospective Study in Japan. [2021]

11. England pubmed.ncbi.nlm.nih.gov

A Japanese registry study and systematic review of particle therapy for renal cell carcinoma. [2023]

12. Ireland pubmed.ncbi.nlm.nih.gov

Proton therapy - a systematic review of clinical effectiveness. [2019]