Proton Therapy for Head and Neck Cancer

Overseen By Catherine Duke-Taylor, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Thompson Cancer Survival Center

Disqualifiers: Prior radiotherapy, Children, Pregnant women, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 10 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to reduce skin reactions during proton therapy, a treatment for head and neck cancers. Researchers are testing a new method called "Spot Delete" to determine if it lessens the severity of skin reactions. They also seek to understand how the proton beam's energy influences these reactions. Suitable patients have been diagnosed with specific types of head and neck cancer, such as squamous cell carcinoma, and do not have serious health conditions that could interfere with treatment. As an unphased trial, this study allows patients to contribute to innovative research that could enhance future cancer treatments.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, previous or concurrent chemotherapy is allowed, suggesting some medications may be continued.

What prior data suggests that this technique is safe for head and neck cancer patients?

Research has shown that proton therapy, including a method called pencil beam scanning (PBS), is generally safer than traditional radiation treatments. It typically causes fewer issues in healthy tissues, reducing harm to non-cancerous parts of the body.

Studies have found that PBS proton therapy often results in fewer side effects. Patients report a positive experience regarding safety and quality of life, making it a promising option for treating cancers, such as those in the head and neck area.

Overall, PBS proton therapy is well-tolerated. Its precise targeting helps protect healthy tissues from unnecessary exposure. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Proton beam therapy (PBS Proton Therapy) is unique because it uses charged particles called protons instead of traditional X-rays to target head and neck cancer. This method allows for more precise delivery of radiation, which can minimize damage to surrounding healthy tissues and reduce side effects. Researchers are excited about this treatment because it has the potential to improve outcomes by focusing the radiation more accurately on the tumor, offering a promising alternative to conventional radiation therapies.

What evidence suggests that this technique is effective for reducing skin reactions in head and neck cancer patients?

Research has shown that PBS proton therapy for head and neck cancer is very promising. Studies have found that it protects important organs near the cancer, reducing harm to healthy tissues. Patients who received PBS proton therapy experienced excellent cancer control and fewer long-term side effects. This suggests that PBS proton therapy could be an effective and safer option compared to traditional radiation treatments for head and neck cancers. ^{1 2 6 7 8}

Who Is on the Research Team?

Samantha Hedrick, PhD, DABR

Principal Investigator

Thompson Proton Center, Director of Medical Physics

Are You a Good Fit for This Trial?

This trial is for individuals with various types of head and neck cancers, including oral squamous cell carcinoma. Participants must be suitable candidates for pencil beam scanning (PBS) proton therapy.

Inclusion Criteria

My cancer is a type of squamous cell carcinoma located in my mouth, throat, or related areas.

My neck cancer is p16 positive but its primary origin is unknown.

I have had surgery before to remove cancer in my head or neck.

Exclusion Criteria

I am a child.

I have had radiation in the same area where my current cancer is located.

I am currently pregnant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive pencil beam scanning (PBS) proton therapy with the 'Spot Delete' technique to reduce skin reactions

10 weeks

Weekly assessments

Follow-up

Participants are monitored for skin reactions and effectiveness of the 'Spot Delete' technique post-treatment

6 months

1 month and 6 months post-treatment assessments

Long-term Follow-up

Comparisons of skin reactions and LET values conducted over a 5-year period

5 years

What Are the Treatments Tested in This Trial?

Interventions

• PBS Proton Therapy

Trial Overview The study tests a 'Spot Delete' technique during PBS proton therapy to see if it reduces skin reactions in patients with head & neck cancer. It also examines how the energy transfer from protons affects these reactions.

PBS Proton Therapy is already approved in United States, European Union, Japan for the following indications:

Approved in United States as Proton Beam Therapy for:

• Head and neck cancers
• Brain tumors
• Spinal tumors
• Pediatric cancers

Approved in European Union as Proton Beam Therapy for:

• Head and neck cancers
• Brain tumors
• Spinal tumors
• Pediatric cancers
• Eye tumors

Approved in Japan as Proton Beam Therapy for:

• Head and neck cancers
• Brain tumors
• Spinal tumors
• Pediatric cancers
• Hepatocellular carcinoma

Who Is Running the Clinical Trial?

Thompson Cancer Survival Center

Lead Sponsor

Trials

4

Recruited

800+

Published Research Related to This Trial

Proton beam therapy offers significant advantages over traditional photon techniques in treating head and neck cancer due to its precision in targeting tumors while sparing surrounding sensitive organs.

Recent clinical data supports the benefits of proton therapy in reducing toxicity, which is especially important for young patients with HPV-associated cancers who may face long-term side effects from radiation treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proton therapy for head and neck cancer: expanding the therapeutic window. Leeman, JE., Romesser, PB., Zhou, Y., et al.[2019]

Pencil beam scanning (PBS) proton therapy significantly reduces radiation exposure to critical structures such as the temporal lobe, oral cavity, and mandible compared to intensity-modulated radiation therapy (IMRT), indicating a safer treatment option for patients with parotid gland cancers.

PBS maintains excellent coverage of the target area while sparing normal tissues, suggesting it may improve the therapeutic index and potentially enhance patient quality of life, warranting further prospective clinical evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Pencil Beam Scanning Proton- and Photon-Based Techniques for Carcinoma of the Parotid. Swisher-McClure, S., Teo, BK., Kirk, M., et al.[2022]

Proton therapy (PT) is a highly advanced radiation treatment that offers significant advantages over traditional photon methods, particularly for head and neck cancers (HNC), due to its unique dosimetric properties like the Bragg peak.

The review highlights PT's effectiveness in treating various tumors, including those in the skull base and eye, and suggests that its continued development could lead to improved outcomes for oncology patients, especially those with HNC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proton Therapy in Head and Neck Cancer Treatment: State of the Problem and Development Prospects (Review). Gordon, KB., Smyk, DI., Gulidov, IA.[2022]

Proton pencil beam scanning (PBS) therapy significantly reduces the risk of secondary cancers in breast cancer patients compared to traditional photon therapies, with a notable reduction in risk for younger patients with nodal involvement.

In a study involving 10 breast cancer patients, PBS showed a lower cumulative excess absolute risk for secondary cancers in the lungs and contralateral breast compared to tangential 3D-CRT and VMAT, highlighting its potential as a safer treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proton pencil beam scanning reduces secondary cancer risk in breast cancer patients with internal mammary chain involvement compared to photon radiotherapy. Cartechini, G., Fracchiolla, F., Menegotti, L., et al.[2021]

Proton therapy (PT) shows promise in improving treatment outcomes for patients with squamous cell carcinoma of the head and neck by minimizing damage to healthy tissues compared to traditional photon-based treatments.

Despite the potential benefits, current evidence for PT in HNSCC is limited to dosimetric analyses and retrospective studies, leading to challenges in gaining broader reimbursement and acceptance in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proton Therapy for Squamous Cell Carcinoma of the Head and Neck: Early Clinical Experience and Current Challenges. Nuyts, S., Bollen, H., Ng, SP., et al.[2022]

Proton beam therapy using pencil beam scanning with a patient-specific aperture system (PBS with PSAS) showed the best dose conformity for treating non-squamous cell carcinoma of the head and neck among the methods tested, including passive-scattering proton therapy and X-ray intensity-modulated radiotherapy.

Patients treated with PBS and PSAS experienced manageable side effects, with no severe acute dermatitis reported, and quality of life metrics returned to baseline levels within 12 months post-treatment, indicating good tolerance and recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proton therapy for non-squamous cell carcinoma of the head and neck: planning comparison and toxicity. Iwata, H., Toshito, T., Hayashi, K., et al.[2020]

Proton therapy with pencil beam scanning (PBS) shows greater potential for sparing normal tissue compared to intensity-modulated photon radiation (IMRT) in patients requiring postoperative radiotherapy after endoscopic resection of skull base tumors.

The study suggests that using PBS in the postoperative setting can lead to improved protection of critical organs, indicating a promising approach to reduce treatment-related toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic Resection Followed by Proton Therapy With Pencil Beam Scanning for Skull Base Tumors. Leeman, JE., Lee, NY., Zhou, Y., et al.[2020]

In a study of 11 women with gynecologic cancers receiving pencil beam scanning (PBS) proton therapy, the treatment showed a low incidence of acute toxicities, with only 33% experiencing grade 2 hematologic toxicities and 9% experiencing grade 3 gastrointestinal toxicity, indicating a relatively safe profile.

PBS demonstrated significant dosimetric advantages over intensity-modulated radiation therapy (IMRT), particularly in sparing surrounding normal tissues like pelvic bone marrow, bladder, and small bowel from low doses, while maintaining robust target coverage despite setup uncertainties.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial Report of Pencil Beam Scanning Proton Therapy for Posthysterectomy Patients With Gynecologic Cancer. Lin, LL., Kirk, M., Scholey, J., et al.[2020]

In a study involving 11 patients with rectal cancer, preoperative short-course pencil beam scanning proton therapy (PBS-PT) effectively reduced radiation exposure to normal tissues compared to traditional photon therapies (3DCRT and VMAT).

PBS-PT provided similar coverage of the clinical target volume while significantly lowering the radiation dose to critical organs like the small and large bowel, bladder, and femoral heads, suggesting a safer treatment option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Implementation of Preoperative Short-Course Pencil Beam Scanning Proton Therapy for Patients With Rectal Cancer. Jeans, EB., Jethwa, KR., Harmsen, WS., et al.[2022]

In a study of 304 men with localized prostate cancer, those treated with pencil beam scanning (PBS) showed a higher proportion of significant declines in urinary quality of life (QOL) compared to those treated with passive scatter/uniform scanning (PS/US) at 12 months, indicating a potential difference in outcomes between the two proton therapy methods.

However, overall average quality-of-life declines did not significantly differ between PBS and PS/US, suggesting that while there may be specific areas of concern, both treatment modalities have similar average effects on patient-reported outcomes over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient reported outcomes following proton pencil beam scanning vs. passive scatter/uniform scanning for localized prostate cancer: Secondary analysis of PCG 001-09. Mishra, MV., Khairnar, R., Bentzen, SM., et al.[2022]

In a study involving 14 pediatric patients, pencil beam scanning (PBS) proton therapy did not show a clear dosimetric advantage over passive scattering proton therapy (PSPT) when using larger spot sizes, as it resulted in a higher average dose to healthy organs.

However, using smaller spot sizes in PBS significantly improved treatment quality by reducing the mean dose to healthy tissues and normal tissue complication probability, suggesting that smaller spots and the addition of apertures can enhance the safety and efficacy of proton therapy for complex tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Spot Size and Beam-Shaping Devices on the Treatment Plan Quality for Pencil Beam Scanning Proton Therapy. Moteabbed, M., Yock, TI., Depauw, N., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11579081/

Proton Therapy in The Treatment of Head And Neck Cancers Proton therapy represents a promising alternative to conventional radiotherapy due to the reduced number of complications in healthy tissues.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1368837520303158

Review Past, present and future of proton therapy for head ... 1). In head and neck cancer treatment, proton beam's advantage provides particular benefit in protecting major organs at risk (OARs) that are usually close to ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10392657/

Clinical outcome after pencil beam scanning proton ... Our data suggest excellent oncological outcome and low late toxicity rates for patients with SGT treated with PBSPT.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0360301623063836

3300 Outcomes of Patients Treated with Re-Irradiation for ... We describe clinical outcomes and toxicity of pencil beam scanning proton therapy (PBS-PT) for recurrent HNC. Materials/Methods. We performed a retrospective ...

5. tro.amegroups.org tro.amegroups.org/article/view/7608/html

Recent progress in pencil beam scanning FLASH proton therapy This review summarizes of recent developments in PBS FLASH proton therapy (FLASH-PT), including PBS dose rate characterization, current delivery limitations, ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1120179724011116

Assessment of pencil beam scanning proton therapy ... This study focuses on automating the evaluation of beam delivery accuracy using irradiation log files and machine learning (ML) models.

7. withpower.com withpower.com/trial/phase-head-and-neck-carcinoma-11-2023-cf5ec

Proton Therapy for Head and Neck Cancer Proton therapy, including pencil beam scanning (PBS), has been studied for various cancers and generally shows a potential for reduced side effects compared to ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT02452021

Pencil Beam Scanning Proton Radiotherapy for ... The investigators hypothesize that PBS proton RT will be associated with a favorable adverse event profile and quality of life, with similar disease control ...