Proton Therapy for Head and Neck Cancer

Recruiting at 9 trial locations

Overseen By Clinical Trials Referral Office

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Mayo Clinic

Must not be taking: Antiretrovirals, Investigational agents

Disqualifiers: Immunocompromised, Active infection, Cardiac issues, others

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

Prior Safety Data This treatment has passed at least one previous human trial

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

Compensation: Varies

Number of Visits: 19

Duration: 3-4 weeks

174 Participants Needed

Trial Summary

What is the purpose of this trial?

This clinical trial studies how well intensity modulated proton therapy (IMPT) or intensity modulated X-ray (radiation) therapy (IMRT) works after surgery in treating patients with head and neck cancer. IMPT is a type of radiation therapy that allows for the most accurate application of proton radiation to the tumor and has the potential to reduce treatment-related side effects. IMRT is a type of 3-dimensional radiation therapy that uses computer-generated images to show the size and shape of the tumor. Thin beams of x-ray radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor. IMPT may work as well as IMRT after surgery in treating patients with head and neck cancer.

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 Intensity-Modulated Proton Therapy (IMPT) for head and neck cancer?

Research shows that Intensity-Modulated Proton Therapy (IMPT) can better target tumors in the head and neck area while reducing radiation exposure to nearby healthy organs, which may lead to fewer side effects like reduced need for feeding tubes. Initial studies suggest that IMPT might improve tumor control and reduce treatment-related toxicity compared to traditional radiation methods. ^{1 2 3 4 5}

Is proton therapy safe for treating head and neck cancer?

Proton therapy, including intensity-modulated proton therapy (IMPT), is generally considered safe for treating head and neck cancer. It has been shown to reduce radiation exposure to healthy tissues compared to traditional photon therapy, potentially leading to fewer side effects like pain, dry mouth, and difficulty swallowing. ^{2 3 4 5 6}

How does the treatment Intensity-Modulated Proton Therapy (IMPT) for head and neck cancer differ from other treatments?

Intensity-Modulated Proton Therapy (IMPT) is unique because it uses protons instead of traditional photon radiation, allowing for more precise targeting of tumors while sparing nearby healthy tissues. This can lead to fewer side effects, such as reduced damage to salivary glands and less need for feeding tubes, compared to conventional radiation therapies. ^{1 2 3 5 7}

Research Team

Scott C. Lester, M.D.

Principal Investigator

Mayo Clinic in Rochester

Eligibility Criteria

Adults with non-HPV head and neck cancers, including oral, paranasal sinus, salivary gland, skin cancer, etc., who have good blood counts and organ function. They must be COVID-19 negative or recovered and not immunocompromised (except stable HIV). Pregnant women and those with recent heart issues or other active cancers are excluded.

Inclusion Criteria

My cancer is in my head or neck area, including the mouth and throat.

My scans show no signs of cancer spread beyond its original site.

My cancer in the head or neck is not related to HPV.

Exclusion Criteria

I have not had any other cancer within the last 2 years.

I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

Pregnant women (serum pregnancy test required before treatment per department policy)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Patients undergo IMPT or IMRT for 15-18 sessions over 19-24 days, with optional cisplatin administration

3-4 weeks

15-18 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 10 years

Regular visits at months 3, 6, 9, 12, 15, 18, 24, 35, 48, and 60

Long-term Follow-up

Monitoring of long-term outcomes such as survival and recurrence rates

Up to 10 years

Treatment Details

Interventions

• Intensity-Modulated Proton Therapy

Trial Overview The trial is testing intensity-modulated proton therapy as a post-surgery treatment to reduce tumor size in patients with various types of head and neck cancer. It includes cisplatin chemotherapy alongside radiation therapy using high-energy protons.

Participant Groups

Group I: Arm C (IMRT, cisplatin) Experimental Treatment 8 Interventions

Patients undergo IMRT for 15 sessions over 19 days in the absence of disease progression or unacceptable toxicity. Patients may receive cisplatin IV over 1-2 hours per standard of care. Patients undergo CT or MRI and PET/CT or PET/MRI during screening and follow-up. Patients may also undergo blood sample collection throughout the trial.

Group II: Arm B (IMPT, cisplatin) Experimental Treatment 8 Interventions

Patients undergo IMPT for 15 sessions over 19 days in the absence of disease progression or unacceptable toxicity. Patients may receive cisplatin IV over 1-2 hours per standard of care. Patients undergo CT or MRI and PET/CT or PET/MRI during screening and follow-up. Patients may also undergo blood sample collection throughout the trial.

Group III: Arm A (IMPT, IMRT, cisplatin) Experimental Treatment 9 Interventions

Patients undergo IMPT or IMRT for 18 sessions over 24 days in the absence of disease progression or unacceptable toxicity. Patients may receive cisplatin IV over 1-2 hours per standard of care. Patients undergo CT or MRI and PET/CT or PET/MRI during screening and follow-up. Patients may also undergo blood sample collection throughout the trial.

Intensity-Modulated Proton Therapy is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as IMPT for:

• Head and neck cancers
• Squamous cell carcinoma
• Nasopharyngeal cancer
• Oropharyngeal cancer
• Thyroid cancer
• Salivary gland cancer

Approved in European Union as IMPT for:

• Head and neck cancers
• Squamous cell carcinoma
• Nasopharyngeal cancer
• Oropharyngeal cancer
• Thyroid cancer
• Salivary gland cancer

Approved in Canada as IMPT for:

• Head and neck cancers
• Squamous cell carcinoma
• Nasopharyngeal cancer
• Oropharyngeal cancer
• Thyroid cancer
• Salivary gland cancer

Approved in Japan as IMPT for:

• Head and neck cancers
• Squamous cell carcinoma
• Nasopharyngeal cancer
• Oropharyngeal cancer
• Thyroid cancer
• Salivary gland cancer

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

Intensity modulated proton therapy (IMPT) shows significant dosimetric advantages over traditional intensity modulated radiation therapy (IMRT) for head and neck cancers, particularly in sparing nearby organs like the larynx and salivary glands.

Clinical evidence suggests that IMPT can reduce treatment-related toxicities, such as the need for feeding tubes, indicating its potential benefits in improving patient quality of life during and after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensity modulated proton therapy (IMPT) - The future of IMRT for head and neck cancer. Moreno, AC., Frank, SJ., Garden, AS., et al.[2020]

Proton radiation therapy, particularly intensity-modulated proton therapy (IMPT), offers better dose localization compared to conventional photon radiation therapy, potentially reducing damage to surrounding healthy tissues in patients with head and neck and skull base tumors.

Initial clinical experiences suggest that IMPT may lead to fewer acute and long-term toxicities, and ongoing multi-institutional trials aim to further establish its effectiveness in treating these complex tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proton radiation therapy for head and neck cancer. Chan, AW., Liebsch, NJ.[2018]

Intensity-modulated proton therapy (IMPT) offers significant dosimetric advantages over traditional photon radiation therapy, allowing for higher doses to be delivered to tumors while sparing critical surrounding organs, which may lead to reduced toxicity.

Existing evidence suggests that IMPT can improve patient-reported outcomes, reduce malnutrition, and decrease the need for gastrostomy tubes in patients with head and neck cancers, highlighting its potential benefits in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduced acute toxicity and improved efficacy from intensity-modulated proton therapy (IMPT) for the management of head and neck cancer. McKeever, MR., Sio, TT., Gunn, GB., et al.[2017]

Intensity modulated proton beam therapy (IMPT) significantly reduces the average radiation dose to tooth-bearing regions in head and neck cancer patients compared to photon-based volumetric modulated arc therapy (VMAT), indicating a safer option for preserving dental health during treatment.

In a study of 121 patients, factors such as oral cavity tumors and advanced T3-T4 tumors were identified as risk factors for receiving a cumulative radiation dose of ≥40 Gy to tooth-bearing areas, which is critical for determining the need for prophylactic dental extractions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Planned dose of intensity modulated proton beam therapy versus volumetric modulated arch therapy to tooth-bearing regions. Alberga, JM., Meijer, J., Raghoebar, GM., et al.[2023]

Intensity-modulated proton therapy (IMPT) for oropharyngeal carcinoma shows a potential reduction in severe weight loss and feeding tube dependency compared to intensity-modulated radiotherapy (IMRT), based on a study of 150 matched patients with a median follow-up of 32 months.

Despite these benefits, there were no significant differences in overall survival or progression-free survival between IMPT and IMRT, indicating that IMPT does not compromise treatment effectiveness while potentially improving quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensity-modulated proton beam therapy (IMPT) versus intensity-modulated photon therapy (IMRT) for patients with oropharynx cancer - A case matched analysis. Blanchard, P., Garden, AS., Gunn, GB., et al.[2022]

Intensity-modulated proton therapy (IMPT) shows promise in treating HPV-associated oropharyngeal squamous cell carcinoma (OPC) by reducing side effects while maintaining effective treatment for the tumor, as it spares normal tissues from high radiation doses.

Retrospective studies indicate that IMPT results in lower rates of complications such as pain, dry mouth, and difficulty swallowing compared to traditional X-ray radiotherapy, which can significantly improve the quality of life for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proton Therapy for HPV-Associated Oropharyngeal Cancers of the Head and Neck: a De-Intensification Strategy. Taku, N., Wang, L., Garden, AS., et al.[2022]

Intensity-modulated proton therapy (IMPT) significantly reduced the radiation dose to the parotid glands compared to both intensity-modulated radiotherapy with photons (IMRT) and three-dimensional conformal radiotherapy (3D-CRT), suggesting a potential for less salivary dysfunction and xerostomia in patients with oropharyngeal cancer.

While IMPT and IMRT provided similar coverage of the target areas, IMPT showed improved conformity in sparing surrounding healthy tissues, indicating a theoretical clinical benefit that needs further validation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential benefits of scanned intensity-modulated proton therapy versus advanced photon therapy with regard to sparing of the salivary glands in oropharyngeal cancer. van de Water, TA., Lomax, AJ., Bijl, HP., et al.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Intensity modulated proton therapy (IMPT) - The future of IMRT for head and neck cancer. [2020]

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

Proton radiation therapy for head and neck cancer. [2018]

3. China pubmed.ncbi.nlm.nih.gov

Reduced acute toxicity and improved efficacy from intensity-modulated proton therapy (IMPT) for the management of head and neck cancer. [2017]

4. England pubmed.ncbi.nlm.nih.gov

Planned dose of intensity modulated proton beam therapy versus volumetric modulated arch therapy to tooth-bearing regions. [2023]

5. Ireland pubmed.ncbi.nlm.nih.gov

Intensity-modulated proton beam therapy (IMPT) versus intensity-modulated photon therapy (IMRT) for patients with oropharynx cancer - A case matched analysis. [2022]

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

Proton Therapy for HPV-Associated Oropharyngeal Cancers of the Head and Neck: a De-Intensification Strategy. [2022]

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

Potential benefits of scanned intensity-modulated proton therapy versus advanced photon therapy with regard to sparing of the salivary glands in oropharyngeal cancer. [2018]