Proton vs Photon Radiotherapy for Head and Neck Cancer

Recruiting in Palo Alto (17 mi)

+10 other locations

Overseen by Nancy Lee, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

Compared to IMRT, PBRT is thought to give less radiation exposure to the surrounding healthy tissues. It is possible that side effect rates with PBRT will be lower or the same compared to IMRT, but this has not been well studied to date. Although both of these radiation therapies have been used in the past to treat head and neck cancer, this research study will compare the effects of these two different radiation treatment modalities with each other to see whether PBRT is better, the same or worse than IMRT.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the idea that Proton vs Photon Radiotherapy for Head and Neck Cancer is an effective treatment?

The available research shows that Proton Beam Radiation Therapy (PBRT) is effective for treating head and neck cancer because it reduces the damage to healthy tissues compared to Photon Intensity Modulated Radiation Therapy (IMRT). Studies indicate that PBRT results in fewer side effects and better protection of important areas like the mandible, which is the jawbone. Additionally, Proton Therapy has shown promising initial results in treating head and neck tumors, with ongoing trials to further confirm its benefits. Overall, Proton Therapy appears to offer better outcomes by targeting the cancer more precisely and sparing healthy tissues. ^{1 2 3 4 5}

What safety data exists for proton and photon radiotherapy in head and neck cancer?

Proton beam radiation therapy (PBRT) is associated with significantly reduced toxicity compared to intensity-modulated radiation therapy (IMRT) for head and neck tumors. Proton therapy allows for better sparing of normal tissues due to its superior dose localization properties, potentially leading to fewer acute and long-term treatment-related toxicities. Initial clinical experiences with proton therapy are promising, and ongoing trials aim to further define its role. Studies have shown that intensity-modulated proton therapy (IMPT) can reduce the dose to organs at risk compared to IMRT, which may result in lesser treatment-related toxicity and improved quality of life. ^{1 2 3 5 6}

Is Proton Beam Therapy a promising treatment for head and neck cancer?

Yes, Proton Beam Therapy is promising for head and neck cancer because it can target tumors more precisely, reducing damage to nearby healthy tissues. This means patients may experience fewer side effects compared to traditional radiation treatments. ^{1 2 3 5 7}

Research Team

Nancy Lee, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for adults over 18 with certain types of head and neck cancer, including salivary gland, skin cancer, melanoma, or HNSCC requiring one-sided radiation. Participants must be in good physical condition (Karnofsky score ≥70) and women able to have children must not be pregnant.

Inclusion Criteria

I have been diagnosed with salivary gland cancer, skin cancer, melanoma, or head and neck cancer needing radiation on one side.

I am a woman under 51 and have a negative pregnancy test.

I am 18 years old or older.

Exclusion Criteria

My doctor has recommended radiation therapy for my mucosal surfaces.

My condition cannot be treated with surgery.

My doctor has recommended radiation therapy for both sides of my neck.

Treatment Details

Interventions

• Photon intensity modulated radiation therapy (IMRT) (Photon Therapy)
• Proton beam radiotherapy (PBRT) (Proton Beam Therapy)

Trial Overview The study compares two types of radiation therapy: Photon IMRT and Proton PBRT. It aims to determine if PBRT results in fewer side effects by reducing exposure to healthy tissues compared to the more traditional IMRT method.

Participant Groups

Group I: Proton beam radiotherapy (PBRT) Experimental Treatment 1 Intervention

PBRT to standard dose of 60-66Gy

Group II: Photon intensity modulated radiation therapy (IMRT) Experimental Treatment 1 Intervention

IMRT to standard dose of 60-66Gy

Photon intensity modulated radiation therapy (IMRT) is already approved in Canada, Japan, China, Switzerland for the following indications:

Approved in Canada as Intensity Modulated Radiation Therapy for:

• Head and neck cancer
• Brain tumors
• Breast cancer
• Esophageal cancer
• Gynecological cancers
• Liver cancer
• Lung cancer
• Pancreatic cancer
• Prostate cancer

Approved in Japan as Intensity Modulated Radiation Therapy for:

• Head and neck cancer
• Brain tumors
• Breast cancer
• Esophageal cancer
• Gynecological cancers
• Liver cancer
• Lung cancer
• Pancreatic cancer
• Prostate cancer

Approved in China as Intensity Modulated Radiation Therapy for:

• Head and neck cancer
• Brain tumors
• Breast cancer
• Esophageal cancer
• Gynecological cancers
• Liver cancer
• Lung cancer
• Pancreatic cancer
• Prostate cancer

Approved in Switzerland as Intensity Modulated Radiation Therapy for:

• Head and neck cancer
• Brain tumors
• Breast cancer
• Esophageal cancer
• Gynecological cancers
• Liver cancer
• Lung cancer
• Pancreatic cancer
• Prostate cancer

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Lisa M. DeAngelis

Memorial Sloan Kettering Cancer Center

Chief Medical Officer since 2021

MD from Columbia University

Selwyn M. Vickers

Memorial Sloan Kettering Cancer Center

Chief Executive Officer since 2022

MD from Johns Hopkins University

Mayo Clinic

Collaborator

Trials

3,427

Recruited

3,221,000+

Dr. Gianrico Farrugia

Mayo Clinic

Chief Executive Officer since 2019

MD from University of Malta Medical School

Dr. Richard Afable

Mayo Clinic

Chief Medical Officer

MD from Loyola Stritch School of Medicine

Mount Sinai Hospital, New York

Collaborator

Trials

37

Recruited

892,000+

Findings from Research

Proton beam radiation therapy (PBRT) significantly spares normal tissues compared to intensity-modulated radiation therapy (IMRT), as shown by lower radiation doses to critical structures like the brainstem and spinal cord in a study of 41 patients with head and neck cancers.

Patients receiving PBRT experienced significantly lower rates of acute treatment-related toxicities, including dysgeusia, mucositis, and nausea, indicating that PBRT may be a safer option for treating ipsilateral head and neck cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proton beam radiation therapy results in significantly reduced toxicity compared with intensity-modulated radiation therapy for head and neck tumors that require ipsilateral radiation. Romesser, PB., Cahlon, O., Scher, E., et al.[2022]

Proton beam radiation therapy (PBRT) significantly reduces radiation exposure to healthy tissues in the mandible compared to intensity-modulated radiation therapy (IMRT), with much lower doses to critical areas like the oropharynx and parotid glands.

The study, which evaluated dosimetric distributions in patients with head and neck cancer receiving ≥60 Gy of PBRT, suggests that PBRT may lead to less radiation-related toxicity, making it a safer option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of mean radiation dose and dosimetric distribution to tooth-bearing regions of the mandible associated with proton beam radiation therapy and intensity-modulated radiation therapy for ipsilateral head and neck tumor. Owosho, AA., Yom, SK., Han, Z., et al.[2018]

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]

In a study of 68 patients with head and neck squamous cell carcinoma treated with particle beam radiotherapy (PBRT), the 3-year overall survival rate was 79.0%, indicating promising therapeutic outcomes.

While PBRT showed manageable toxicity, with only a few cases of severe mucositis and late mucosal necrosis, the results suggest that PBRT could be a beneficial treatment option for HNSCC, warranting further prospective studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary clinical outcomes of head and neck squamous cell carcinoma treated with particle beam radiation therapy. Huang, Q., Hu, J., Hu, W., 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 is safer for patients with head and neck cancer as it reduces damage to normal tissues compared to traditional intensity-modulated photon therapy, leading to less treatment-related toxicity and better quality of life.

A phase II/III randomized trial is currently comparing the effectiveness of proton therapy versus photon therapy for advanced-stage oropharyngeal tumors, with a focus on progression-free survival as the main measure of success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing Intensity-Modulated Proton Therapy With Intensity-Modulated Photon Therapy for Oropharyngeal Cancer: The Journey From Clinical Trial Concept to Activation. Frank, SJ., Blanchard, P., Lee, JJ., et al.[2020]

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]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Proton beam radiation therapy results in significantly reduced toxicity compared with intensity-modulated radiation therapy for head and neck tumors that require ipsilateral radiation. [2022]

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

Comparison of mean radiation dose and dosimetric distribution to tooth-bearing regions of the mandible associated with proton beam radiation therapy and intensity-modulated radiation therapy for ipsilateral head and neck tumor. [2018]

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

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

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

Preliminary clinical outcomes of head and neck squamous cell carcinoma treated with particle beam radiation therapy. [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

Comparing Intensity-Modulated Proton Therapy With Intensity-Modulated Photon Therapy for Oropharyngeal Cancer: The Journey From Clinical Trial Concept to Activation. [2020]

7. England pubmed.ncbi.nlm.nih.gov

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