Proton Therapy for Recurrent Head and Neck Cancer

Recruiting at 11 trial locations

Overseen By Han Xiao, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Pregnancy, Lactation, Recent radiation, 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

Compensation: Varies

Number of Visits: Unknown

Duration: 6-8 weeks

87 Participants Needed

Trial Summary

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 this with the trial coordinators or your doctor.

What data supports the effectiveness of this treatment for recurrent head and neck cancer?

Research suggests that intensity-modulated proton therapy (IMPT) can reduce damage to nearby healthy organs compared to traditional radiation methods, potentially leading to fewer side effects like reduced feeding tube dependency. This is due to the precise targeting ability of proton therapy, which is particularly beneficial for head and neck cancers. ^{1 2 3 4 5}

Is proton therapy safe for treating head and neck cancer?

Proton therapy, including intensity-modulated proton therapy (IMPT), has been shown to reduce the exposure of healthy organs to radiation compared to traditional methods, which can lead to fewer side effects like reduced feeding tube dependency. While more studies are needed, initial experiences suggest it is generally safe for treating head and neck cancers. ^{1 3 4 5 6}

How is proton therapy different from other treatments for recurrent head and neck cancer?

Proton therapy, specifically intensity-modulated proton therapy (IMPT), is unique because it precisely targets tumors while minimizing damage to surrounding healthy tissues, which can reduce side effects compared to traditional radiation therapies. This is particularly beneficial for head and neck cancers, where critical structures are closely located, and it may lead to better quality of life by reducing complications like pain and difficulty swallowing. ^{1 2 3 7 8}

What is the purpose of this trial?

The purpose of this study is to evaluate the tumor control and the side effects of using proton therapy for head and neck cancer that has come back.

Research Team

Nancy Lee, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for adults over 18 with recurrent or new primary head and neck cancer, previously treated with radiation. It's not suitable for pregnant women, those unable to follow the study procedures, or patients who finished prior radiation less than 6 months ago.

Inclusion Criteria

I am willing and able to sign a consent form.

I have received radiation treatment to my head or neck area.

I agree to use effective birth control during and for 3 months after treatment.

Exclusion Criteria

I am not pregnant or breastfeeding.

It's been less than 6 months since my last radiation therapy.

Inability to comply with study and/or follow-up procedures

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive proton therapy for recurrent head and neck cancer

6-8 weeks

Follow-up

Participants are monitored for locoregional recurrence and side effects after treatment

12 months

Treatment Details

Interventions

• Conventionally Fractionated Full Dose Re-irradiation
• Hypofractionated Palliative Re-irradiation
• Proton Therapy

Trial Overview The study tests proton therapy as a treatment for recurring head and neck cancer. Patients will receive either full dose re-irradiation if they have more than 6 months life expectancy or palliative care if less.

Participant Groups

Group I: hypofractionated palliative re-irradiation Experimental Treatment 1 Intervention

Group II: fractionated full dose re-irradiation Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

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]

In a study involving 7 patients with head and neck carcinomas, intensity-modulated proton therapy (IMPT) showed a smaller mean body dose compared to helical tomotherapy (HT), indicating potential benefits in reducing overall radiation exposure.

While HT provided steeper dose gradients and more conformal high dose regions, IMPT demonstrated better normal tissue sparing for specific organs at risk, suggesting that both treatment methods should be considered based on individual patient needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Re-irradiation of recurrent head and neck carcinomas: comparison of robust intensity modulated proton therapy treatment plans with helical tomotherapy. Stuschke, M., Kaiser, A., Abu-Jawad, J., et al.[2021]

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) 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) 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]

In a study of 47 patients with inoperable skin cancers of the head and neck treated with intensity-modulated proton therapy (IMPT), the overall survival rate at 2 years was high at 87.2%, indicating strong efficacy of this treatment.

IMPT demonstrated a low incidence of adverse events, with no patients experiencing severe side effects (grade 3 or higher) during or shortly after treatment, suggesting it is a safe option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oncologic Outcomes for Head and Neck Skin Malignancies Treated with Protons. Bridhikitti, J., Viehman, JK., Harmsen, WS., 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]

References

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

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

2. England pubmed.ncbi.nlm.nih.gov

Re-irradiation of recurrent head and neck carcinomas: comparison of robust intensity modulated proton therapy treatment plans with helical tomotherapy. [2021]

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

Multifield optimization intensity modulated proton therapy for head and neck tumors: a translation to practice. [2022]

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. 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]

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

Oncologic Outcomes for Head and Neck Skin Malignancies Treated with Protons. [2022]

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

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