Proton Therapy for Recurrent Head and Neck Cancer

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness and safety of proton therapy for treating recurrent head and neck cancer. Proton therapy, a specialized form of radiation, aims to target tumors more precisely and reduce side effects. The study will test different delivery methods, including conventionally fractionated full-dose re-irradiation and hypofractionated palliative re-irradiation, to determine the most effective approach. It suits individuals who have had head and neck cancer, previously received radiation, and now have cancer that cannot be surgically removed. Participants capable of having children should use effective birth control during and after the trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to advancements in cancer care.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that proton therapy is a safer choice than traditional radiation treatments for head and neck cancers, as it causes fewer problems in healthy tissues. For instance, one study found that patients receiving proton therapy had similar success in controlling their tumors but experienced fewer side effects compared to those receiving other types of radiation. This suggests that proton therapy might be easier for patients to handle, reducing the risk of harmful side effects.

In another study, 242 patients with head and neck cancers who received proton therapy had a 71.8% success rate in controlling the cancer locally after one year. This indicates that proton therapy can effectively manage the cancer while being safe. Overall, research supports proton therapy as a promising and safer treatment option for recurring head and neck cancers. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard of care for recurrent head and neck cancer, which often involves conventional radiation therapy, proton therapy offers a unique advantage by delivering high-dose radiation directly to the tumor with minimal damage to surrounding healthy tissues. Researchers are excited about this approach because it has the potential to reduce side effects and improve the quality of life for patients. Additionally, the precision of proton therapy may enhance treatment effectiveness, potentially leading to better outcomes compared to traditional methods. This innovative delivery method sets proton therapy apart as a promising option for those who have already undergone radiation treatment.

What evidence suggests that this trial's treatments could be effective for recurrent head and neck cancer?

Research has shown that proton therapy is a promising treatment for head and neck cancers, particularly when they recur. One study found that proton therapy effectively controlled tumors in 71.8% of patients one year after treatment, with 66.6% of these patients still alive at that time. Proton therapy causes fewer side effects to healthy tissues compared to traditional radiation treatments, making it a safer choice for sensitive areas like the head and neck. In this trial, participants may receive proton therapy as one of the treatment options. These findings suggest that proton therapy could be a strong option for managing recurring head and neck cancer. ^{1 2 3 6 7}

Who Is on the Research Team?

Nancy Lee, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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 have received radiation treatment to my head or neck area.

I am willing and able to sign a consent form.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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]

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]

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]

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 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]

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. tro.amegroups.org tro.amegroups.org/article/view/7610/html

A narrative review of intensity-modulated proton therapy for ... We aim to summarize and discuss the literature on intensity-modulated proton therapy (IMPT) in head and neck cancer and elucidate its benefits and limitations ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4997784/

Proton Beam Re-Irradiation for Recurrent Head and Neck ... Proton beam re-irradiation of the head and neck can provide effective tumor control with acceptable acute and late toxicity profiles.

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2800711

Proton Therapy Reirradiation for Patients With Recurrent ... This cohort study of 242 patients with HNSCC found 1-year local control of 71.8% and 1-year overall survival of 66.6% for those receiving fractionated ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0167814023898656

Comparing the oncologic outcomes of proton therapy and ... We studied HNSCC patients who underwent curative-intent RT from 2015 to 2019, comparing the oncologic outcomes of proton therapy and IMRT.

6. cancer.gov cancer.gov/news-events/cancer-currents-blog/2020/proton-therapy-safety-versus-traditional-radiation

Is Proton Therapy Safer than Traditional Radiation? - NCI A type of radiation treatment called proton beam radiation therapy may be safer and just as effective as traditional radiation therapy for adults with advanced ...

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/hed.27877

Efficacy and safety of proton therapy versus intensity‐ ... To comprehensively evaluate the therapeutic efficacy and safety when utilizing proton therapy (PT) versus intensity-modulated radiation ...