87 Participants Needed

Proton Therapy for Recurrent Head and Neck Cancer

Recruiting at 11 trial locations
OC
NL
HX
Overseen ByHan Xiao, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Memorial Sloan Kettering Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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.12345

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.13456

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.12378

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 Y. Lee, MD, FASTRO - MSK ...

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.
See 2 more

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
2Treatment groups
Experimental Treatment
Group I: hypofractionated palliative re-irradiationExperimental Treatment1 Intervention
Group II: fractionated full dose re-irradiationExperimental Treatment1 Intervention

Find a Clinic Near You

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

References

Intensity modulated proton therapy (IMPT) - The future of IMRT for head and neck cancer. [2020]
Re-irradiation of recurrent head and neck carcinomas: comparison of robust intensity modulated proton therapy treatment plans with helical tomotherapy. [2021]
Proton radiation therapy for head and neck cancer. [2018]
Multifield optimization intensity modulated proton therapy for head and neck tumors: a translation to practice. [2022]
Intensity-modulated proton beam therapy (IMPT) versus intensity-modulated photon therapy (IMRT) for patients with oropharynx cancer - A case matched analysis. [2022]
Reduced acute toxicity and improved efficacy from intensity-modulated proton therapy (IMPT) for the management of head and neck cancer. [2017]
Oncologic Outcomes for Head and Neck Skin Malignancies Treated with Protons. [2022]
Proton Therapy for HPV-Associated Oropharyngeal Cancers of the Head and Neck: a De-Intensification Strategy. [2022]
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