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Proton Therapy for Recurrent Head and Neck Cancer

Phase 2
Waitlist Available
Led By Nancy Lee, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥18 years at the time of consent
A history of prior radiation to the head and neck (≥ 40 Gy, in 2 Gy/fraction equivalent)
Must not have
Women who are pregnant or lactating
<6 months between completion of prior RT and initiation of reirradiation using proton therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial tests proton therapy as a cancer treatment for head and neck cancer patients whose cancer has returned. They will measure tumor control and side effects.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects of proton therapy may include skin reactions, fatigue, dry mouth, difficulty swallowing, and changes in taste. The severity can vary based on individual patient factors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have received radiation treatment to my head or neck area.
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My cancer in the head or neck area has come back or is a new one.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant or breastfeeding.
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It's been less than 6 months since my last radiation therapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
locoregional recurrence-free

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,969 Previous Clinical Trials
597,325 Total Patients Enrolled
Nancy Lee, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
16 Previous Clinical Trials
2,418 Total Patients Enrolled
~6 spots leftby Jul 2025
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