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Proton Beam Therapy

Proton Therapy for Head and Neck Cancer

Phase 2
Recruiting
Led By Scott C Lester
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Primary lesion located in the nasal cavity, paranasal sinuses, oral cavity, oropharynx, larynx, hypopharynx, salivary glands, lymph nodes (unknown primary or metastasis from head and neck [HN]-skin primary) or skin cancer where lymph node radiation is recommended
NOTE: Patients with primary lesions in the larynx must have a T3 primary, bulky T2 primary (> 6 cc), and/or at least 1 regional lymph node
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years
Awards & highlights

Study Summary

This trial is testing whether proton therapy can shrink tumors in patients with head and neck cancer.

Who is the study for?
Adults with non-HPV head and neck cancers, including oral, paranasal sinus, salivary gland, skin cancer, etc., who have good blood counts and organ function. They must be COVID-19 negative or recovered and not immunocompromised (except stable HIV). Pregnant women and those with recent heart issues or other active cancers are excluded.Check my eligibility
What is being tested?
The trial is testing intensity-modulated proton therapy as a post-surgery treatment to reduce tumor size in patients with various types of head and neck cancer. It includes cisplatin chemotherapy alongside radiation therapy using high-energy protons.See study design
What are the potential side effects?
Potential side effects may include skin reactions at the treatment site, dry mouth or throat due to radiation damage to salivary glands, nausea from chemotherapy, fatigue from both treatments, and possible low blood cell counts leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is in my head or neck area, including the mouth and throat.
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My larynx cancer is at an advanced stage or has spread to my lymph nodes.
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I have tested negative for COVID-19 or have been symptom-free for 14 days after a positive test. My vaccination status is documented.
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I was fully active or had some restrictions before starting treatment.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of local/regional control (LRF)
Secondary outcome measures
Distant recurrence rates
Incidence of acute adverse events
Incidence of late adverse events
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm B (IMPT, cisplatin)Experimental Treatment8 Interventions
Patients undergo surgical resection and then IMPT for 15 sessions (Monday-Friday) over 19 days in the absence of disease progression or unacceptable toxicity. Patients may receive cisplatin IV over 1-2 hours per standard of care.
Group II: Arm A (IMPT, cisplatin)Experimental Treatment8 Interventions
Patients who already underwent surgical resection undergo IMPT for 18 sessions (Monday-Friday) over 24 days in the absence of disease progression or unacceptable toxicity. Patients may receive cisplatin IV over 1-2 hours per standard of care.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~2720
Biospecimen Collection
2004
Completed Phase 2
~1730
Positron Emission Tomography
2008
Completed Phase 2
~2240
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Cisplatin
2013
Completed Phase 3
~1940
Intensity-Modulated Proton Therapy
2019
N/A
~10

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,550 Total Patients Enrolled
Mayo ClinicLead Sponsor
3,206 Previous Clinical Trials
3,766,966 Total Patients Enrolled
Scott C LesterPrincipal InvestigatorMayo Clinic in Rochester

Media Library

Intensity-Modulated Proton Therapy (Proton Beam Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05075980 — Phase 2
Head and Neck Cancers Research Study Groups: Arm A (IMPT, cisplatin), Arm B (IMPT, cisplatin)
Head and Neck Cancers Clinical Trial 2023: Intensity-Modulated Proton Therapy Highlights & Side Effects. Trial Name: NCT05075980 — Phase 2
Intensity-Modulated Proton Therapy (Proton Beam Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05075980 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are we currently enrolling people for this research project?

"Yes, this information can be found on clinicaltrials.gov. The trial was first advertised on February 21st 2021 and the most recent update was April 6th 2022."

Answered by AI

Are there other examples in the medical literature of Cisplatin being used in treatment?

"City of Hope Comprehensive Cancer Center first studied cisplatin in 1997 and, as of now, 1198 trials have been completed while 773 are ongoing. A considerable number of these active studies are based in Rochester, Minnesota."

Answered by AI

What is the primary purpose that Cisplatin is prescribed?

"Cisplatin is used to treat neoplasm metastasis and other conditions like advanced ovarian cancer. It may be employed when standard therapies have failed or in advance directives."

Answered by AI

What is the projected sample size for this experiment?

"Yes, this study is open for recruitment and the clinicaltrials.gov website has the most recent information. The trial was first posted on February 21st, 2021 and was edited April 6th, 2022. There are plans to enroll 117 patients at 2 sites."

Answered by AI

Does the FDA sanction use of Cisplatin?

"Cisplatin received a score of 2 from our team because while there is some data suggesting it is safe, none of the available information points to this medication being effective."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
HEADLIGHT: Hypofractionated Proton Therapy for Head and Neck Cancers
2022. "HEADLIGHT: Hypofractionated Proton Therapy for Head and Neck Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05075980.
~48 spots leftby Nov 2025
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