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Photon Therapy

Proton vs Photon Radiotherapy for Head and Neck Cancer

Phase 2
Recruiting
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
Histopathologically confirmed diagnosis of one the following cancer types: Salivary gland cancer, Skin cancer, Melanoma, HNSCC that require ipsilateral radiation
Negative pregnancy test for women of childbearing potential (<51 years of age) as per institutional policy.
Must not have
Non-resectable disease.
Any prior head or neck irradiation.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare the side effects of two different types of radiation therapy for head and neck cancer.

Who is the study for?
This trial is for adults over 18 with certain types of head and neck cancer, including salivary gland, skin cancer, melanoma, or HNSCC requiring one-sided radiation. Participants must be in good physical condition (Karnofsky score ≥70) and women able to have children must not be pregnant.
What is being tested?
The study compares two types of radiation therapy: Photon IMRT and Proton PBRT. It aims to determine if PBRT results in fewer side effects by reducing exposure to healthy tissues compared to the more traditional IMRT method.
What are the potential side effects?
Both IMRT and PBRT can cause skin redness, sore throat, dry mouth, taste changes, fatigue, difficulty swallowing. The trial seeks to find out if PBRT has fewer or similar side effects compared to IMRT.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with salivary gland cancer, skin cancer, melanoma, or head and neck cancer needing radiation on one side.
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I am a woman under 51 and have a negative pregnancy test.
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I am 18 years old or older.
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I am able to care for myself but may not be able to do active work.
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I am eligible for radiation therapy on the same side of my body as my tumor.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My condition cannot be treated with surgery.
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I have had radiation therapy to my head or neck.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
number of patients with grade 2 or greater acute mucositis

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: Proton beam radiotherapy (PBRT)Experimental Treatment1 Intervention
PBRT to standard dose of 60-66Gy
Group II: Photon intensity modulated radiation therapy (IMRT)Experimental Treatment1 Intervention
IMRT to standard dose of 60-66Gy

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,969 Previous Clinical Trials
597,215 Total Patients Enrolled
Mayo ClinicOTHER
3,333 Previous Clinical Trials
3,060,064 Total Patients Enrolled
Mount Sinai Hospital, New YorkOTHER
34 Previous Clinical Trials
891,490 Total Patients Enrolled

Media Library

Photon intensity modulated radiation therapy (IMRT) (Photon Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02923570 — Phase 2
Head and Neck Cancers Research Study Groups: Photon intensity modulated radiation therapy (IMRT), Proton beam radiotherapy (PBRT)
Head and Neck Cancers Clinical Trial 2023: Photon intensity modulated radiation therapy (IMRT) Highlights & Side Effects. Trial Name: NCT02923570 — Phase 2
Photon intensity modulated radiation therapy (IMRT) (Photon Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02923570 — Phase 2
~10 spots leftby Oct 2025
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