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Photon Therapy

Proton vs Photon Radiotherapy for Head and Neck Cancer

Q: Are recruitment efforts for this trial ongoing at this time?

Yes, this trial is recruiting patients right now. The study was first posted on October 3, 2016 and was last edited on November 2, 2020.

Q: Are there hospitals in more than one country running this trial?

This study is taking place at 10 clinical sites, which are situated in Commack, Basking Ridge and Middletown, as well as 10 other cities. To limit travel, it is advised that patients choose the study site closest to their home.

Q: Does Proton beam radiotherapy (PBRT) pose any serious risks to patients?

Proton beam radiotherapy (PBRT) is a new medical treatment, so there is not yet any data supporting its efficacy. However, it has received a safety score of 2.

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

number of patients with grade 2 or greater acute mucositis

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

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,936 Previous Clinical Trials

588,790 Total Patients Enrolled

Mayo ClinicOTHER

3,212 Previous Clinical Trials

3,766,930 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

Frequently Asked Questions

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

Are recruitment efforts for this trial ongoing at this time?

"Yes, this trial is recruiting patients right now. The study was first posted on October 3, 2016 and was last edited on November 2, 2020."

Answered by AI

Are there hospitals in more than one country running this trial?

"This study is taking place at 10 clinical sites, which are situated in Commack, Basking Ridge and Middletown, as well as 10 other cities. To limit travel, it is advised that patients choose the study site closest to their home."

Answered by AI

Does Proton beam radiotherapy (PBRT) pose any serious risks to patients?

"Proton beam radiotherapy (PBRT) is a new medical treatment, so there is not yet any data supporting its efficacy. However, it has received a safety score of 2."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Proton Versus Photon Beam Radiotherapy in the Treatment of Head and Neck Cancer

2016. "Study of Proton Versus Photon Beam Radiotherapy in the Treatment of Head and Neck Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02923570.