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Radiation Therapy

IMRT vs Proton Radiation Therapy for Sinonasal Cancer

N/A
Waitlist Available
Led By Annie W Chan, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with biopsy proven locally advanced sinus, nasal cavity, hard palate, soft palate, major or minor salivary gland tumors, or lacrimal apparatus, with nasal cavity, sinus, auditory canal, or skull base involvement are eligible.
Eastern cooperative oncology group (ECOG) performance status 0 - 1 or Karnofsky Performance Status ≥ 70.
Must not have
History of allergic reactions attributed to compounds of similar chemical or biologic composition to cisplatin for subjects who will receive chemotherapy
Previous irradiation for head and neck tumor, skull base, or brain tumors
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will test whether IMRT or proton radiation therapy improves local control rates and lowers toxicity compared to conventional radiation therapy in the treatment of locally advanced sinonasal malignancy.

Who is the study for?
This trial is for patients with advanced sinonasal cancers, including various carcinoma types and melanoma. Participants must have a good performance status, meaning they can carry out daily activities with little or no assistance. They should also have normal organ function and no history of allergic reactions to similar chemotherapy drugs if receiving chemotherapy.
What is being tested?
The study compares intensity-modulated radiotherapy (IMRT) and proton radiation therapy to see which one is better at controlling cancer growth while causing fewer side effects in treating advanced sinonasal malignancy. It's the first prospective study of its kind on these treatments.
What are the potential side effects?
Potential side effects from IMRT or proton radiation therapy may include skin redness, sore throat, dry mouth, fatigue, nausea, and difficulty swallowing. 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
Select...
I have a confirmed advanced tumor in my sinus, nasal area, or related structures.
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I am fully active or able to carry out light work.
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My cancer is one of the listed types and is at an advanced stage or has spread to my skull or brain.
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I have had recent scans and exams to assess my cancer before joining the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am allergic to medications similar to cisplatin.
Select...
I have had radiation therapy for a tumor in my head, neck, skull base, or brain.
Select...
My cancer has spread to distant parts of my body.
Select...
I do not have any uncontrolled illnesses.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Local Control Rates
Secondary study objectives
Local control
Neurocognitive function
Patterns of Tumor Relapse
+4 more

Awards & Highlights

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

Trial Design

2Treatment groups
Active Control
Group I: Proton beam therapyActive Control1 Intervention
Subjects treated at Massachusetts General Hospital with proton beam therapy
Group II: IMRTActive Control1 Intervention
Intensity-modulated radiation therapy at institutions other than Massachusetts General Hospital

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
3,013 Previous Clinical Trials
13,309,266 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,812 Previous Clinical Trials
8,161,426 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,924 Previous Clinical Trials
41,017,906 Total Patients Enrolled

Media Library

Intensity-modulated radiotherapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01586767 — N/A
Adenoid Cystic Carcinoma Research Study Groups: Proton beam therapy, IMRT
Adenoid Cystic Carcinoma Clinical Trial 2023: Intensity-modulated radiotherapy Highlights & Side Effects. Trial Name: NCT01586767 — N/A
Intensity-modulated radiotherapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01586767 — N/A
~3 spots leftby Nov 2025
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