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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have a confirmed advanced tumor in my sinus, nasal area, or related structures.
Select...
I am fully active or able to carry out light work.
Select...
My cancer is one of the listed types and is at an advanced stage or has spread to my skull or brain.
Select...
I have had recent scans and exams to assess my cancer before joining the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Local Control Rates
Secondary outcome measures
Local control
Neurocognitive function
Patterns of Tumor Relapse
+4 moreTrial 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
2,928 Previous Clinical Trials
13,198,310 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,543 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,108 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My organs and bone marrow are functioning normally.I have a confirmed advanced tumor in my sinus, nasal area, or related structures.I am fully active or able to carry out light work.I am allergic to medications similar to cisplatin.I've been cancer-free for 2 years, except for certain skin, cervical, or breast cancers.I have had radiation therapy for a tumor in my head, neck, skull base, or brain.My cancer is one of the listed types and is at an advanced stage or has spread to my skull or brain.I have had recent scans and exams to assess my cancer before joining the study.My overall health supports undergoing radiation or chemotherapy.My cancer has spread to distant parts of my body.I do not have any uncontrolled illnesses.
Research Study Groups:
This trial has the following groups:- Group 1: Proton beam therapy
- Group 2: IMRT
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the size of the cohort involved in this research?
"Affirmative, the data hosted on clinicaltrials.gov documents that this medical trial is currently recruiting patients. Initially posted in July 2011 and most recently updated June 2021, the study requires 90 participants to be recruited between two sites."
Answered by AI
Is enrollment for this trial still available to interested participants?
"Per the clinicaltrials.gov website, this trial is actively looking for participants to enrol in it; having first been posted on July 1st 2011 and updated as recently as June 2nd 2021."
Answered by AI
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