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Radiation Therapy
Radiotherapy Techniques for Sinonasal Malignancy
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. (Appendix B)
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up5 years
Awards & highlights
No Placebo-Only Group
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.
Eligible Conditions
- Adenoid Cystic Carcinoma
- Squamous Cell Carcinoma
- Sinonasal Cancer
- Sinonasal Carcinoma
- Mucoepidermoid Carcinoma
- Schneiderian Carcinoma
- Myoepithelial Carcinoma
- Esthesioneuroblastoma
- Melanoma
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You have been diagnosed with specific types of tumors in certain areas of the head and neck.
Select...
You are able to perform daily activities without any major limitations or only have minor limitations due to your health condition.
Select...
Your organs and bone marrow are working normally.
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You have been diagnosed with specific types of cancer in the nasal and sinus area, as well as certain types of advanced stage tumors. The diagnosis must be confirmed by your treating hospital.
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 moreAwards & 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
2,862 Previous Clinical Trials
13,149,019 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,636 Previous Clinical Trials
6,670,975 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,486 Previous Clinical Trials
41,265,892 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently addicted to alcohol.You are taking any other experimental medications for a different study.You have had allergic reactions to drugs similar to cisplatin, which is a type of chemotherapy.There is evidence that the cancer has spread to other parts of the body or to the covering of the brain and spinal cord.You have had radiation treatment for tumors in your head, neck, skull base, or brain before.You have had another type of cancer, but it has been treated and you have been cancer-free for at least 2 years. Some specific types of early-stage cancers are allowed within the past 2 years, such as certain types of skin, breast, or cervical cancers.You have been diagnosed with specific types of tumors in certain areas of the head and neck.You are able to perform daily activities without any major limitations or only have minor limitations due to your health condition.Your organs and bone marrow are working normally.You have been diagnosed with specific types of cancer in the nasal and sinus area, as well as certain types of advanced stage tumors. The diagnosis must be confirmed by your treating hospital.
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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