A Phase II Study of Intensity-Modulated or Proton Radiation Therapy for Locally Advanced Sinonasal Malignancy
18 Years
N/A
Both
Adenoid Cystic Carcinoma, Squamous Cell Carcinoma, Sinonasal Carcinoma, Sinonasal Undifferentiated Carcinoma
Trial Information
A Phase II Study of Intensity-Modulated or Proton Radiation Therapy for Locally Advanced Sinonasal Malignancy
Subjects will receive daily proton radiation treatment as outpatients at the Francis H. Burr
Proton Center at Massachusetts General Hospital. The subjects may also receive concurrent
standard chemotherapy every week during their radiation therapy. This chemotherapy is
considered standard treatment for their cancer and is not being done for research purposes.
In addition to daily radiation treatments, subjects will have the following tests every
week: review of side effects; physical exam, including weight, height, neurological exam and
vital signs; and blood tests, only for those subjects also receiving chemotherapy.
Subjects will be followed for 5 years after the completion of study treatment. The first
follow-up visit will be 6-8 weeks after completion of study treatment. Additional follow-up
visits will be performed every 3 months during the first 2 years following completion of
radiation then every 6 month during years 3-5. At each follow-up visit, subjects will
receive a physical exam, chest CT scan (at 1st follow-up visit then at least every 6
months), a CT or MRI tumor assessment (at 1st follow-up visit then at least every 6 months),
quality-of-life questionnaire, hearing test, neuro-ophthalmology test, and neurocognitive
test.
Inclusion Criteria:
- Biopsy proven of sinonasal adenoid cystic carcinoma or squamous cell carcinoma within
12 weeks prior to study entry
- Nutritional and general physical condition must be considered compatible with the
proposed radiation +/- chemotherapy treatment
- Normal organ and marrow function
Exclusion Criteria:
- Active alcohol addiction
- Pregnant or breastfeeding
- Receiving any other study agents
- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to cisplatin for subjects who will receive chemotherapy
- Evidence of distant metastases or distant leptomeningeal metastases
- Previous irradiation for head and neck tumor, skull base, or brain tumors
- Uncontrolled intercurrent illness
- History of a different malignancy unless disease-free for at least 2 years and are
deemed by the investigator to be at low-risk for recurrence. Individuals with the
following cancers are eligible if diagnosed and treated for cure within the past 2
years: cervical cancer in situ, carcinoma in situ of the breast, and basal cell or
squamous ceel carcinoma of the skin
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Local Control Rates
Outcome Description:
To determine the local control rates with IMRT or proton radiation therapy at 2 years.
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Annie W Chan, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Massachusetts General Hospital
Authority:
United States: Institutional Review Board
Study ID:
10-308
NCT ID:
NCT01586767
Start Date:
July 2011
Completion Date:
July 2016
Related Keywords:
- Adenoid Cystic Carcinoma
- Squamous Cell Carcinoma
- Sinonasal Carcinoma
- Sinonasal Undifferentiated Carcinoma
- Nasal cavity
- Salivary gland tumors
- Hard palate
- Carcinoma
- Carcinoma, Squamous Cell
- Carcinoma, Adenoid Cystic
- Maxillary Sinus Neoplasms
Name | Location |
|---|---|
| Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
