Intensity-Modulated or Proton Radiation Therapy for Sinonasal Malignancy
| Status: | Recruiting |
|---|---|
| Conditions: | Skin Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/23/2018 |
| Start Date: | July 2011 |
| End Date: | July 2024 |
| Contact: | Annie W Chan, MD |
| Email: | awchan@partners.org |
| Phone: | 617-724-1159 |
A Phase II Study of Intensity-Modulated or Proton Radiation Therapy for Locally Advanced Sinonasal Malignancy
The purpose of this study is to test the hypothesis that 1)intensity-modulated radiotherapy
(IMRT) or proton radiation therapy would result in improved local control rate and lowered
toxicity compared to conventional radiotherapy, and 2) proton radiation therapy would result
in equivalent or improved local control rate with similar or lower toxicity compared to IMRT,
in the treatment of locally advanced sinonasal malignancy.
Data from retrospective studies suggest that IMRT or proton radiation therapy resulted in
promising outcome in patients with sinonasal malignancy. To this date, no prospective study
has been conducted to evaluate the outcome of sinonasal cancer treated with IMRT or proton
radiation therapy. This Phase II trial is the first prospective study conducted to determine
the treatment outcome and toxicity of IMRT or proton in the treatment of sinonasal cancer.
IMRT and proton radiation therapy are the two most established and most commonly employed
advanced radiotherapy techniques for the treatment of sinonasal cancer. It is highly
controversial whether one is superior to the other in terms of local control and toxicity
outcome. It is also not clear if a subset of patients would benefit more from one treatment
technology versus the other.
Due to the rarity and heterogeneity of sinonasal malignancies and the fact that proton beam
is only available at a few centers in the United States, it is not feasible at present to do
a Phase III study randomizing patients between IMRT and proton radiation therapy. In this
study, a planned secondary analysis will be performed, comparing the treatment and toxicity
outcome between IMRT and proton. The data on the IMRT and proton comparison from this trial
will be used to design future multi-center prospective trials and to determine if randomized
trial is necessary.
In this study, the treatment technique employed for an individual case will not be determined
by the treating physician(s), but rather by the most advanced technology available at the
treating institution for the treatment of the sinonasal cancer. At the Massachusetts General
Hospital (MGH), proton beam therapy will be used for patients who meet the eligibility
criteria. For institutions where protons are not available or institutions where the proton
planning systems have not been optimized, IMRT exclusively will be used for the treatment of
sinonasal cancer. Patient and tumor characteristics are expected to be comparable between
IMRT- and proton- institutions
(IMRT) or proton radiation therapy would result in improved local control rate and lowered
toxicity compared to conventional radiotherapy, and 2) proton radiation therapy would result
in equivalent or improved local control rate with similar or lower toxicity compared to IMRT,
in the treatment of locally advanced sinonasal malignancy.
Data from retrospective studies suggest that IMRT or proton radiation therapy resulted in
promising outcome in patients with sinonasal malignancy. To this date, no prospective study
has been conducted to evaluate the outcome of sinonasal cancer treated with IMRT or proton
radiation therapy. This Phase II trial is the first prospective study conducted to determine
the treatment outcome and toxicity of IMRT or proton in the treatment of sinonasal cancer.
IMRT and proton radiation therapy are the two most established and most commonly employed
advanced radiotherapy techniques for the treatment of sinonasal cancer. It is highly
controversial whether one is superior to the other in terms of local control and toxicity
outcome. It is also not clear if a subset of patients would benefit more from one treatment
technology versus the other.
Due to the rarity and heterogeneity of sinonasal malignancies and the fact that proton beam
is only available at a few centers in the United States, it is not feasible at present to do
a Phase III study randomizing patients between IMRT and proton radiation therapy. In this
study, a planned secondary analysis will be performed, comparing the treatment and toxicity
outcome between IMRT and proton. The data on the IMRT and proton comparison from this trial
will be used to design future multi-center prospective trials and to determine if randomized
trial is necessary.
In this study, the treatment technique employed for an individual case will not be determined
by the treating physician(s), but rather by the most advanced technology available at the
treating institution for the treatment of the sinonasal cancer. At the Massachusetts General
Hospital (MGH), proton beam therapy will be used for patients who meet the eligibility
criteria. For institutions where protons are not available or institutions where the proton
planning systems have not been optimized, IMRT exclusively will be used for the treatment of
sinonasal cancer. Patient and tumor characteristics are expected to be comparable between
IMRT- and proton- institutions
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.
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, within 16 weeks prior to study entry, sinonasal adenoid cystic
carcinoma, adenocarcinoma, mucoepidermoid carcinoma, squamous cell carcinoma,
including sinonasal carcinoma, sinonasal undifferentiated carcinoma, Schneiderian
carcinoma, myoepithelial carcinoma, undifferentiated carcinoma, esthesioneuroblastoma,
or melanoma AJCC 7th edition Stage III - IVA/B tumors, or with skull base or
intracranial extension. Pathology must be confirmed by review at the treating
institution.
- 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)
- All patients must undergo pre-treatment evaluation of tumor extent prior to study
entry through imaging studies and clinical examinations, including CT and/or MRI of
skull base, brain and neck within 28 days prior to study entry; physical examination
+/- nasal endoscopy within 28 days prior to study entry; and CT of the chest within 60
days 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
We found this trial at
2
sites
185 Cambridge Street
Boston, Massachusetts 02114
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Annie W Chan, MD
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200 First Street SW
Rochester, Minnesota 55905
Rochester, Minnesota 55905
507-284-2511
Phone: 507-284-3551
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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