A Clinical Trial of Endoscopic Surgery Followed by Chemotherapy and Proton Radiation for the Treatment of Tumors in the Sinus and Nasal Passages



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:1/30/2019
Start Date:September 1, 2017
End Date:September 1, 2020
Contact:Marc Cohen, MD
Email:cohenm2@mskcc.org
Phone:212-639-3769

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A Phase II, Single-Arm Trial Assessing Local Control of Near Total Endoscopic Resection Followed by Concurrent Chemotherapy and Proton Radiation in the Treatment of Unresectable Sinonasal Tumors

This study is being done to test a new treatment plan for large tumors in the sinus or nasal
cavity that will include endoscopic surgery plus chemotherapy and proton-beam radiation
therapy.


Inclusion Criteria:

- Age greater than or equal to 18 years.

- Histopathologically confirmed diagnosis of one the following cancer types:

- Squamous cell carcinoma

- Esthesioneuroblastoma

- Adenoid cystic carcinoma

- Adenocarcinoma

- Paranasal sinus/nasal cavity malignancy is considered unresectable with negative
margins surgery or resection would be considered excessively morbid. This could
include lesions with:

- Carotid involvement

- Cavernous sinus invasion

- Brain invasion

- Orbital apex

- Intraconal space

- Pterygoid musculature involvement

- Invasion of the clivus

- Resection of at least 80% of the volume of the tumor is feasible. Resectability will
be determined by the surgeon and radiologist after discussion among the
multidisciplinary team.

- Patients must be a candidate for surgery (as per treating surgeon) and be able to
tolerate proton radiation and chemotherapy (as per treating radiation oncologist and
medical oncologist).

- Karnofsky performance statue >/= 70

- The subject has organ and marrow function and laboratory values rendering safe
administration of Cisplatin:

- The ANC >/= 1000/mm3 without colony stimulating factor support

- Platelets >/= 100,000/mm3

- Hemoglobin >/= 9 g/dL

- Bilirubin
- Serum albumin >/= 2.8 g/dl

- Creatinine clearance (CrCl) >/= 60 mL/min. For creatinine clearance estimation,
the Cockcroft and Gault equation should be used:

- Male: CrCl (mL/min) = (140 = age) x wt (kg) / (serum creatinine x 72)

- Female: Multiply above result by 0.85

- ALT and AST
- Serum phosphorus, calcium, magnesium and potassium >/= LLN

- No evidence of intercurrent infection

- Negative pregnancy test for women of childbearing potential (<51 years of age) as per
institutional policy.

- Patients with distant metastatic disease may not be included.

- Patient must be able to read and write in English.

- Patients who intitially meet the histopathological inclusion criteria but surgical
pathology report shows Sinonasal Undifferentiated Carcinoma.

Exclusion Criteria:

- Tumor is deemed to be resectable with negative margins by conventional surgical
standards.

- Patients not able to receive standard-dose cisplatin based on the judgement of the
treating medical oncologist.

- Patients with chronic kidney disease (GFR <60), uncontrolled hypertension, congestive
heart failure, pre-existing bone marrow dysfunction, or cytopenias.

° Congestive heart failure (CHF): New York Heart Association (NYHA) Class II-IV at the
time of screening

- Concurrent uncontrolled hypertension defined as sustained blood pressure > 150 mm Hg
systolic or > 100 mm Hg diastolic despite optimal antihypertensive treatment within 7
days of the first dose of study treatment; If severe hearing impairment is measured or
if significant neuropathy is reported at baseline the treating physician will discuss
the risks for further permanent hearing loss and neuropathy with the patient.

- Patients not able to have a MRI (due to pacemaker, claustrophobia, etc.).

- Inability to return to MSKCC for frequent scheduled hydration sessions
post-chemotherapy.

- Inability to comply with requirements for cisplatin administration anti-emetic
regimens post-treatment.

- Patients not able or unwilling to travel for proton therapy.
We found this trial at
5
sites
136 Mountainview Boulevard
Basking Ridge, New Jersey 07920
Phone: 212-639-3769
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Harrison, New York
Phone: 212-639-3769
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480 Red Hill Road
Middletown, New Jersey 07748
Phone: 212-639-3769
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225 Summit Avenue
Montvale, New Jersey 07645
Phone: 212-639-3769
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1275 York Ave
New York, New York 10021
(212) 639-2000
Phone: 212-639-3769
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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