Clinical trial NCT03274414: A Clinical Trial of Endoscopic Surgery Followed by Chemotherapy and Proton Radiation for the Treatment of Tumors in the Sinus and Nasal Passages
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Paranasal Sinus Cancer
Nasal Cavity Tumor
Nasal Cavity Adenocarcinoma
Keywords: squamous cell carcinoma
esthesioneuroblastoma
adenoid cystic carcinoma
adenocarcinoma
cisplatin
17-442
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2017-09-07
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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. For patients who have had surgery at an outside institution, the same parameters will be thoroughly screened to ensure the patient met the same inclusion criteria and resection standards.
* 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 \</= 1.5 mg/dL the ULM. For subjects with Gilbert's disease, bilirubin \</= 3.0 mg/dL
  * 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 \</= 3.0 ULN
  * 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.

Primary outcomes:
measure: Local Control Assessment of Unresectable Paranasal Sinus and Nasal Cavity Tumors
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memoral Sloan Kettering Basking Ridge
state: New Jersey
city: Middletown
country: United States
facility: Memoral Sloan Kettering Monmouth
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen
state: New Jersey
city: Harrison
country: United States
facility: Memoral Sloan Kettering Westchester
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Marc Cohen, MD
role: PRINCIPAL_INVESTIGATOR
References: