Clinical Trials /

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

NCT03274414

Description:

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.

Related Conditions:
  • Adenoid Cystic Carcinoma
  • Nasal Cavity Adenocarcinoma
  • Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma
  • Olfactory Neuroblastoma
  • Paranasal Sinus Adenocarcinoma
  • Sinonasal Undifferentiated Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: 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

Clinical Trial IDs

  • ORG STUDY ID: 17-442
  • NCT ID: NCT03274414

Conditions

  • Paranasal Sinus Cancer
  • Nasal Cavity Tumor
  • Nasal Cavity Adenocarcinoma

Interventions

DrugSynonymsArms
CisplatinUnresectable paranasal sinus/nasal cavity malignancy
cisplatin and etoposideUnresectable paranasal sinus/nasal cavity malignancy

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Unresectable paranasal sinus/nasal cavity malignancyExperimental
  • Cisplatin
  • cisplatin and etoposide

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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Local control assessment of unresectable paranasal sinus and nasal cavity tumors
Time Frame:1 year
Safety Issue:
Description:Assessment of local control after near-total endoscopic resection (NTR) followed by concurrent chemotherapy with proton-beam radiation in unresectable tumors (which we define as expected inability to perform negative margin surgery) of the paranasal sinuses and nasal cavity.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Memorial Sloan Kettering Cancer Center

Trial Keywords

  • squamous cell carcinoma
  • esthesioneuroblastoma
  • adenoid cystic carcinoma
  • adenocarcinoma
  • cisplatin
  • 17-442

Last Updated

May 20, 2020