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

Memorial Sloan Kettering Cancer Center5 sites in 1 country3 target enrollmentSeptember 1, 2017

ConditionsParanasal Sinus Cancer Nasal Cavity Tumor Nasal Cavity Adenocarcinoma

InterventionsCisplatin Adjuvant Proton Radiotherapy Endoscopic Resection cisplatin and etoposide

DrugsCisplatin cisplatin and etoposide

Overview

Phase: Phase 2
Intervention: Cisplatin
Conditions: Paranasal Sinus Cancer
Sponsor: Memorial Sloan Kettering Cancer Center
Enrollment: 3
Locations: 5
Primary Endpoint: Local Control Assessment of Unresectable Paranasal Sinus and Nasal Cavity Tumors
Status: Completed
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 1, 2017

End Date

January 13, 2023

Last Updated

11 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Memorial Sloan Kettering Cancer Center

Responsible Party

Sponsor

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

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.

Arms & Interventions

Unresectable paranasal sinus/nasal cavity malignancy

Intervention: Cisplatin

Unresectable paranasal sinus/nasal cavity malignancy

Intervention: Adjuvant Proton Radiotherapy

Unresectable paranasal sinus/nasal cavity malignancy

Intervention: Endoscopic Resection

Unresectable paranasal sinus/nasal cavity malignancy

Intervention: cisplatin and etoposide

Outcomes

Primary Outcomes

Local Control Assessment of Unresectable Paranasal Sinus and Nasal Cavity Tumors

Time Frame: 1 year

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.