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

NCT03274414 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 17-442
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 5

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.

Conditions

Paranasal Sinus Cancer; Nasal Cavity Tumor; Nasal Cavity Adenocarcinoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Local Control Assessment of Unresectable Paranasal Sinus and Nasal Cavity Tumors

  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.

  1 year

Study Arms (1)

Unresectable paranasal sinus/nasal cavity malignancy

EXPERIMENTAL

Drug: Cisplatin; Radiation: Adjuvant Proton Radiotherapy; Procedure: Endoscopic Resection; Drug: cisplatin and etoposide

Interventions

Cisplatin DRUG

Cisplatin should be administered on day 1 (+/- 3 days) of the start of radiotherapy and then every 3 weeks (unless there is a delay for safety concerns such as neutropenia) for a total of 3 cycles. 100 mg/m\^2 (dose reductions after the first cycle allowed for toxicity)

Unresectable paranasal sinus/nasal cavity malignancy

Adjuvant Proton Radiotherapy RADIATION

Proton therapy treatment will follow the National Cancer Institute's "Guidelines for the Use of Proton Radiation Therapy in NCI-Sponsored Cooperative Group Trials". Proton therapy techniques may include passively scattered or scanning or pencil beam technology.

Unresectable paranasal sinus/nasal cavity malignancy

Endoscopic Resection PROCEDURE

In brief, an endoscope is used and two surgeons perform the intervention in a binostril manner. Tumor is generally resected with an emphasis on identification of the attachments in the paranasal sinuses, nasal cavity, or skull base.

Unresectable paranasal sinus/nasal cavity malignancy

cisplatin and etoposide DRUG

If the final surgical pathology report shows SNUC, at the discretion of the treating medical oncologist, the patient will receive an addition of etoposide chemotherapy to cisplatin chemotherapy. The dose of cisplatin will be decresed from 100 mg/m2 to 60 mg/m2. Cisplatin should be administered on days 1-2, 21-22 and 42-43 at a dose of 60 mg/m2 and Etoposide should be administered at days 1-3, 21-23, and 42-44 at a dose of 120 mg/m2.

Unresectable paranasal sinus/nasal cavity malignancy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (5)

Memoral Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

Memoral Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen

Montvale, New Jersey, 07645, United States

Location

Memoral Sloan Kettering Westchester

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10021, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Paranasal Sinus Neoplasms; Carcinoma, Squamous Cell; Esthesioneuroblastoma, Olfactory; Carcinoma, Adenoid Cystic; Adenocarcinoma

Interventions

Cisplatin; Endoscopic Mucosal Resection; Etoposide

Condition Hierarchy (Ancestors)

Nose Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Nose Diseases; Respiratory Tract Diseases; Paranasal Sinus Diseases; Respiratory Tract Neoplasms; Otorhinolaryngologic Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell; Neuroblastoma; Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Olfactory Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Results Point of Contact

• Title: Dr. Marc Cohen, MD
• Organization: Memorial Sloan Kettering Cancer Center

cohenm2@mskcc.org

212-639-3769

Study Officials

• Marc Cohen, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2017
• First Posted: September 7, 2017
• Study Start: September 1, 2017
• Primary Completion: January 13, 2023
• Study Completion: January 13, 2023
• Last Updated: May 16, 2025
• Results First Posted: October 18, 2023

Record last verified: 2023-01

Locations

US (5)