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

PHASE2CompletedINTERVENTIONAL
Enrollment

3

Participants

Timeline

Start Date

September 1, 2017

Primary Completion Date

January 13, 2023

Study Completion Date

January 13, 2023

Conditions
Paranasal Sinus CancerNasal Cavity TumorNasal Cavity Adenocarcinoma
Interventions
DRUG

Cisplatin

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)

RADIATION

Adjuvant Proton Radiotherapy

"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."

PROCEDURE

Endoscopic Resection

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.

DRUG

cisplatin and etoposide

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.

Trial Locations (5)

10021

Memorial Sloan Kettering Cancer Center, New York

10604

Memoral Sloan Kettering Westchester, Harrison

07920

Memoral Sloan Kettering Basking Ridge, Basking Ridge

07748

Memoral Sloan Kettering Monmouth, Middletown

07645

Memorial Sloan Kettering Bergen, Montvale

All Listed Sponsors
lead

Memorial Sloan Kettering Cancer Center

OTHER

NCT03274414 - A Clinical Trial of Endoscopic Surgery Followed by Chemotherapy and Proton Radiation for the Treatment of Tumors in the Sinus and Nasal Passages | Biotech Hunter | Biotech Hunter