A Clinical Trial of Endoscopic Surgery Followed by Chemotherapy and Proton Radiation for the Treatment of Tumors in the Sinus and Nasal Passages
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03274414|
Recruitment Status : Active, not recruiting
First Posted : September 7, 2017
Last Update Posted : July 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Paranasal Sinus Cancer Nasal Cavity Tumor Nasal Cavity Adenocarcinoma||Drug: Cisplatin Radiation: Adjuvant Proton Radiotherapy Procedure: Endoscopic Resection Drug: cisplatin and etoposide||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||September 1, 2017|
|Estimated Primary Completion Date :||September 1, 2021|
|Estimated Study Completion Date :||September 1, 2021|
|Experimental: Unresectable paranasal sinus/nasal cavity malignancy||
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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03274414
|United States, New Jersey|
|Memoral Sloan Kettering Basking Ridge|
|Basking Ridge, New Jersey, United States, 07920|
|Memoral Sloan Kettering Monmouth|
|Middletown, New Jersey, United States, 07748|
|Memorial Sloan Kettering Bergen|
|Montvale, New Jersey, United States, 07645|
|United States, New York|
|Memoral Sloan Kettering Westchester|
|Harrison, New York, United States, 10604|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10021|
|Principal Investigator:||Marc Cohen, MD||Memorial Sloan Kettering Cancer Center|