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

This study is currently recruiting participants.
Verified December 2017 by Memorial Sloan Kettering Cancer Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT03274414
First Posted: September 7, 2017
Last Update Posted: December 8, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
  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.

Condition Intervention Phase
Paranasal Sinus Cancer Nasal Cavity Tumor Nasal Cavity Adenocarcinoma Drug: Cisplatin Radiation: Adjuvant Proton Radiotherapy Procedure: Endoscopic Resection Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Memorial Sloan Kettering Cancer Center:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 25
Actual Study Start Date: September 1, 2017
Estimated Study Completion Date: September 1, 2020
Estimated Primary Completion Date: September 1, 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Unresectable paranasal sinus/nasal cavity malignancy 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.

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  • 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.

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.
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Marc Cohen, MD 212-639-3769 cohenm2@mskcc.org
Contact: Sasan Karimi, MD 212-639-8633 karimis@mskcc.org

Locations
United States, New Jersey
Memoral Sloan Kettering Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Marc Cohen, MD    212-639-3769      
Memoral Sloan Kettering Monmouth Recruiting
Middletown, New Jersey, United States, 07748
Contact: Marc Cohen, MD    212-639-3769      
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Marc Cohen, MD    212-639-3769      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
Principal Investigator: Marc Cohen, MD Memorial Sloan Kettering Cancer Center
  More Information

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03274414     History of Changes
Other Study ID Numbers: 17-442
First Submitted: September 5, 2017
First Posted: September 7, 2017
Last Update Posted: December 8, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Memorial Sloan Kettering Cancer Center:
squamous cell carcinoma
esthesioneuroblastoma
adenoid cystic carcinoma
adenocarcinoma
cisplatin
17-442

Additional relevant MeSH terms:
Adenocarcinoma
Paranasal Sinus Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Nose Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nose Diseases
Respiratory Tract Diseases
Paranasal Sinus Diseases
Respiratory Tract Neoplasms
Otorhinolaryngologic Diseases
Cisplatin
Antineoplastic Agents