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

Phase 2

Completed

• Conditions: Paranasal Sinus Cancer; Nasal Cavity Tumor; Nasal Cavity Adenocarcinoma
• Interventions: Drug: Cisplatin; Radiation: Adjuvant Proton Radiotherapy; Procedure: Endoscopic Resection; Drug: cisplatin and etoposide

• Registration Number: NCT03274414
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-01
• Study First Submitted: 2017-09-05
• Study First Submitted QC: 2017-09-05
• Study First Posted: 2017-09-07
• Status Verified: 2023-01
• Primary Completion: 2023-01-13
• Study Completion: 2023-01-13
• Results First Submitted: 2023-09-22
• Results First Submitted QC: 2023-09-22
• Last Update Submitted: 2023-09-22
• Results First Posted: 2023-10-18
• Last Update Posted: 2023-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

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. For patients who have had surgery at an outside institution, the same parameters will be thoroughly screened to ensure the patient met the same inclusion criteria and resection standards.

• 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.

• Patients who intitially meet the histopathological inclusion criteria but surgical pathology report shows Sinonasal Undifferentiated Carcinoma.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Unresectable paranasal sinus/nasal cavity malignancy	Cisplatin	-
Unresectable paranasal sinus/nasal cavity malignancy	Adjuvant Proton Radiotherapy	-
Unresectable paranasal sinus/nasal cavity malignancy	Endoscopic Resection	-
Unresectable paranasal sinus/nasal cavity malignancy	cisplatin and etoposide	-

Primary Outcome Measures

Name	Time	Method
Local Control Assessment of Unresectable Paranasal Sinus and Nasal Cavity Tumors	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.

Trial Locations

Locations (5)

Memorial Sloan Kettering Bergen; 🇺🇸 Montvale, New Jersey, United States

Memoral Sloan Kettering Westchester; 🇺🇸 Harrison, New York, United States

Memoral Sloan Kettering Basking Ridge; 🇺🇸 Basking Ridge, New Jersey, United States

Memoral Sloan Kettering Monmouth; 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States