Chemoradiotherapy Followed by Surgery for Advanced Paranasal Sinus Cancer

Overview

The purpose of this study is to determine the efficacy of concurrent chemotherapy and radiotherapy pre-operatively in patients with advanced paranasal sinus cancer. The main objectives of this study are: 1) to measure the rate of complete response to preoperative chemoradiation and 2) to study the efficacy of combining preoperative chemoradiation and surgery in terms of local control of the cancer two years post treatment.

Full Title of Study: “Preoperative Radiotherapy and Concomitant Chemotherapy Followed by Surgery for Advanced Paranasal Sinus Carcinoma”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)

Interventions

  • Drug: cisplatin
  • Procedure: targeted radiation therapy
  • Procedure: tumor resection

Clinical Trial Outcome Measures

Primary Measures

  • Local control of cancer at two years post treatment
  • Response to preoperative chemoradiation

Secondary Measures

  • Estimation of the proportion of the inoperable tumors which become operable after chemoradiation
  • Identification of factors that are associated with inoperability
  • Estimation of the overall survival and cumulative incidence of death due to disease at 2 years
  • Determination of the acute and long-term toxicity, particularly ophthalmologic complications, and surgical morbidity associated with this regimen
  • Measurement of the accuracy of conventional imaging techniques (CT, MRI) compared with the addition of PET imaging in predicting the response to chemoradiation therapy.

Participating in This Clinical Trial

Inclusion Criteria

  • Karnofsky Performance Score: >= 60 – Creatinin clearance >= 50 ml/min or serum creatinine =<1.5 mg/dl – Total bilirubin, AST, ALT =< 1.5 X laboratory uln – ANC >= 2000/mm3, platelets >= 100,000/mm3 – Serum calcium within normal range – T3 or T4 state tumors of paranasal sinuses – Squamous cell carcinoma, adenocarcinoma, high-grade mucoepidermoid carcinoma, sinonasal undifferentiated carcinoma Exclusion Criteria:

  • History of other malignancy in the last 3 years – Other serious comorbidity that may significantly reduce the survival in next 5 years – Pregnant or lactating women – History of radiation to the head and neck region – Paranasal sinus tumor is recurrent after prior treatment – Presence of cervical node metastasis – Presence of distant metastasis – Advanced nasopharyngeal malignancy with sphenoid or posterior ethmoid invasion

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Tennessee
  • Collaborator
    • North American Skull Base Society
  • Overall Official(s)
    • Sandeep Samant, MS, FRCS, Study Chair, University of Tennessee
    • Sandeep Samant, MS, FRCS, Principal Investigator, University of Tennessee

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