Chemoradiotherapy Followed by Surgery for Advanced Paranasal Sinus Cancer

Paranasal Sinus Neoplasms Clinical Trial

Official title:

Preoperative Radiotherapy and Concomitant Chemotherapy Followed by Surgery for Advanced Paranasal Sinus Carcinoma

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00347256
• Other study ID #: NASBS-PNS001
• Status: Withdrawn
• Phase: N/A
• First received: June 29, 2006
• Last updated: December 9, 2008

Study information

• Verified date: December 2008
• Source: University of Tennessee
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Department of Health and Human ServicesUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 60
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Paranasal Sinus Neoplasms

Intervention

Drug:
• cisplatin

Procedure:
• targeted radiation therapy

• tumor resection

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Tennessee	North American Skull Base Society

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local control of cancer at two years post treatment
Primary	Response to preoperative chemoradiation
Secondary	Estimation of the proportion of the inoperable tumors which become operable after chemoradiation
Secondary	Identification of factors that are associated with inoperability
Secondary	Estimation of the overall survival and cumulative incidence of death due to disease at 2 years
Secondary	Determination of the acute and long-term toxicity, particularly ophthalmologic complications, and surgical morbidity associated with this regimen
Secondary	Measurement of the accuracy of conventional imaging techniques (CT, MRI) compared with the addition of PET imaging in predicting the response to chemoradiation therapy.

External Links

•   North American Skull Base Society webpage