Chemoradiotherapy Followed by Surgery for Advanced Paranasal Sinus Cancer

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Tennessee
• Collaborator: North American Skull Base Society
• Treatments: Cisplatin

Criteria

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