Trial | NCT00347256  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Withdrawn

  • Intervention/Treatment

    cisplatin ...

  • Study Participants

    60
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.
Study Started
Jun 29
2006
Last Update
Dec 10
2008
Estimate

Drug cisplatin

Procedure targeted radiation therapy

Procedure tumor resection

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
No Results Posted