Chemoradiotherapy Followed by Surgery for Advanced Paranasal Sinus Cancer

NCT00347256 | Withdrawn

• 1 other identifier: NASBS-PNS001
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Paranasal Sinus Neoplasms

Outcome Measures

Primary Outcomes (2)

• Local control of cancer at two years post treatment

• Response to preoperative chemoradiation

Secondary Outcomes (5)

• 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.

Interventions

cisplatin DRUG

targeted radiation therapy PROCEDURE

tumor resection PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Tennessee: lead
• North American Skull Base Society: collaborator

Related Links

• North American Skull Base Society webpage

MeSH Terms

Conditions

Paranasal Sinus Neoplasms

Interventions

Cisplatin; Radiotherapy; Transurethral Resection of Bladder

Condition Hierarchy (Ancestors)

Nose Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Nose Diseases; Respiratory Tract Diseases; Paranasal Sinus Diseases; Respiratory Tract Neoplasms; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Therapeutics; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Sandeep Samant, MS, FRCS

  University of Tennessee

  STUDY CHAIR

• Sandeep Samant, MS, FRCS

  University of Tennessee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 29, 2006
• First Posted: July 4, 2006
• Last Updated: December 10, 2008

Record last verified: 2008-12