Chemoradiotherapy Followed by Surgery for Advanced Parana... | NCT00347256

Studies
Chemoradiotherapy Followed by Surgery for Advanced Paranasal Sinus Cancer

NCT00347256

Sponsor

University of Tennessee

Status

Withdrawn

Last Update Posted

Dec 10, 2008Estimated

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Paranasal Sinus Neoplasms

Interventions

cisplatin
targeted radiation therapy
tumor resection

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2008

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jun 29, 2006

First Submission Date that Met QC Criteria

Jun 29, 2006

First Posted Date

Jul 4, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 9, 2008

Last Update Posted Date

Dec 10, 2008Estimated

Name	Class
North American Skull Base Society	OTHER

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Local control of cancer at two years post treatment
Response to preoperative chemoradiation

Secondary Outcomes

Measure	Description	Time Frame
Estimation of the proportion of the inoperable tumors which become operable after chemoradiation
Identification of factors that are associated with inoperability

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sandeep Samant, MS, FRCS	University of Tennessee	Study Chair
Sandeep Samant, MS, FRCS	University of Tennessee	Principal Investigator

Locations

Not provided

Label	URL
North American Skull Base Society webpage	View source

Condition Browse Module

MeSH Terms

ID	Term
D010255	Paranasal Sinus Neoplasms

Ancestor Terms

ID	Term
D009669	Nose Neoplasms
D010039	Otorhinolaryngologic Neoplasms
D006258	Head and Neck Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002945	Cisplatin
D011878	Radiotherapy
D000094463	Transurethral Resection of Bladder

Ancestor Terms

ID	Term
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds
D017671	Platinum Compounds

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
cisplatin	Drug
targeted radiation therapy	Procedure
tumor resection	Procedure