Photon/Proton Radiation Therapy for Carcinoma of the Skin... | NCT00797043

Studies
Photon/Proton Radiation Therapy for Carcinoma of the Skin of the Head and Neck

NCT00797043

Sponsor

University of Florida

Status

Terminated

Last Update Posted

Feb 7, 2017Estimated

Enrollment

11Actual

Phase

Not provided

Conditions

Malignant Neoplasm of Skin Head and Neck

Interventions

Not provided

Countries

United States

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

Feb 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Slow enrollment, feasibility issues

Expanded Access Info

Start Date

Sep 2008

Primary Completion Date

Jul 2015Actual

Completion Date

Jul 2015Actual

First Submitted Date

Nov 24, 2008

First Submission Date that Met QC Criteria

Nov 24, 2008

First Posted Date

Nov 25, 2008Estimated

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

Feb 3, 2017

Last Update Posted Date

Feb 7, 2017Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to collect information from the questionnaire and your medical records to see what effects the proton radiation has on you and your cancer and collect and analyze morbidity outcomes: Incidence of xerostomia (dry mouth) and tumor control.

Detailed Description

Data collection will be obtained from the patient's medical records including initial evaluation, pathology report, dosimetry information, radiotherapy completion records and follow-up.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

11Actual

Label	Type	Description	Intervention Names
Photon/Proton Radiation Therapy		Data consolidation and analysis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Collect and analyze morbidity outcomes: Incidence of grade 3 or higher xerostomia (dry mouth)		1 year following the completion of radiation therapy

Secondary Outcomes

Measure	Description	Time Frame
Collect and analyze tumor control outcomes.		When each patient has been followed for a minimum of 6 months and then again at 24 months.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Carcinoma of the skin of the head and neck region with incidental or symptomatic perineural invasion.
Biopsy-proven squamous cell carcinoma.
Will receive treatment with proton radiation.

Exclusion Criteria:

Evidence of distant metastasis.
Previous irradiation for head and neck cancer.

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

Patients treated at radiation oncology clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Roi Dagan, MD, MS	University of Florida	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Florida Proton Therapy Institute		Jacksonville	Florida	32206	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
14070757	Background	BALLANTYNE AJ, MCCARTEN AB, IBANEZ ML. THE EXTENSION OF CANCER OF THE HEAD AND NECK THROUGH PERIPHERAL NERVES. Am J Surg. 1963 Oct;106:651-67. doi: 10.1016/0002-9610(63)90074-6. No abstract available.
6749931	Background	Cottel WI. Perineural invasion by squamous-cell carcinoma. J Dermatol Surg Oncol. 1982 Jul;8(7):589-600. doi: 10.1111/j.1524-4725.1982.tb00317.x.