Computed Tomography in Detecting Movement of the Esophagu... | NCT00433524

Studies
Computed Tomography in Detecting Movement of the Esophagus in Patients Undergoing Radiation Therapy to the Chest

NCT00433524

Sponsor

Fox Chase Cancer Center

Status

Completed

Last Update Posted

Feb 12, 2010Estimated

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Interventions

computed tomography

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

ID	Type	Description	Link
P30CA006927	U.S. NIH Grant/Contract		View source
FCCC-03604

Status Module

Record Verification Date

Feb 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2003

Primary Completion Date

Not provided

Completion Date

Sep 2007Actual

First Submitted Date

Feb 8, 2007

First Submission Date that Met QC Criteria

Feb 8, 2007

First Posted Date

Feb 12, 2007Estimated

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 11, 2010

Last Update Posted Date

Feb 12, 2010Estimated

Name	Class
National Cancer Institute (NCI)	NIH

Description Module

Brief Summary

RATIONALE: Comparing results of diagnostic procedures, such as computed tomography scan (CT scan), done before and after radiation therapy to help detect movement of the esophagus may help doctors plan the best treatment.

PURPOSE: This clinical trial is using CT scan to help detect movement of the esophagus in patients undergoing radiation therapy to the chest.

Detailed Description

OBJECTIVES:

Determine the inter- and intra-fraction movement of the esophagus using CT scans in patients undergoing thoracic radiotherapy.

OUTLINE: This is a pilot study.

Patients undergo CT scans at baseline and then once weekly during their scheduled radiotherapy sessions to determine esophageal placement while in the treatment position. CT scans are performed before and after the radiotherapy session. Pretreatment and post-treatment scans are compared.

PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study.

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

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Name	Type	Description	Arm Group Labels	Other Names
computed tomography	Procedure

Measure	Description	Time Frame
Inter- and intra-fraction movement of the esophagus as measured by CT scans

Eligibility Module

Eligibility Criteria

DISEASE CHARACTERISTICS:

Planning to undergo definitive thoracic radiotherapy

PATIENT CHARACTERISTICS:

Age

Not specified

Performance status

Not specified

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Not specified

Renal

Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

Not specified

Radiotherapy

See Disease Characteristics
No concurrent palliative thoracic radiotherapy

Surgery

Not specified

Other

Concurrent participation in other clinical trials allowed

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided