A New Radiation Therapy Planning System in Patients Under... | NCT00436397

Studies
A New Radiation Therapy Planning System in Patients Undergoing Radiation Therapy for Cancer

NCT00436397

Sponsor

Fox Chase Cancer Center

Status

Completed

Last Update Posted

Feb 12, 2010Estimated

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Interventions

radiation therapy

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-02604

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

Jun 2002

Primary Completion Date

Not provided

Completion Date

Aug 2005Actual

First Submitted Date

Feb 15, 2007

First Submission Date that Met QC Criteria

Feb 15, 2007

First Posted Date

Feb 19, 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: A new radiation therapy planning system may help doctors plan better treatment for patients with cancer.

PURPOSE: This clinical trial is studying a new radiation therapy planning system in patients undergoing radiation therapy for extracranial cancer.

Detailed Description

OBJECTIVES:

Determine the ability of the Radionics Body System™ to immobilize and re-localize patients receiving radiotherapy to extra-cranial sites of cancer.
Determine the accuracy of radiation dose calculations for extra-cranial sites of cancer when using the XPLAN™-intensity modulated radiation therapy (XPLAN™/IMRT) integrated software in this system.

OUTLINE: Patients receiving radiotherapy have a Body Localizer cast constructed and undergo a CT scan while immobilized in the Body Localizer. Patients undergo another CT scan in the treatment position using the standard alpha cradle. The XPLAN™-intensity modulated radiation therapy (XPLAN™/IMRT)-generated treatment plan is compared to the standard treatment plan to verify that the calculated dose is within 2-3 percent of the planned dose using standard technique. Patients undergo sets of CT scans 3 additional times over the next few weeks for a total of 8 CT scans Patients may undergo additional CT scans before and after radiotherapy treatments for a maximum of 5 CT scans per week performed over the course of radiotherapy.

PROJECTED ACCRUAL: Approximately 60 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

60Estimated

Name	Type	Description	Arm Group Labels	Other Names
radiation therapy	Radiation

Eligibility Module

Eligibility Criteria

DISEASE CHARACTERISTICS:

Cancer for which a course of radiotherapy to an extra-cranial site is required
- Head and neck sites excluded
Initial treatment field (or cone down field) must be no greater than 12 X 10 cm

PATIENT CHARACTERISTICS:

Age

Not specified

Performance status

Not specified

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Not specified

Renal

Not specified

Cardiovascular

No right heart insufficiency

Other

Not pregnant or nursing
Fertile patients must use effective contraception
Weight must not exceed 150 kilograms (330 pounds)

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

Not specified

Radiotherapy

See Disease Characteristics

Surgery

Not specified

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