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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00436397
First Posted: February 19, 2007
Last Update Posted: February 12, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Fox Chase Cancer Center
  Purpose

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.


Condition Intervention
Unspecified Adult Solid Tumor, Protocol Specific Radiation: radiation therapy

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Evaluation of the Radionics Body Localizer System and XPLAN/IMRT for Extra-Cranial Sites: A Pilot Study

Further study details as provided by Fox Chase Cancer Center:
Estimated Enrollment: 60
Study Start Date: June 2002
Study Completion Date: August 2005
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00436397


Locations
United States, Pennsylvania
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States, 19111-2497
Sponsors and Collaborators
Fox Chase Cancer Center
National Cancer Institute (NCI)
Investigators
Study Chair: Steven Seigenberg, MD Fox Chase Cancer Center
  More Information

ClinicalTrials.gov Identifier: NCT00436397     History of Changes
Other Study ID Numbers: CDR0000304713
P30CA006927 ( U.S. NIH Grant/Contract )
FCCC-02604
First Submitted: February 15, 2007
First Posted: February 19, 2007
Last Update Posted: February 12, 2010
Last Verified: February 2010

Keywords provided by Fox Chase Cancer Center:
unspecified adult solid tumor, protocol specific


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