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Image-Guided Adaptive Radiotherapy for in Detecting Tumors During Treatment in Patients With Head and Neck Cancer

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ClinicalTrials.gov Identifier: NCT01843673
Recruitment Status : Completed
First Posted : April 30, 2013
Results First Posted : March 21, 2016
Last Update Posted : July 6, 2016
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

Brief Summary:
This clinical trial studies image-guided adaptive radiotherapy in detecting tumors during treatment in patients with head and neck cancer. Image-guided adaptive radiotherapy uses high quality imaging technology to detect the tumor and normal organs during treatment. It is not yet known which imaging technique provides the best image for guidance during treatment with radiation therapy. Comparing results of imaging procedures done before, during, and after radiotherapy may help doctors plan the best treatment.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Procedure: computed tomography Procedure: cone-beam computed tomography Procedure: radiography Procedure: electronic portal imaging Radiation: image-guided adaptive radiation therapy Not Applicable

Detailed Description:

I. To conduct a clinical imaging study utilizing three novel in-room imaging systems: Oblique Brainlab ExacTrac images, Orthogonal Varian kilovoltage (kV) On-board Imaging (OBI) image, and Varian cone-beam computed tomography (CBCT) imaging to assess their performance in reducing inter- and intrafractional setup errors, relative to weekly megavoltage (MV) electronic portal imaging device (EPID) images, using both bony landmarks and soft tissue changes for head and neck cancer (HNC) patients undergoing external beam radiation therapy (RT).

II. To assess the accuracy of CBCT imaging for measuring systematic soft tissue changes in the head and neck (HN) area relative to conventional high resolution contrast enhanced fan-beam computed tomography (CT) (FBCT) as a standard.

III. To assess the systematic and random soft tissue motion errors using daily CBCT imaging relative to bony-landmark alignment to evaluate the benefit of soft tissue imaging during radiotherapy.

IV. To quantify soft tissue changes during an entire course of radiotherapy (e.g. tumor shrinkage) using daily CBCT imaging.

V. To determine the feasibility of using measured set up and soft-tissue motion uncertainties in conjunction with volume changes observed on serial CBCT images, for offline adaptive replanning of HNC patients using available planning tools.

VI. To quantify the benefits of adaptive image-guided radiotherapy (IGRT) in HN patients in terms of target coverage and normal tissue avoidance.

VII. To determine the feasibility of mounting a phase I/II trial to assess the clinical benefits of image-guided adaptive radiotherapy (IGART) in terms of acute and late toxicities and tumor control.

VIII. To build a HNC patient database for future validation of IGART processes using deformable image registration and Virtual Clinical Trials (VCTs).

OUTLINE:

Patients undergo FBCT once before treatment and once weekly for a total of 6-7 scans, dual CBCT up to 5 times weekly for a total of 33-35 scans, 2-dimensional (2-D) x-ray with Varian kV OBI 5 times weekly for a total of 33-35 scans, 2-D x-ray with Brain Lab ExacTrac 5 times weekly for a total of 33-35 scans, 2-D x-ray with Varian MV OBI once weekly for a total of 6-7 scans, and EPID imaging up to 5 times weekly for a total of 33-35 scans while undergoing IGART.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Image-Guided Adaptive Radiotherapy for Head And Neck Cancer: Patient Image Acquisition
Study Start Date : January 2009
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: in-room imaging systems
Patients undergo FBCT once before treatment and once weekly for a total of 6-7 scans, dual CBCT up to 5 times weekly for a total of 33-35 scans, 2-D x-ray with Varian kV OBI 5 times weekly for a total of 33-35 scans, 2-D x-ray with Brain Lab ExacTrac 5 times weekly for a total of 33-35 scans, 2-D x-ray with Varian MV OBI once weekly for a total of 6-7 scans, and EPID imaging up to 5 times weekly for a total of 33-35 scans while undergoing IGART.
Procedure: computed tomography
Undergo FBCT
Other Name: tomography, computed

Procedure: cone-beam computed tomography
Undergo dual CBCT

Procedure: radiography
Undergo 2-D x-ray with Varian kV OBI
Other Name: Conventional X-Ray, Diagnostic Radiology, Medical Imaging, X-Ray, X-Ray Imaging

Procedure: radiography
Undergo 2-D x-ray with Brain Lab ExacTrac
Other Name: Conventional X-Ray, Diagnostic Radiology, Medical Imaging, X-Ray, X-Ray Imaging

Procedure: radiography
Undergo 2-D x-ray with Varian MV OBI
Other Name: Conventional X-Ray, Diagnostic Radiology, Medical Imaging, X-Ray, X-Ray Imaging

Procedure: electronic portal imaging
Undergo EPID imaging
Other Name: EPI

Radiation: image-guided adaptive radiation therapy
Undergo IGART
Other Name: IGART, image-guided adaptive radiotherapy




Primary Outcome Measures :
  1. Differences of Calculated Set up Errors of 2 mm Between the Different Imaging Technologies [ Time Frame: up to 7 weeks ]
    The automated patient setup procedure varies between 'OBI', 'CBCT' or 'Exactrac' imaging technologies. Each procedure gives two shifts: 'vertical' and 'lateral'. In the absence of a gold standard, our goal is to compare the shifts recommended by each pair of automated patient setup procedures. Average and Std deviation of vertical and lateral motion from the three systems were computed. P value, 1.00, refers to the test of difference of each system with OBI being more than 2 mm. Pairwise comparison for each direction between each pair of technologies were done using a t test to check if the difference in the recommended shift is more than 2 mm. The reported mean value represents the shift from planned treatment position averaged over all daily treatment setups. A negative mean vertical value indicates the patient was consistently set up posterior to plan; a negative mean lateral value indicates a set up consistently right of plan.

  2. Dose Variation Between the Different Imaging Technologies for Normal Tissue Structures of 10% [ Time Frame: Up to 7 weeks ]
  3. Greater Than or Equal to 5% Variation of Normal Tissue Toxicity [ Time Frame: Up to 7 weeks ]


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologic or cytologic confirmation of head and neck malignancy
  • Patients who will be treated with definitive radiation therapy or concurrent chemoradiation therapy
  • Gross tumor volume (GTV) must be visible on CT
  • All patients must be informed of the investigational nature of this study and must give written informed consent in accordance with institutional and federal guidelines

Exclusion Criteria:

  • Pregnant or nursing women may not participate; women of reproductive potential must be offered a pre-treatment pregnancy test and informed of the need to practice an effective contraceptive method
  • Prior treatment with radiation therapy to the head and neck
  • Serum creatinine > 1.5 and/or
  • Blood urea nitrogen [BUN] > 25
  • Treatment with any prior chemotherapy or surgery (excluding diagnostic biopsy) for this malignancy
  • Patients with known syndromes expected to alter radiosensitivity (e.g. ataxia-telangiectasia, scleroderma, lupus, human immunodeficiency virus [HIV]/acquired immunodeficiency deficiency syndrome [AIDS]) may not participate

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): NCT01843673


Locations
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United States, Virginia
Virginia Commonwealth University, Massey Cancer Center
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
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Principal Investigator: Joshua Evans, PhD Virginia Commonwealth University

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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01843673     History of Changes
Other Study ID Numbers: MCC-11639
NCI-2013-00846 ( Registry Identifier: NCI )
HM11639 ( Other Identifier: Virginia Commonwealth University IRB )
First Posted: April 30, 2013    Key Record Dates
Results First Posted: March 21, 2016
Last Update Posted: July 6, 2016
Last Verified: May 2016

Keywords provided by Virginia Commonwealth University:
Lip, Oral Cavity and Pharynx
Larynx

Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms