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

NCT ID: NCT01843673

Last Updated: 2016-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2015-01-31

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.

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.

Conditions

Head and Neck Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

computed tomography

Intervention Type: PROCEDURE

Undergo FBCT

cone-beam computed tomography

Intervention Type: PROCEDURE

Undergo dual CBCT

radiography

Intervention Type: PROCEDURE

Undergo 2-D x-ray with Varian kV OBI

radiography

Intervention Type: PROCEDURE

Undergo 2-D x-ray with Brain Lab ExacTrac

radiography

Intervention Type: PROCEDURE

Undergo 2-D x-ray with Varian MV OBI

electronic portal imaging

Intervention Type: PROCEDURE

Undergo EPID imaging

image-guided adaptive radiation therapy

Intervention Type: RADIATION

Undergo IGART

Interventions

computed tomography

Undergo FBCT

Intervention Type: PROCEDURE

cone-beam computed tomography

Undergo dual CBCT

Intervention Type: PROCEDURE

radiography

Undergo 2-D x-ray with Varian kV OBI

Intervention Type: PROCEDURE

radiography

Undergo 2-D x-ray with Brain Lab ExacTrac

Intervention Type: PROCEDURE

radiography

Undergo 2-D x-ray with Varian MV OBI

Intervention Type: PROCEDURE

electronic portal imaging

Undergo EPID imaging

Intervention Type: PROCEDURE

image-guided adaptive radiation therapy

Undergo IGART

Intervention Type: RADIATION

Other Intervention Names

tomography, computed; Conventional X-Ray, Diagnostic Radiology, Medical Imaging, X-Ray, X-Ray Imaging; Conventional X-Ray, Diagnostic Radiology, Medical Imaging, X-Ray, X-Ray Imaging; Conventional X-Ray, Diagnostic Radiology, Medical Imaging, X-Ray, X-Ray Imaging; EPI; IGART, image-guided adaptive radiotherapy

Eligibility 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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joshua Evans, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virginia Commonwealth University, Massey Cancer Center

Richmond, Virginia, United States

Countries

United States

Other Identifiers

NCI-2013-00846

Identifier Type: REGISTRY

Identifier Source: secondary_id

HM11639

Identifier Type: OTHER

Identifier Source: secondary_id

MCC-11639

Identifier Type: -

Identifier Source: org_study_id