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

Head and Neck Cancer Clinical Trial

Official title:

Image-Guided Adaptive Radiotherapy for Head And Neck Cancer: Patient Image Acquisition

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01843673
• Other study ID #: MCC-11639
• Secondary ID: NCI-2013-00846HM
• Status: Active, not recruiting
• Phase: N/A
• First received: April 26, 2013
• Last updated: October 29, 2015
• Start date: January 2009
• Est. completion date: July 2016

Study information

• Verified date: October 2015
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 16
• Est. completion date: July 2016
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Procedure:
• computed tomography
Undergo FBCT
• cone-beam computed tomography
Undergo dual CBCT
• radiography
Undergo 2-D x-ray with Varian kV OBI
• radiography
Undergo 2-D x-ray with Brain Lab ExacTrac
• radiography
Undergo 2-D x-ray with Varian MV OBI
• electronic portal imaging
Undergo EPID imaging

Radiation:
• image-guided adaptive radiation therapy
Undergo IGART

Locations

Country	Name	City	State
United States	Virginia Commonwealth University, Massey Cancer Center	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences of calculated set up and tissue-motion errors of 2 mm between the different imaging technologies	A paired t-test with a 0.050 two-sided significance level will be used.	up to 7 weeks	No
Primary	Dose variation between the different imaging technologies for normal tissue structures of 10%	A paired t-test with a 0.050 two-sided significance level will be used.	Up to 7 weeks	No
Primary	Greater than or equal to 5% variation of normal tissue toxicity	A paired t-test with a 0.050 two-sided significance level will be used.	Up to 7 weeks	No