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

NCT01843673 | Completed Results DMC

• 3 other identifiers: MCC-11639NCI-2013-00846HM11639
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer

Keywords

Lip, Oral Cavity and Pharynx; Larynx

Outcome Measures

Primary Outcomes (3)

• Differences of Calculated Set up Errors of 2 mm Between the Different Imaging Technologies

  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.

  up to 7 weeks

• Dose Variation Between the Different Imaging Technologies for Normal Tissue Structures of 10%

  Up to 7 weeks

• Greater Than or Equal to 5% Variation of Normal Tissue Toxicity

  Up to 7 weeks

Study Arms (1)

in-room imaging systems

EXPERIMENTAL

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; Procedure: cone-beam computed tomography; Procedure: radiography; Procedure: electronic portal imaging; Radiation: image-guided adaptive radiation therapy

Interventions

computed tomography PROCEDURE

Undergo FBCT

Also known as: tomography, computed

in-room imaging systems

cone-beam computed tomography PROCEDURE

Undergo dual CBCT

in-room imaging systems

radiography PROCEDURE

Undergo 2-D x-ray with Varian kV OBI

Also known as: Conventional X-Ray, Diagnostic Radiology, Medical Imaging, X-Ray, X-Ray Imaging

in-room imaging systems

electronic portal imaging PROCEDURE

Undergo EPID imaging

Also known as: EPI

in-room imaging systems

image-guided adaptive radiation therapy RADIATION

Undergo IGART

Also known as: IGART, image-guided adaptive radiotherapy

in-room imaging systems

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University, Massey Cancer Center

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Lymphoid Interstitial Pneumonia; Laryngeal Diseases

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Results Point of Contact

• Title: Joshua Evans, Ph.D.
• Organization: Virginia Commonwealth University

jevans2@mcvh-vcu.edu

804-628-0661

Study Officials

• Joshua Evans, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2013
• First Posted: April 30, 2013
• Study Start: January 1, 2009
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: July 6, 2016
• Results First Posted: March 21, 2016

Record last verified: 2016-05

Locations

US (1)