A Feasibility Study of Adaptive Intensity-Modulated Radiation Therapy (IMRT)

This study has been terminated.

(Lack of accrual and software issues)

Sponsor:

Information provided by (Responsible Party):

Washington University School of Medicine

ClinicalTrials.gov Identifier:

NCT00608751

First received: January 2, 2008

Last updated: February 19, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

January 2, 2008

Last Updated Date

February 19, 2013

Start Date ^ICMJE

January 2007

Primary Completion Date

January 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Feasibility of adaptive radiation therapy in the definitive treatment (MLC-based IMRT or helical tomotherapy) [ Time Frame: 7 weeks ] [ Designated as safety issue: Yes ]

Feasibility is determined by employing weekly 3D onboard imaging for plan re-evaluation and initiation of an adaptive process if the original PTV and/or normal structure goals are compromised.

Original Primary Outcome Measures ^ICMJE

We define feasibility as the ability to maintain the planned prescription parameters throughout treatment by delivering 95% of the prescription dose to 99% of the original PTV. [ Time Frame: 2010 ] [ Designated as safety issue: Yes ]

Change History

Complete list of historical versions of study NCT00608751 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Measure additional time required by physician and ancillary staff for the process of adaptive IMRT [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
Recording on a weekly basis the actual time required for repeat CT imaging, plan re-evaluation, replanning, and repeat physics QA.
Identify a subset of patients in whom adaptive IMRT would be recommended [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
Measure acute and late toxicity [ Time Frame: Until patient death ] [ Designated as safety issue: Yes ]
Local, regional, and distant recurrence [ Time Frame: Until recurrence ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Descriptive statistics will be reported for measured times such as mean, median, standard deviation, and range. [ Time Frame: 2010 ] [ Designated as safety issue: Yes ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Feasibility Study of Adaptive Intensity-Modulated Radiation Therapy

Official Title ^ICMJE

A Feasibility Study of Adaptive Intensity-Modulated Radiation Therapy in the Definitive Treatment of Head and Neck Cancer

Brief Summary

Patients with head and neck cancer and are schedule to receive standard radiation therapy known as IMRT to treat cancer

Detailed Description

In this study, we will plan additional measurements of the position of the patient's organs weekly during radiation treatment. We will analyze these measurements in order to evaluate whether we need to adjust our treatment procedures for the remainder of the treatments. We might adjust the dose of radiation received to specific organs in order to try to minimize the amount of radiation the healthy tissue receives.

Study Type ^ICMJE

Interventional

Study Phase

Phase 0

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Head and Neck Cancer

Intervention ^ICMJE

Radiation: IMRT

Study Arm (s)

Experimental: IMRT

External beam radiation with 6 MV photons will be delivered in 200 cGy daily fractions, 35 fractions over 7 weeks for a total dose of 7000 cGy.

Intervention: Radiation: IMRT

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

January 2008

Primary Completion Date

January 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Age >= 18
Karnofsky Performance Status of >= 60
New diagnosis of head-and-neck cancer, all subsites included (i.e. nasopharynx, oropharynx, oral cavity, hypopharynx, larynx.)
All stages with measurable gross disease (>= 1.0 cm) by CT imaging
Pathologic confirmation of squamous cell carcinoma by biopsy or cytology
Signed study-specific consent form
Sequential or concurrent chemotherapy is allowed but not mandated. (no chemotherapy is allowed if patient is judged not to be a candidate for chemotherapy by the medical oncologist)

Exclusion Criteria

Age < 18
Karnofsky Performance Status < 60
Radiographic or pathologic evidence of distant metastatic disease (i.e. other than cervical lymph nodes)
Prior radiation therapy to the head-and-neck region

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00608751

Other Study ID Numbers ^ICMJE

06-1210

Has Data Monitoring Committee

Responsible Party

Washington University School of Medicine

Study Sponsor ^ICMJE

Washington University School of Medicine

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Wade Thorstad, MD

Washington University School of Medicine

Information Provided By

Washington University School of Medicine

Verification Date

February 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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