A Feasibility Study of Adaptive Intensity-Modulated Radiation Therapy

NCT ID: NCT00608751

Last Updated: 2013-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

EARLY_PHASE1

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Head and Neck Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

IMRT

Intervention Type RADIATION

Interventions

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IMRT

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wade Thorstad, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Countries

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United States

Related Links

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http://www.siteman.wustl.edu

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Other Identifiers

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06-1210

Identifier Type: -

Identifier Source: org_study_id

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