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A Feasibility Study of Adaptive Intensity-Modulated Radiation Therapy

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

Status
Terminated
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00608751
Acronym
IMRT
Enrollment
5
Registered
2008-02-06
Start date
2007-01-31
Completion date
2008-01-31
Last updated
2013-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer

Keywords

Newly Diagnosed 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.

Interventions

RADIATIONIMRT

Sponsors

Washington University School of Medicine
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of adaptive radiation therapy in the definitive treatment (MLC-based IMRT or helical tomotherapy)7 weeksFeasibility 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.

Secondary

MeasureTime frameDescription
Measure additional time required by physician and ancillary staff for the process of adaptive IMRT7 weeksRecording 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 recommended7 weeks
Measure acute and late toxicityUntil patient death
Local, regional, and distant recurrenceUntil recurrence

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026