A Feasibility Study of Adaptive Intensity-Modulated Radiation Therapy

Early Phase 1TerminatedNCT00608751

Washington University School of Medicine5 enrolled

Overview

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

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

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Head and Neck Cancer

Interventions

IMRTRADIATION

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Washington University School of Medicine

St Louis, Missouri, United States

Outcomes

Primary Outcomes

Feasibility of adaptive radiation therapy in the definitive treatment (MLC-based IMRT or helical tomotherapy)

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.

Time frame: 7 weeks

Secondary Outcomes

Measure additional time required by physician and ancillary staff for the process of adaptive IMRT

Recording on a weekly basis the actual time required for repeat CT imaging, plan re-evaluation, replanning, and repeat physics QA.

Time frame: 7 weeks

Identify a subset of patients in whom adaptive IMRT would be recommended

Time frame: 7 weeks

Measure acute and late toxicity

Time frame: Until patient death

Local, regional, and distant recurrence

Time frame: Until recurrence

Data from ClinicalTrials.gov

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