Adaptive Radiation Therapy for Head & Neck Cancer Patients

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

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2015-01-31

Brief Summary

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The purpose of this study is to determine the utility of kilovoltage (kV) cone beam CT imaging to track the dose delivered in head and neck cancer patients, to assess the benefit of cone beam CT to patients set-up for radiation treatment, to determine how shifts based on kV cone beam CT compare to the standard approach (orthogonal pair), and to develop remote access tools (preferably internet-based) so that the MD can approve these plans in real time.

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Detailed Description

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The investigators' secondary objectives for this study are to assess the possibility of using kV cone beam for treatment replanning as compared to standard the treatment planning, to determine the need and feasibility of adaptive radiation therapy, to develop concept of establishing cumulative DVH (C-DVH) with daily updates and compare it to planned DVH (P-DVH), to identify tolerance margins, to evaluate local control, locoregional control, distant metastasis, and overall survival, to assess patient quality of life,and to develop predictors of patients which may benefit from ART.

Conditions

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Cancer of Head and Neck

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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definitive radiation + concomitant chemo

Concurrent chemo + IGRT:

These patients will have chemotherapy during the time of radiation treatment

Group Type EXPERIMENTAL

concurrent chemo + IGRT

Intervention Type RADIATION

neoadjuvant chemo

Neoadjuvant chemo + IGRT:

These patients will have chemotherapy prior to other radiation treatment.

Group Type EXPERIMENTAL

neoadjuvant chemo + IGRT

Intervention Type RADIATION

Interventions

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concurrent chemo + IGRT

Intervention Type RADIATION

neoadjuvant chemo + IGRT

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Patients should have an ECOG (Eastern Clinical Oncology Group) performance status of 0-2
* Patients should meet at least one of the following criteria:

1. Locally advanced cancer (T3-T4 and/or N2-N3)
2. Tumors wrapping around critical structures such as the optic nerves, optic chiasm, or brainstem
3. Significant expected weight loss.

Exclusion Criteria

* Previous surgical procedure more significant than a biopsy to the primary tumor or regional lymph nodes.
* Poor renal function (inability to undergo a CT with IV contrast)
* Previous radiation therapy to the head and neck.
* Inability to tolerate prolonged immobilization.
* Children and women who are pregnant or decline to use contraception.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No