Positron Emission Tomography Scan and CT Scan in Planning Radiation Therapy for Patients With Stage II or Stage III Non-Small Cell Lung Cancer

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

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2013-11-30

Brief Summary

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RATIONALE: Imaging procedures, such as positron emission tomography (PET) scan and CT scan, may help doctors plan radiation therapy for patients with non-small cell lung cancer.

PURPOSE: This clinical trial is studying how well a combined PET scan and CT scan works compared to a CT scan alone in planning radiation therapy for patients with stage II or stage III non-small cell lung cancer.

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Detailed Description

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OBJECTIVES:

Primary

* Determine the impact of positron emission tomography (PET)/CT fusion scan and CT scan alone, by comparing gross tumor volume (GTV) contours and three-dimensional conformal radiotherapy treatment plans using 2 separate data sets (PET/CT fusion scan and CT scan only), in patients with stage II or III non-small cell lung cancer who are planning to undergo radiotherapy.
* Determine the impact of PET on GTV (cm\^3), number of involved nodes, location of involved nodes, and dosimetric measures of normal tissue toxicity (mean lung dose, V20, and mean esophageal dose).

Secondary

* Determine the rate of elective nodal failures (nodal failures in regions that are not intentionally irradiated to definitive doses \[i.e., ipsilateral hilum, mediastinum, or ipsilateral supraclavicular fossa\]).

OUTLINE: This is a multicenter study. Patients are stratified according to neoadjuvant chemotherapy (yes vs no).

Patients undergo a combined positron emission tomography (PET)/CT scan. Patients also undergo a CT scan alone. A single three-dimensional conformal radiotherapy (3DCRT) plan is generated from the combined PET/CT scan results. A single 3DCRT plan using the planning target volume is derived from the CT scan only.

Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study.

Conditions

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Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Arm 1

Two radiation oncologists are randomly assigned to develop either a 3DCRT plan using CT only, or a 3DCRT plan using fused PET/CT

Group Type EXPERIMENTAL

computed tomography

Intervention Type PROCEDURE

positron emission tomography

Intervention Type PROCEDURE

Interventions

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computed tomography

Intervention Type PROCEDURE

positron emission tomography

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)

* Stage IIA/IIB or stage IIIA/IIIB disease
* Planning to undergo radiotherapy
* Local or regional nodal recurrence after surgery allowed
* No malignant pleural effusion

PATIENT CHARACTERISTICS:

* Zubrod performance status 0-2
* Negative pregnancy test
* Not pregnant or nursing
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* Concurrent neoadjuvant and/or concurrent chemotherapy allowed
* No concurrent intensity-modulated radiotherapy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No