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

Not Applicable

Completed

• Conditions: Lung Cancer
• Interventions: Procedure: computed tomography; Procedure: positron emission tomography

• Registration Number: NCT00310219
• Lead Sponsor: Radiation Therapy Oncology Group

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2006-03-29
• Study First Submitted QC: 2006-03-29
• Study First Posted: 2006-04-03
• Primary Completion: 2010-11
• Study Completion: 2013-11
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-23
• Last Update Posted: 2014-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	positron emission tomography	Two radiation oncologists are randomly assigned to develop either a 3DCRT plan using CT only, or a 3DCRT plan using fused PET/CT
Arm 1	computed tomography	Two radiation oncologists are randomly assigned to develop either a 3DCRT plan using CT only, or a 3DCRT plan using fused PET/CT

Primary Outcome Measures

Name	Time	Method
The impact of positron emission tomography (PET)/CT fusion planning on GTV (cm³) vs. planning with CT scan alone	Two treatment plans are centrally reviewed to determine the difference in gross tumor volume between the plans
The impact of positron emission tomography (PET)/CT fusion planning on number of contoured lymph nodes vs. planning with CT scan alone	Two treatment plans are centrally reviewed to determine the difference in number of contoured lymph nodes between the plans
The impact of positron emission tomography (PET)/CT fusion planning on lung V20 vs planning with CT scan alone	Two treatment plans are centrally reviewed to determine the difference in lung V20 between the plans
The impact of positron emission tomography (PET)/CT fusion planning on location of involved lymph nodes vs planning with CT scan alone	Two treatment plans are centrally reviewed to determine the difference in location of involved lymph nodes between the plans
The impact of positron emission tomography (PET)/CT fusion planning vs planning with CT scan alone on mean esophagus dose	Two treatment plans are centrally reviewed to determine the difference in mean esophagus dose between the plans

Secondary Outcome Measures

Name	Time	Method
Rate of elective nodal failures as assessed by failure in previously uninvolved regional lymph nodes at 2 years	From registration to 2 years

Trial Locations

Locations (4)

Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - Saint Louis; 🇺🇸 St Louis, Missouri, United States

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas; 🇺🇸 Dallas, Texas, United States

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center; 🇺🇸 Madison, Wisconsin, United States

McGill Cancer Centre at McGill University; 🇨🇦 Montreal, Canada