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 Overview
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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.

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.

Official Title
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Comparative Study of Gross Tumor Volume Definition With or Without PET Fusion for Patients With Non-Small Cell Lung Carcinoma

Conditions
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Lung Cancer

Intervention / Treatment
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* Procedure: computed tomography
* Procedure: positron emission tomography


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Two radiation oncologists are randomly assigned to develop either a 3DCRT plan using CT only, or a 3DCRT plan using fused PET/CT | Procedure: computed tomography<br> <br> Procedure: positron emission tomography<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 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 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of elective nodal failures as assessed by failure in previously uninvolved regional lymph nodes at 2 years |  | From registration to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, recurrent non-small cell lung cancer