Comparative Study of Gross Tumor Volume Definition With or Without PET Fusion for Patients With Non-Small Cell Lung Carcinoma
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 52
- Locations
- 8
- Primary Endpoint
- The impact of positron emission tomography (PET)/CT fusion planning on GTV (cm³) vs. planning with CT scan alone
Study Overview
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]).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
The impact of positron emission tomography (PET)/CT fusion planning on GTV (cm³) vs. planning with CT scan alone
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: Two treatment plans are centrally reviewed to determine the difference in mean esophagus dose between the plans
Secondary Outcomes
- Rate of elective nodal failures as assessed by failure in previously uninvolved regional lymph nodes at 2 years(From registration to 2 years)