Positron Emission Tomography (PET) Imaging in Stage III Non-small Cell Lung Cancer (PET START Trial)

Study Overview
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Brief Summary
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Locally advanced non-small cell lung cancer, NSCLC, (Stage III) is potentially curable with aggressive combined modality therapy (chemotherapy and radiation). Conventional imaging can only evaluate gross anatomic abnormalities but functional imaging with positron emission tomography (PET) may more accurately identify patients who will benefit from aggressive combined modality therapy. This prospective randomized clinical trial will enroll 400 patients that have undergone conventional staging for lung cancer and have been found to have Stage III NSCLC. The patients will then be randomized to either standard combined modality therapy for Stage III NSCLC or to PET imaging prior to combined modality therapy with curative intent. Based on the PET findings, patients will either be suitable for combined modality therapy with curative intent or not.

Official Title
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The Impact of Positron Emission Tomography (PET) Imaging in Stage III Non-small Cell Lung Cancer: A Prospective Randomized Clinical Trial (PET START Trial)

Conditions
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Non-Small-Cell Lung Carcinoma

Intervention / Treatment
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* Procedure: PET Diagnostic Imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histological or cytological evidence of NSCLC. Must have documented pathology report with histology indicated (e.g. squamous, adenocarcinoma, large cell, NSCLC not otherwise specified). Stage III (mediastinal node positive) NSCLC based on conventional staging (e.g. computed tomography [CT] scan of chest and upper abdomen, CT or magnetic resonance imaging [MRI] of brain, bone scan). Suitable for combined modality (chemotherapy and radiation) therapy or radical radiation therapy or trimodality therapy (chemotherapy, radiation and surgery). Exclusion Criteria: Stage IV NSCLC (by conventional staging). Small cell lung cancer. Poor performance status Eastern Cooperative Oncology Group (ECOG) 3-4. Poor pulmonary function precluding radical radiation therapy (Adequate pulmonary reserve for radical radiation therapy. Pulmonary function tests should have forced expiratory volume in 1 second (FEV1) > 1.0 liter or > 40% predicted, diffusing capacity of the lung for carbon monoxide (DLCO) > 45% and/or predicted contralateral FEV1 > 800 cc based on quantitative ventilation perfusion lung scan). Significant concurrent medical problems (e.g. uncontrolled diabetes, active cardiac problems, significant chronic obstructive pulmonary disease). Insulin dependent diabetic where requirements for PET imaging may be problematic. Unable to lie supine for at least 30 minutes in radiation treatment position for imaging with PET. Failure to provide informed consent. Previous PET scan relating to recent cancer diagnosis prior to entry into study. Pregnant or lactating females. Prior thoracic radiation. Prior malignancy within 3 years from randomization (except nonmelanotic skin cancer or carcinoma in situ of the cervix). Administered more than two cycles of chemotherapy prior to radical radiation therapy or concurrent chemoradiation (as part of induction or sequential chemotherapy prior to randomization) for the current malignancy.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>PET Imaging | Procedure: PET Diagnostic Imaging<br>* Patients in the PET group will undergo the standard diagnostic tests plus PET to determine those suitable for combined modality therapy<br>|
| No Intervention: 2<br>Standard Imaging | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stage III NSCLC patients upstaged by PET |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 2 years | 
| Impact of PET on radiation treatment planning |  | 2 years | 
| Prognostic ability of PET standard uptake value |  | 2 years | 
| Number of patients downstaged by PET |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oncology, Positron-Emission Tomography, PET Scan, Non-Small-Cell Lung Carcinoma, Diagnosis, Radiation Oncology, Lung Cancer, Randomized Controlled Trial, Radiation Planning