Fludeoxyglucose F18 Positron Emission Tomography Imaging In Assessing Patients Before and After Treatment for Locally Advanced Non-Small Cell Lung Cancer

Study Overview
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Brief Summary
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RATIONALE: Imaging procedures, such as fludeoxyglucose F18 positron emission tomography (^18FDG-PET), may improve the ability to detect disease progression and help doctors predict a patient's response to treatment and plan more effective treatment. PURPOSE: This phase II trial is studying how well ^18FDG-PET imaging works in detecting disease progression and determining response to treatment in patients who are undergoing chemoradiotherapy for locally advanced non-small cell lung cancer.

Detailed Description
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OBJECTIVES: Primary Determine whether peak standardized uptake value (SUV) for fludeoxyglucose F 18 positron emission tomography (FDG-PET) shortly after definitive chemoradiotherapy is predictive of long-term survival of patients with inoperable stage IIB or III non-small cell lung cancer. Secondary Determine whether max SUV for FDG-PET shortly after definitive chemoradiotherapy is predictive of long-term survival in these patients. Determine whether post-treatment imaging using peak and max SUV for FDG-PET shortly after definitive chemoradiotherapy is predictive of local disease control in these patients. Determine whether pre-treatment imaging using these techniques is predictive of long-term survival and local disease control in these patients. Correlate, if possible, Ki-67 expression with overall survival of patients assessed with these imaging techniques. OUTLINE: This is a diagnostic, multicenter study. Before starting chemoradiotherapy, patients undergo baseline whole-body positron emission tomography (PET) imaging. Patients receive fludeoxyglucose F 18 (^18FDG) IV followed 50-70 minutes later by PET imaging. Patients then receive concurrent definitive radiotherapy and chemotherapy. Patients enrolled in other treatment-oriented clinical trials receive therapy as per that trial. Other patients receive standard thoracic radiotherapy (dose ≥ 60 Gy) and standard chemotherapy comprising a platin (cisplatin or carboplatin) and a second non-platin, non-gemcitabine drug (etoposide, vinblastine, vinorelbine, paclitaxel, or docetaxel). Approximately 14 weeks after completion of chemoradiotherapy and adjuvant chemotherapy (if given), patients undergo post-treatment ^18FDG-PET imaging. Patients are followed every 3 months for 2 years and then every 6 months for at least 1 year. PROJECTED ACCRUAL: A total of 250 patients (including at least 75 with stage IIB/IIIA disease and at least 75 with stage IIIB disease) will be accrued for this study within 2 years.

Official Title
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Positron Emission Tomography Pre- and Post-treatment Assessment For Locally Advanced Non-Small Cell Lung Carcinoma

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: carboplatin
* Drug: cisplatin
* Drug: docetaxel
* Drug: etoposide
* Drug: paclitaxel
* Drug: vinblastine sulfate
* Drug: vinorelbine tartrate
* Genetic: gene expression analysis
* Procedure: positron emission tomography
* Radiation: fludeoxyglucose F 18
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed non-small cell lung cancer (NSCLC) Clinical stage IIB or III disease No small cell carcinoma No stage IV disease* No diffuse bronchoalveolar subtype No planned definitive surgical resection NOTE: *Patients with evidence of stage IV disease by positron emission tomography are eligible if the evidence cannot be confirmed by other means AND the physician still plans to proceed with definitive chemoradiation Planning treatment with definitive chemoradiotherapy May be treated on another Radiation Therapy Oncology Group protocol (except phase I studies) OR with conventional concurrent NSCLC chemoradiotherapy Radiotherapy ≥ 60 Gy AND chemotherapy to include concurrent platinum-based therapy No brain metastases by head CT scan or MRI PATIENT CHARACTERISTICS: Age 18 and over Performance status Zubrod 0-1 Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Not specified Other Medically suitable for early concurrent chemoradiotherapy (radiotherapy dose ≥ 60 Gy) Able to tolerate positron emission tomography imaging No poorly controlled diabetes (defined as fasting glucose level > 200 mg/dL) No other malignancy within the past 3 years except basal cell or squamous cell skin cancer or carcinoma in situ Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy No anticipated use of adjuvant biologic therapy beyond 14 weeks after the completion of radiotherapy Chemotherapy See Disease Characteristics No anticipated use of adjuvant chemotherapy beyond 14 weeks after the completion of radiotherapy Endocrine therapy Not specified Radiotherapy See Disease Characteristics No prior thoracic radiotherapy No concurrent intensity-modulated radiotherapy Surgery See Disease Characteristics

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
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: carboplatin|nan|
|Drug: cisplatin|nan|
|Drug: docetaxel|nan|
|Drug: etoposide|nan|
|Drug: paclitaxel|nan|
|Drug: vinblastine sulfate|nan|
|Drug: vinorelbine tartrate|nan|
|Genetic: gene expression analysis|nan|
|Procedure: positron emission tomography|nan|
|Radiation: fludeoxyglucose F 18|nan|
|Radiation: radiation therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship of survival to post-treatment peak standardized uptake value (SUV) as determined by the imaging institution |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship of survival to post-treatment max SUV as determined by the imaging institute |  |  | 
| Relationship of local control to post-treatment peak and max SUV as determined by the imaging institution |  |  | 
| Relationship of survival and of local control to pre-treatment peak and max SUV as determined by the imaging institution |  |  | 
| Reliability between peak and max SUV measurements both pre- and post-treatment |  |  | 
| Proportion of participants who are either upstaged or downstaged by positron emission tomography scan |  |  | 
| Reliability between PET scan-defined response to therapy measurements |  |  | 
| Correlation of Ki-67 expression with peak and max pre-treatment SUV |  |  | 
| Association between Ki-67 expression and overall survival at 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