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

American College of Radiology Imaging Network250 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (49)

Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham

Birmingham, Alabama, United States

Scottsdale Medical Imaging, Limited

Scottsdale, Arizona, United States

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, United States

Radiological Associates of Sacramento Medical Group at Sutter Cancer Center

Sacramento, California, United States

Hospital of Saint Raphael

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

Relationship of survival to post-treatment peak standardized uptake value (SUV) as determined by the imaging institution

Secondary Outcomes

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