Positron Emission Tomography Pre- and Post-treatment Assessment For Locally Advanced Non-Small Cell Lung Carcinoma
Data Collection
Lung Diseases+4
+ Lung Neoplasms
+ Neoplasms
Diagnostic Study
Summary
Study start date: March 1, 2005
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.250 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Diagnostic Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 49 locations
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
Birmingham, United StatesSee the locationScottsdale Medical Imaging, Limited
Scottsdale, United StatesUSC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, United StatesRadiological Associates of Sacramento Medical Group at Sutter Cancer Center
Sacramento, United States