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Phase II Study of Fludeoxyglucose F18 Positron Emission Tomography for Pre- and Post-treatment Assessment in Patients With Locally Advanced Non-Small Cell Lung Cancer
Alternate Title Fludeoxyglucose F18 Positron Emission Tomography Imaging In Assessing Patients Before and After Treatment for Locally Advanced Non-Small Cell Lung Cancer
Objectives Primary
Secondary
Entry Criteria Disease Characteristics:
Prior/Concurrent Therapy: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Patient Characteristics: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
Expected Enrollment 250A 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. Outcomes Primary Outcome(s)Relationship of survival to post-treatment peak standardized uptake value (SUV) as determined by the imaging institution Relationship of survival to post-treatment max SUV as determined by the imaging institute 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. Trial Lead Organizations American College of Radiology Imaging Network
Radiation Therapy Oncology Group
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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