Fludeoxyglucose F18 Positron Emission Tomography Imaging In Assessing Patients Before and After Treatment for Locally Advanced Non-Small Cell Lung Cancer
Recruitment status was Active, not recruiting
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.
Drug: vinblastine sulfate
Drug: vinorelbine tartrate
Genetic: gene expression analysis
Procedure: positron emission tomography
Radiation: fludeoxyglucose F 18
Radiation: radiation therapy
|Study Design:||Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Positron Emission Tomography Pre- and Post-treatment Assessment For Locally Advanced Non-Small Cell Lung Carcinoma|
- Relationship of survival to post-treatment peak standardized uptake value (SUV) as determined by the imaging institution [ Designated as safety issue: No ]
- Relationship of survival to post-treatment max SUV as determined by the imaging institute [ Designated as safety issue: No ]
- Relationship of local control to post-treatment peak and max SUV as determined by the imaging institution [ Designated as safety issue: No ]
- Relationship of survival and of local control to pre-treatment peak and max SUV as determined by the imaging institution [ Designated as safety issue: No ]
- Reliability between peak and max SUV measurements both pre- and post-treatment [ Designated as safety issue: No ]
- Proportion of participants who are either upstaged or downstaged by positron emission tomography scan [ Designated as safety issue: No ]
- Reliability between PET scan-defined response to therapy measurements [ Designated as safety issue: No ]
- Correlation of Ki-67 expression with peak and max pre-treatment SUV [ Designated as safety issue: No ]
- Association between Ki-67 expression and overall survival at 2 years [ Designated as safety issue: No ]
|Study Start Date:||March 2005|
|Estimated Primary Completion Date:||June 2006 (Final data collection date for primary outcome measure)|
- 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.
- 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.
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|Study Chair:||Mitchell Machtay, MD||Kimmel Cancer Center (KCC)|