Fludeoxyglucose F18 Positron Emission Tomography Imaging In Assessing Patients Before and After Treatment for Locally Advanced Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00083083|
Recruitment Status : Unknown
Verified October 2007 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : May 17, 2004
Last Update Posted : March 1, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||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||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Masking:||None (Open Label)|
|Official Title:||Positron Emission Tomography Pre- and Post-treatment Assessment For Locally Advanced Non-Small Cell Lung Carcinoma|
|Study Start Date :||March 2005|
|Estimated Primary Completion Date :||June 2006|
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00083083
|Study Chair:||Mitchell Machtay, MD||Sidney Kimmel Cancer Center at Thomas Jefferson University|