Pilot Study for Evaluating the Role of F-18 FLT PET/CT in Therapeutic Decision Making in Non-small Cell Lung Cancer
The objective of this pilot study is to determine whether 18F-FLT PET/CT can predict which patients will have poorer progression free survival and overall survival in advanced Non-small Cell Lung Cancer (NSCLC) after first-line therapy and, therefore, need more aggressive treatment.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||The Role of F-18 FLT PET/CT for Selecting the Patients Who Need Maintenance Treatment After First-line Chemotherapy in Advanced Non-small Cell Lung Cancers|
- overall survival [ Time Frame: from the date of FLT PET/CT to the date of death or last follow-up, assessed up to 1 year ] [ Designated as safety issue: No ]
- time to progression [ Time Frame: from the date of FLT PET/CT to the date of documented progression or last follow-up, assessed up to 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||August 2015|
|Estimated Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
|advanced non-small cell lung cancer||
F-18 FLT PET/CT
Other Name: F-18 FLT PET/CT
Standard therapy for patients with advanced NSCLC is platinum based doublet chemotherapy. Current first-line chemotherapy is usually limited to 4-6 cycles, as prolonging treatment does not result in additional benefit and may often cause further toxicity. Until recently, treatment guidelines recommended withholding administration of later-line systemic anti-cancer treatment until disease progression.
There are several reports suggesting that maintenance therapy following first-line chemotherapy offers improved survival in advance stage patients. This approach involves the administration of an active treatment immediately after first-line chemotherapy, thus maintaining the clinical benefit initially obtained. However, drug related toxicity and costs are of great concern. There may also be patients with less aggressive disease where an immediate transition to maintenance therapy after first-line results in overtreatment.
Therefore, selecting patients who require more aggressive treatment or earlier intervention is necessary.
If FLT PET/CT can discriminate the patients with shorter progression free survival and overall survival in this pilot study, patients could be selected for more aggressive or earlier treatment such as maintenance therapy, and the investigators could expect to prolong survival while reducing the adverse events and costs that will accompany inconsequential therapy with FLT PET/CT.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01619241
|Contact: Woo Hee Choi, MDfirstname.lastname@example.org|
|Korea, Republic of|
|Seoul St.Mary's Hospital||Not yet recruiting|
|Seoul, Korea, Republic of, 137-701|
|Contact: Woo Hee Choi, MD 82-31-249-8494 email@example.com|
|Contact: Hyun Su Choi, MD 82-2-2258-1550 firstname.lastname@example.org|
|Principal Investigator: Ie Ryung Yoo, MD|
|Principal Investigator: Jin Hyoung Kang, MD, PhD|
|Sub-Investigator: Hyun Su Choi, MD|
|Sub-Investigator: Woo Hee Choi, MD|
|Sub-Investigator: Narae Lee, MD|
|Principal Investigator:||Ie Ryung Yoo, MD||Seoul St. Mary's Hospital|
|Principal Investigator:||Jin Hyoung Kang, MD, PhD||Seoul St. Mary's Hospital|