Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00300729
Status:
UNKNOWN
Last Update Posted:
2009-06-30
First Post:
2006-03-08
Brief Title:
Effect of Celecoxib on Survival in Patients With Advanced Non-Small Cell Lung Cancer Receiving Chemotherapy
Sponsor:
University Hospital Linkoeping
Organization:
University Hospital Linkoeping
Study Overview
Official Title:
Cox-2-Inhibitor and Chemotherapy in Non-Small Cell Lung Cancer A Prospective Randomized Double-Blind Study
Status:
UNKNOWN
Status Verified Date:
2009-06
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CYCLUS
Brief Summary:
The primary purpose of the study is to investigate if daily treatment with celecoxib an inhibitor of cyclooxygenase-2 can prolong survival in patients with advanced non-small cell lung cancer who receive anticancer chemotherapy as their primary treatment Secondary endpoints of the study are health-related quality of life toxicity cardiovascular events progression-free survival and biological markers VEGF proteomics
Detailed Description:
The study CYCLUS trial CY-cyclooxygenase-2 inhibitor Chemotherapy LUng cancer Survival is a prospective randomized double-blind multicenter trial Patients are randomized to receive celecoxib at a dose of 400 mg bid or placebo Primary endpoint of the trial is survival Secondary endpoints are quality of life progression-free survival toxicity cardiovascular events and biological parameters plasma VEGF and proteomics
The rationale behind the study consists of preclinical observations of antitumor effect of celecoxib in NSCLC Inhibition of angiogenesis and proliferation as well as increased apoptosis has been demonstrated In addition pilot studies have shown that the combination of chemotherapy and celecoxib is feasible No unexpected toxicity has been recorded in such trials Furthermore a randomized study of indomethacin prednisolone or placebo in other types of advanced cancer mainly gastrointestinal showed a survival advantage for patients receiving antiinflammatory treatment
Chemotherapy is given according to the current standard of the participating institution In practice patients will usually receive either carboplatin gemcitabine or carboplatin vinorelbine Treatment duration with chemotherapy is 4 cycles cycle length 3 weeks in the absence of tumour progression or prohibitive toxicity
Treatment with the study drug starts on the first day of cancer chemotherapy Maximum treatment duration is one year Treatment will be stopped earlier in case of objective tumor progression serious toxicity that is considered to be related to the study drug or if the patient wants to stop treatment
The size of the study is based on the hypothesis that celecoxib could prolong median survival by 8 weeks as compared to 75 months in the placebo group With standard statistical requirements type I error 5 type II error 20 the calculated number of patients was 760
The study was supported by the Swedish Lung Cancer Study Group and organized as a multicenter trial with participation of seven university hospitals and six smaller hospitals The number of new cases of NSCLC stage IIIB-IV and performance status 0-2 in Sweden is around 1200year It was expected that 20 of the patients could be included in the study which would make completion possible in three years
The study was opened for randomization on May 31 2006 Recruitment of patients was lower than expected The study was closed for further randomization on May 31 2009 as originally planned 319 patients were included Since maximum duration of treatment with the study drug is one year the code will be broken after May 31 2010 Data analysis is planned to take place in summer and autumn 2010
The rationale behind the study consists of preclinical observations of antitumor effect of celecoxib in NSCLC Inhibition of angiogenesis and proliferation as well as increased apoptosis has been demonstrated In addition pilot studies have shown that the combination of chemotherapy and celecoxib is feasible No unexpected toxicity has been recorded in such trials Furthermore a randomized study of indomethacin prednisolone or placebo in other types of advanced cancer mainly gastrointestinal showed a survival advantage for patients receiving antiinflammatory treatment
Chemotherapy is given according to the current standard of the participating institution In practice patients will usually receive either carboplatin gemcitabine or carboplatin vinorelbine Treatment duration with chemotherapy is 4 cycles cycle length 3 weeks in the absence of tumour progression or prohibitive toxicity
Treatment with the study drug starts on the first day of cancer chemotherapy Maximum treatment duration is one year Treatment will be stopped earlier in case of objective tumor progression serious toxicity that is considered to be related to the study drug or if the patient wants to stop treatment
The size of the study is based on the hypothesis that celecoxib could prolong median survival by 8 weeks as compared to 75 months in the placebo group With standard statistical requirements type I error 5 type II error 20 the calculated number of patients was 760
The study was supported by the Swedish Lung Cancer Study Group and organized as a multicenter trial with participation of seven university hospitals and six smaller hospitals The number of new cases of NSCLC stage IIIB-IV and performance status 0-2 in Sweden is around 1200year It was expected that 20 of the patients could be included in the study which would make completion possible in three years
The study was opened for randomization on May 31 2006 Recruitment of patients was lower than expected The study was closed for further randomization on May 31 2009 as originally planned 319 patients were included Since maximum duration of treatment with the study drug is one year the code will be broken after May 31 2010 Data analysis is planned to take place in summer and autumn 2010
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None