Gemcitabine in Combination With Either Cisplatin or Carboplatin in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
Recruitment status was: Recruiting
|First Received Date ICMJE||June 2, 2005|
|Last Updated Date||August 23, 2013|
|Start Date ICMJE||March 2005|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Length of survival|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00112710 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Gemcitabine in Combination With Either Cisplatin or Carboplatin in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer|
|Official Title ICMJE||A British Thoracic Oncology Group Phase III Trial of Gemcitabine Plus Cisplatin at 80mg/m Versus Gemcitabine Plus Carboplatin At 50 mg/m Versus Gemcitabine Plus Carboplatin AUC 6 in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC)|
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, cisplatin, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether giving gemcitabine together with cisplatin is more effective than giving gemcitabine together with carboplatin in treating non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying gemcitabine and cisplatin to see how well they work compared to gemcitabine and carboplatin in treating patients with stage III or stage IV non-small cell lung cancer.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to WHO performance status (0 vs 1 or 2), disease stage (IIIB vs IV), and participating center. Patients are randomized to 1 of 3 treatment arms.
In all arms, treatment repeats every 21 days for 2 courses. Patients are reassessed after 2 courses. Patients with responding disease or stable disease with symptom improvement receive 2 additional courses of therapy in the absence of disease progression or unacceptable toxicity. Patients with disease progression or stable disease without symptom improvement are removed from the study.
Quality of life is assessed at baseline, on day 1 of courses 2-4, at completion of study treatment, and then monthly for 6 months.
After completion of study treatment, patients are followed monthly for 6 months and then periodically thereafter for survival.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 1,350 patients (450 per treatment arm) will be accrued for this study within 6 years.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 3|
|Study Design ICMJE||Allocation: Randomized
Primary Purpose: Treatment
|Condition ICMJE||Lung Cancer|
|Study Arms||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Unknown status|
|Estimated Enrollment ICMJE||1350|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
PRIOR CONCURRENT THERAPY:
|Ages||18 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United Kingdom|
|Removed Location Countries|
|NCT Number ICMJE||NCT00112710|
|Other Study ID Numbers ICMJE||CDR0000429610
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||University Hospital Birmingham|
|Collaborators ICMJE||Not Provided|
|PRS Account||National Cancer Institute (NCI)|
|Verification Date||May 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP