Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00112710
Status:
UNKNOWN
Last Update Posted:
2013-08-26
First Post:
2005-06-02
Brief Title:
Gemcitabine in Combination With Either Cisplatin or Carboplatin in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
Sponsor:
University Hospital Birmingham
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A British Thoracic Oncology Group Phase III Trial of Gemcitabine Plus Cisplatin at 80mgm Versus Gemcitabine Plus Carboplatin At 50 mgm Versus Gemcitabine Plus Carboplatin AUC 6 in Stage IIIBIV Non-Small Cell Lung Cancer NSCLC
Status:
UNKNOWN
Status Verified Date:
2007-05
Last Known Status:
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:
None
Brief Summary:
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
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
Detailed Description:
OBJECTIVES
Primary
Compare the efficacy of gemcitabine in combination with 2 different doses of cisplatin vs carboplatin in terms of survival time in patients with stage IIIB or IV non-small cell lung cancer
Secondary
Compare symptom control and quality of life of patients treated with these regimens
Compare response in patients treated with these regimens
Compare the dose intensity of these regimens in these patients
Compare the ratio of courses of treatment given as in-patient vs out-patient in these patients
Compare the intensity and number and duration of toxic episodes in patients treated with these regimens
Compare cost and cost-effectiveness of these regimens in these patients
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
Arm I Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and cisplatin IV over 1 hour on day 1
Arm II Patients receive gemcitabine as in arm I and cisplatin at a lower dose than in arm I IV over 1 hour on day 1
Arm III Patients receive gemcitabine as in arm I and carboplatin IV over 1 hour on day 1
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 1350 patients 450 per treatment arm will be accrued for this study within 6 years
Primary
Compare the efficacy of gemcitabine in combination with 2 different doses of cisplatin vs carboplatin in terms of survival time in patients with stage IIIB or IV non-small cell lung cancer
Secondary
Compare symptom control and quality of life of patients treated with these regimens
Compare response in patients treated with these regimens
Compare the dose intensity of these regimens in these patients
Compare the ratio of courses of treatment given as in-patient vs out-patient in these patients
Compare the intensity and number and duration of toxic episodes in patients treated with these regimens
Compare cost and cost-effectiveness of these regimens in these patients
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
Arm I Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and cisplatin IV over 1 hour on day 1
Arm II Patients receive gemcitabine as in arm I and cisplatin at a lower dose than in arm I IV over 1 hour on day 1
Arm III Patients receive gemcitabine as in arm I and carboplatin IV over 1 hour on day 1
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 1350 patients 450 per treatment arm will be accrued for this study within 6 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-20510 | None | None | None |
| CRUK-BTOG2-LU3005 | None | None | None |