Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00055965
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
2003-03-06
Brief Title:
Hospitalization Rates of Patients With Non-Small Cell Lung Cancer Treated With Gemcitabine and Either Cisplatin or Carboplatin
Sponsor:
The Christie NHS Foundation Trust
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Pragmatic Randomised Study To Compare The Hospitalisation Rates Of Two Platinum-Based Outpatient Regimens GemcitabineCisplatin vs GemcitabineCarboplatin In Non-Small Cell Lung Cancer NSCLC
Status:
UNKNOWN
Status Verified Date:
2009-01
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:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells It is not yet known if one regimen will require patients to spend more time in the hospital than the other regimen for treatment of chemotherapy-related side effects
PURPOSE Randomized phase III trial to compare the hospitalization rates of patients who are receiving gemcitabine combined with cisplatin with that of patients receiving gemcitabine combined with carboplatin for unresectable stage III or stage IV non-small cell lung cancer
PURPOSE Randomized phase III trial to compare the hospitalization rates of patients who are receiving gemcitabine combined with cisplatin with that of patients receiving gemcitabine combined with carboplatin for unresectable stage III or stage IV non-small cell lung cancer
Detailed Description:
OBJECTIVES
Compare the rates of overnight hospitalization due to toxicity eg blood transfusion antibiotic use and to obtain relief of treatment-related symptoms of patients with non-small cell lung cancer treated with gemcitabine and cisplatin vs gemcitabine and carboplatin
Compare the need for hospitalization for chemotherapy administration in patients treated with these regimens
Compare the tumor response rate of patients treated with these regimens
Compare the overall survival of patients treated with these regimens
Compare the relief of tumor-related symptoms in patients treated with these regimens
Compare the effect on Karnofsky performance status in patients treated with these regimens
Compare the toxic effects of these regimens in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to stage IIIA vs IIIB dry vs IIIB wet or IV and performance status 50-60 vs 70-100 Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive gemcitabine IV over 30 minutes and cisplatin IV over 1-2 hours on days 1 and 8
Arm II Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin IV over 30-60 minutes on day 1
In both arms treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 2 months for 6 months and then every 3-4 months thereafter
PROJECTED ACCRUAL A total of 400 patients 200 per treatment arm will be accrued for this study
Compare the rates of overnight hospitalization due to toxicity eg blood transfusion antibiotic use and to obtain relief of treatment-related symptoms of patients with non-small cell lung cancer treated with gemcitabine and cisplatin vs gemcitabine and carboplatin
Compare the need for hospitalization for chemotherapy administration in patients treated with these regimens
Compare the tumor response rate of patients treated with these regimens
Compare the overall survival of patients treated with these regimens
Compare the relief of tumor-related symptoms in patients treated with these regimens
Compare the effect on Karnofsky performance status in patients treated with these regimens
Compare the toxic effects of these regimens in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to stage IIIA vs IIIB dry vs IIIB wet or IV and performance status 50-60 vs 70-100 Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive gemcitabine IV over 30 minutes and cisplatin IV over 1-2 hours on days 1 and 8
Arm II Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin IV over 30-60 minutes on day 1
In both arms treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 2 months for 6 months and then every 3-4 months thereafter
PROJECTED ACCRUAL A total of 400 patients 200 per treatment arm will be accrued for this study
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-20245 | None | None | None |
| CHNT-GEM-HOSP | None | None | None |