Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00022009
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
2001-08-10
Brief Title:
Gemcitabine Plus Supportive Care in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Sponsor:
The Christie NHS Foundation Trust
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase III Randomized Trial Comparing Two Treatment Schedules Of Gemcitabine In Poor Prognosis Status Patients With Advanced Non-Small Cell Lung Cancer
Status:
UNKNOWN
Status Verified Date:
2002-10
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 Treatment plus supportive care may improve quality of life in patients undergoing cancer treatment
PURPOSE Randomized phase IIIII trial to compare the effect of different gemcitabine regimens plus supportive care on quality of life in patients who have locally advanced or metastatic non-small cell lung cancer
PURPOSE Randomized phase IIIII trial to compare the effect of different gemcitabine regimens plus supportive care on quality of life in patients who have locally advanced or metastatic non-small cell lung cancer
Detailed Description:
OBJECTIVES
Compare quality of life in terms of the degree of symptom palliation and improvements in performance status of patients with locally advanced or metastatic poor prognosis non-small cell lung cancer treated with 2 schedules of gemcitabine combined with best supportive care
Compare the toxicity of these regimens in these patients
Compare the overall survival of patients treated with these regimens
Compare the response rate in patients treated with these regimens
OUTLINE This is a randomized open-label multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive gemcitabine IV over 30 minutes once a week for 3 weeks Treatment continues every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients receive gemcitabine IV over 30 minutes once a week for 2 weeks Treatment continues every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity
Patients on both arms also receive best supportive care Additional courses of gemcitabine may be administered at the discretion of the investigator
Quality of life is assessed at baseline and then after each course of chemotherapy
Patients are followed every 2 months for survival
PROJECTED ACCRUAL A total of 174 patients 87 per treatment arm will be accrued for this study
Compare quality of life in terms of the degree of symptom palliation and improvements in performance status of patients with locally advanced or metastatic poor prognosis non-small cell lung cancer treated with 2 schedules of gemcitabine combined with best supportive care
Compare the toxicity of these regimens in these patients
Compare the overall survival of patients treated with these regimens
Compare the response rate in patients treated with these regimens
OUTLINE This is a randomized open-label multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive gemcitabine IV over 30 minutes once a week for 3 weeks Treatment continues every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients receive gemcitabine IV over 30 minutes once a week for 2 weeks Treatment continues every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity
Patients on both arms also receive best supportive care Additional courses of gemcitabine may be administered at the discretion of the investigator
Quality of life is assessed at baseline and then after each course of chemotherapy
Patients are followed every 2 months for survival
PROJECTED ACCRUAL A total of 174 patients 87 per treatment arm will be accrued for this study
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-20062 | None | None | None |
| CHNT-GEM | None | None | None |