Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002872
Status:
COMPLETED
Last Update Posted:
2023-06-22
First Post:
1999-11-01
Brief Title:
Bleomycin Doxycycline or Talc in Treating Patients With Malignant Pleural Effusions
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
A PROSPECTIVE RANDOMIZED TRIAL OF BLEOMYCIN VS DOXYCYCLINE VS TALC FOR THE INTRAPLEURAL TREATMENT OF MALIGNANT PLEURAL EFFUSIONS
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
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 Some drugs such as bleomycin or doxycycline or other compounds like talc may help to control fluid in the chest caused by cancer It is not yet known if bleomycin doxycycline or talc is more effective in treating patients with malignant pleural effusions
PURPOSE Randomized phase III trial to compare the effectiveness of bleomycin doxycycline or talc in treating patients with malignant pleural effusions
PURPOSE Randomized phase III trial to compare the effectiveness of bleomycin doxycycline or talc in treating patients with malignant pleural effusions
Detailed Description:
OBJECTIVES I Compare intrapleural bleomycin vs doxycycline vs talc in the treatment of malignant pleural effusion with respect to time to recurrence of the effusion II Compare these treatments with respect to the necessity for further treatment of recurrent effusions III Compare these treatments with respect to the extent of postinfusion complications including pain and dyspnea IV Compare these treatments with respect to duration of chest tube or soft catheter drainage required following pleurodesis V Compare these treatments with respect to duration of hospitalization for retreatment of malignant pleural effusion following recurrence VI Compare these treatments with respect to survival VII Compare these treatments with respect to the impact of the procedure on pain and dyspnea
OUTLINE This is a randomized trial Patients are stratified by type of drainage device and participating institution All patients are randomized to undergo pleurodesis with bleomycin doxycycline or talc by indwelling pleural catheter A second procedure is undertaken 72 hours later if pleural drainage is persistently large Patients are followed monthly for survival
PROJECTED ACCRUAL A total of 480 patients will be entered over 48 months
OUTLINE This is a randomized trial Patients are stratified by type of drainage device and participating institution All patients are randomized to undergo pleurodesis with bleomycin doxycycline or talc by indwelling pleural catheter A second procedure is undertaken 72 hours later if pleural drainage is persistently large Patients are followed monthly for survival
PROJECTED ACCRUAL A total of 480 patients will be entered over 48 months
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 |
|---|---|---|---|
| NCI-P96-0076 | None | None | None |
| E-8592 | None | None | None |
| NCCTG-942853 | None | None | None |