Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002622
Status:
COMPLETED
Last Update Posted:
2016-06-28
First Post:
1999-11-01
Brief Title:
Talc in Treating Patients With Malignant Pleural Effusion
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Sclerosis of Pleural Effusions by Talc Thoracoscopy Versus Talc Slurry A Phase III Study
Status:
COMPLETED
Status Verified Date:
2016-06
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 Talc may relieve malignant pleural effusion It is not yet known whether wet talc is more effective than dry talc in treating patients with malignant pleural effusion
PURPOSE Randomized phase III trial to compare the effectiveness of wet talc with dry talc in treating patients with malignant pleural effusion
PURPOSE Randomized phase III trial to compare the effectiveness of wet talc with dry talc in treating patients with malignant pleural effusion
Detailed Description:
OBJECTIVES I Compare the proportion of patients with successful pleurodesis at 30 days following treatment for malignant pleural effusion MPE by talc slurry via chest tube vs thoracoscopic talc insufflation II Compare the cost and cost effectiveness of both treatments for MPE III Compare the time to recurrence of effusion duration of chest tube drainage after sclerosis extent of postinstillation complications and toxicities and the ability to re-expand the lung in patients randomized to these 2 treatments IV Evaluate the quality of life and pain experienced by patients during both treatments
OUTLINE This is a randomized study Patients are stratified according to participating institution Patients are randomized to one of two treatment arms Arm I Patients undergo pleurodesis A chest tube is inserted the pleural fluid is drained for 24 hours and the lung is re-expanded to at least 90 of full expansion Within 24-36 hours patients undergo sclerosis with talc slurry injected into the chest tube which is then clamped Patients are rotated in all possible directions holding each position for about 30 minutes After 2 hours the chest tube is unclamped and reattached to suction drainage which is strictly measured for 24-hour totals Following a decrease in drainage to no more than 150 ml24 hours usually by the second or third day postsclerosis the chest tube is removed Arm II Patients receive thoracoscopic insufflation The chest is explored thoracoscopically via single or multiple incisions using direct or videothoracoscopic visualization and the lung is re-expanded to 90 of full expansion Dry talc is pneumatically insufflated into the chest with complete dispersion throughout the hemithorax Following insufflation the chest is drained via a chest tube which is removed when the drainage is no more than 150 ml24 hours usually by day 2 or 3 following insufflation Patients are removed from study for disease progression or an unsuccessful lung re-expansion Patients are followed monthly for 6 months for relapse and survival
PROJECTED ACCRUAL Approximately 500 patients will be accrued for this study over 28 months
OUTLINE This is a randomized study Patients are stratified according to participating institution Patients are randomized to one of two treatment arms Arm I Patients undergo pleurodesis A chest tube is inserted the pleural fluid is drained for 24 hours and the lung is re-expanded to at least 90 of full expansion Within 24-36 hours patients undergo sclerosis with talc slurry injected into the chest tube which is then clamped Patients are rotated in all possible directions holding each position for about 30 minutes After 2 hours the chest tube is unclamped and reattached to suction drainage which is strictly measured for 24-hour totals Following a decrease in drainage to no more than 150 ml24 hours usually by the second or third day postsclerosis the chest tube is removed Arm II Patients receive thoracoscopic insufflation The chest is explored thoracoscopically via single or multiple incisions using direct or videothoracoscopic visualization and the lung is re-expanded to 90 of full expansion Dry talc is pneumatically insufflated into the chest with complete dispersion throughout the hemithorax Following insufflation the chest is drained via a chest tube which is removed when the drainage is no more than 150 ml24 hours usually by day 2 or 3 following insufflation Patients are removed from study for disease progression or an unsuccessful lung re-expansion Patients are followed monthly for 6 months for relapse and survival
PROJECTED ACCRUAL Approximately 500 patients will be accrued for this study over 28 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 |
|---|---|---|---|
| CDR0000063982 | REGISTRY | NCI Physician Desk Reference | httpsreporternihgovquickSearchU10CA031946 |
| U10CA031946 | NIH | None | None |
| CLB-9334 | None | None | None |
| E-C9334 | None | None | None |
| NCCTG-C9334 | None | None | None |
| RTOG-9511 | None | None | None |