Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00042770
Status:
COMPLETED
Last Update Posted:
2016-07-04
First Post:
2002-08-05
Brief Title:
Standard Chest Tube Compared With a Small Catheter in Treating Malignant Pleural Effusion in Patients With Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Phase III Comparison of Catheter Based Therapy of Pleural Effusions in Cancer Patients Optimal Pleural Effusion Control OPEC
Status:
COMPLETED
Status Verified Date:
2016-07
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 It is not yet known whether pleurodesis using a chest tube with infusions of talc is more effective in improving quality of life than pleurodesis using a small catheter in treating malignant pleural effusion
PURPOSE Randomized phase III trial to compare the effectiveness of a chest tube and talc with that of a small catheter in treating malignant pleural effusion in patients who have cancer
PURPOSE Randomized phase III trial to compare the effectiveness of a chest tube and talc with that of a small catheter in treating malignant pleural effusion in patients who have cancer
Detailed Description:
OBJECTIVES
Compare the success rate in patients with cancer who undergo pleurodesis using a standard chest tube with talc slurry vs a small PleurX catheter for the treatment of a symptomatic unilateral malignant pleural effusion
Compare the 30-day effusion control rate in patients treated with these procedures
Compare quality of life in these patients at 7-14 and 30-37 days after treatment with these procedures
Compare patient acceptance and satisfaction after treatment with these procedures
Compare the level of symptoms and dyspnea experienced by patients treated with these procedures
Compare the types causes and rates of early technical failures of these procedures in these patients
Compare the 30-day effusion recurrences in patients treated with these procedures
Compare the 60-day durability of pleurodesis in patients treated with these procedures
Compare the mortality morbidity and common surgical complications in patients treated with these procedures
OUTLINE This is a randomized multicenter study Patients are stratified according to inpatient status yes vs no disease type breast vs lung vs other and concurrent systemic chemotherapy yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo placement of a standard pleural chest tube Within 36 hours of chest tube placement patients undergo pleurodesis comprising intrapleural administration of talc slurry once followed by clamping of the chest tube for 2 hours while different patient positions are used to distribute the talc The chest tube is then unclamped to allow continuous drainage When the chest tube drainage is less than 150 mL over 24 hours pleurodesis is assumed and the chest tube is removed
Arm II Patients undergo pleurodesis comprising placement of a small PleurX catheter followed by pleural drainage for up to 90 minutes once daily When the catheter drainage is less than 30 mL per day for 3 consecutive days pleurodesis is assumed and the catheter is removed
Quality of life and dyspnea are assessed at baseline and then at 7-14 and 30-37 days after treatment
Patients are followed at 30 and 60 days
Compare the success rate in patients with cancer who undergo pleurodesis using a standard chest tube with talc slurry vs a small PleurX catheter for the treatment of a symptomatic unilateral malignant pleural effusion
Compare the 30-day effusion control rate in patients treated with these procedures
Compare quality of life in these patients at 7-14 and 30-37 days after treatment with these procedures
Compare patient acceptance and satisfaction after treatment with these procedures
Compare the level of symptoms and dyspnea experienced by patients treated with these procedures
Compare the types causes and rates of early technical failures of these procedures in these patients
Compare the 30-day effusion recurrences in patients treated with these procedures
Compare the 60-day durability of pleurodesis in patients treated with these procedures
Compare the mortality morbidity and common surgical complications in patients treated with these procedures
OUTLINE This is a randomized multicenter study Patients are stratified according to inpatient status yes vs no disease type breast vs lung vs other and concurrent systemic chemotherapy yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo placement of a standard pleural chest tube Within 36 hours of chest tube placement patients undergo pleurodesis comprising intrapleural administration of talc slurry once followed by clamping of the chest tube for 2 hours while different patient positions are used to distribute the talc The chest tube is then unclamped to allow continuous drainage When the chest tube drainage is less than 150 mL over 24 hours pleurodesis is assumed and the chest tube is removed
Arm II Patients undergo pleurodesis comprising placement of a small PleurX catheter followed by pleural drainage for up to 90 minutes once daily When the catheter drainage is less than 30 mL per day for 3 consecutive days pleurodesis is assumed and the catheter is removed
Quality of life and dyspnea are assessed at baseline and then at 7-14 and 30-37 days after treatment
Patients are followed at 30 and 60 days
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 |
|---|---|---|---|
| CDR0000069451 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA076001 |
| U10CA076001 | NIH | None | None |
| CALGB-30102 | None | None | None |