Standard Chest Tube Compared With a Small Catheter in Treating Malignant Pleural Effusion in Patients With Cancer

NCT00042770 | Completed Phase 3 DMC

• 3 other identifiers: CALGB-30102U10CA076001CDR0000069451
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Cancer; Pulmonary Complications

Keywords

malignant pleural effusion; pulmonary complications

Outcome Measures

Primary Outcomes (1)

• Effusion control

  30 days

Secondary Outcomes (1)

• Quality of Life

  7-14 days and 30-37 days

Study Arms (2)

Arm I

ACTIVE COMPARATOR

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.

Other: talc

Arm II

EXPERIMENTAL

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.

Procedure: dyspnea management

Interventions

talc OTHER

Given intrapleurally

Arm I

dyspnea management PROCEDURE

No talc

Arm II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Radiologic evidence of a unilateral malignant pleural effusion requiring sclerosis or ongoing drainage because it is symptomatic (dyspnea and/or progressive fatigue) * An asymptomatic patient is eligible if the patient underwent a prior thoracentesis within the past 2 weeks and was symptomatic before the procedure * No bilateral effusions by plain chest x-ray * Histologically or cytologically confirmed solid tumor or hematologic malignancy * Histologic confirmation of malignant cells in pleural fluid is not required * Pleural spaces must be naive to pleurodesis attempts * No prior intrapleural therapy (defined as a chest tube in place or placed to drain an effusion, prior surgical pleurectomy, or any prior chemical or mechanical pleurodesis on the ipsilateral side) * Placement of a small interventional radiology catheter for temporary drainage is not considered intrapleural therapy as long as no sclerosant medication was given and it has not been in place longer than 10 days PATIENT CHARACTERISTICS: Age * 18 and over Performance status * CTC 0-2 Hematopoietic * Granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Pulmonary * No active pleural infection Other * No allergy to talc * No surgical contraindication to talc usage * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Chemotherapy * Concurrent systemic chemotherapy allowed Radiotherapy * Concurrent palliative radiotherapy to a symptomatic lesion allowed except to the treated hemithorax within 30 days of the drainage procedure Surgery * See Disease Characteristics * Prior thoracotomies without specific pleural ablation (including lobectomy but not pneumonectomy) allowed * Prior needle-based diagnostic interventions (fine-needle aspiration, small bore catheter drainage of less than 10 days, or thoracentesis) allowed

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Providence Saint Joseph Medical Center - Burbank

Burbank, California, 91505, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis; Pleural Effusion, Malignant

Interventions

Talc

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pleural Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Effusion; Pleural Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Magnesium Silicates; Magnesium Compounds; Inorganic Chemicals; Silicates; Minerals; Silicic Acid; Silicon Dioxide; Silicon Compounds

Study Officials

• Todd Demmy, MD

  Roswell Park Cancer Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2002
• First Posted: January 27, 2003
• Study Start: May 1, 2002
• Primary Completion: February 1, 2005
• Study Completion: February 1, 2008
• Last Updated: July 4, 2016

Record last verified: 2016-07

Locations

US (1)