Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00042770
First received: August 5, 2002
Last updated: September 26, 2013
Last verified: September 2013

August 5, 2002
September 26, 2013
May 2002
February 2005   (final data collection date for primary outcome measure)
Effusion control [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00042770 on ClinicalTrials.gov Archive Site
Quality of Life [ Time Frame: 7-14 days and 30-37 days ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Standard Chest Tube Compared With a Small Catheter in Treating Malignant Pleural Effusion in Patients With Cancer
Phase III Comparison of Catheter Based Therapy of Pleural Effusions in Cancer Patients (Optimal Pleural Effusion Control, OPEC)

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.

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.

PROJECTED ACCRUAL: A total of 530 patients (265 per treatment arm) will be accrued for this study within 3.5 years.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Metastatic Cancer
  • Pulmonary Complications
  • Other: talc
    Given intrapleurally
  • Procedure: dyspnea management
    No talc
  • Active Comparator: 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.
    Intervention: Other: talc
  • Experimental: 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.
    Intervention: Procedure: dyspnea management
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
67
February 2008
February 2005   (final data collection date for primary outcome measure)

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

Life expectancy

  • Not specified

Hematopoietic

  • Granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic

  • Not specified

Renal

  • Not specified

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:

Biologic therapy

  • Not specified

Chemotherapy

  • Concurrent systemic chemotherapy allowed

Endocrine therapy

  • Not specified

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00042770
CDR0000069451, U10CA076001, CALGB-30102
Yes
Alliance for Clinical Trials in Oncology
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Todd L. Demmy, MD Roswell Park Cancer Institute
Alliance for Clinical Trials in Oncology
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP