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
  Purpose

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.


Condition Intervention Phase
Metastatic Cancer
Pulmonary Complications
Other: talc
Procedure: dyspnea management
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Comparison of Catheter Based Therapy of Pleural Effusions in Cancer Patients (Optimal Pleural Effusion Control, OPEC)

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Effusion control [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of Life [ Time Frame: 7-14 days and 30-37 days ] [ Designated as safety issue: No ]

Enrollment: 67
Study Start Date: May 2002
Study Completion Date: February 2008
Primary Completion Date: February 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other: talc
Given intrapleurally
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.
Procedure: dyspnea management
No talc

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.

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00042770

Locations
United States, California
Providence Saint Joseph Medical Center - Burbank
Burbank, California, United States, 91505
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
Investigators
Study Chair: Todd L. Demmy, MD Roswell Park Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00042770     History of Changes
Other Study ID Numbers: CDR0000069451, U10CA076001, CALGB-30102
Study First Received: August 5, 2002
Last Updated: September 26, 2013
Health Authority: United States: Federal Government

Keywords provided by Alliance for Clinical Trials in Oncology:
malignant pleural effusion
pulmonary complications

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Pleural Effusion
Pleural Effusion, Malignant
Neoplastic Processes
Pathologic Processes
Pleural Diseases
Respiratory Tract Diseases
Pleural Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on August 27, 2014