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Standard Chest Tube Compared With a Small Catheter in Treating Malignant Pleural Effusion in Patients With Cancer
This study is ongoing, but not recruiting participants.
First Received: August 5, 2002   Last Updated: August 13, 2009   History of Changes
Sponsor: Cancer and Leukemia Group B
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00042770
  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 III

Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
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:

MedlinePlus related topics: Breathing Problems Cancer
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Success rate [ Designated as safety issue: No ]
  • 30-day effusion control rate [ Designated as safety issue: No ]
  • Quality of life at 7-14 days and 30-37 days [ Designated as safety issue: No ]
  • Patient acceptance and satisfaction after treatment [ Designated as safety issue: No ]
  • Level of symptoms and dyspnea [ Designated as safety issue: No ]
  • Types, causes, and rates of early technical failure [ Designated as safety issue: No ]
  • 30-day effusion recurrences [ Designated as safety issue: No ]
  • 60-day durability of pleurodesis [ Designated as safety issue: No ]
  • Mortality, morbidity, and common surgical complications [ Designated as safety issue: No ]

Study Start Date: May 2002
Arms Assigned Interventions
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
Given intrapleurally
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
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
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
Cancer and Leukemia Group B
National Cancer Institute (NCI)
Investigators
Study Chair: Todd L. Demmy, MD Roswell Park Cancer Institute
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers: CDR0000069451, CALGB-30102
Study First Received: August 5, 2002
Last Updated: August 13, 2009
ClinicalTrials.gov Identifier: NCT00042770     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
malignant pleural effusion
pulmonary complications

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

ClinicalTrials.gov processed this record on November 09, 2009



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