Phase III Comparison of Catheter Based Therapy of Pleural Effusions in Cancer Patients (Optimal Pleural Effusion Control, OPEC)
18 Years
N/A
Both
Neoplasm Metastasis, Pulmonary Complications
Trial Information
Phase III Comparison of Catheter Based Therapy of Pleural Effusions in Cancer Patients (Optimal Pleural Effusion Control, OPEC)
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Effusion control
Outcome Time Frame:
30 days
Safety Issue:
No
Principal Investigator
Todd L. Demmy, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Roswell Park Cancer Institute
Authority:
United States: Federal Government
Study ID:
CDR0000069451
NCT ID:
NCT00042770
Start Date:
May 2002
Completion Date:
February 2008
Related Keywords:
- Neoplasm Metastasis
- Pulmonary Complications
- malignant pleural effusion
- pulmonary complications
- Neoplasms
- Neoplasm Metastasis
- Pleural Effusion
- Pleural Effusion, Malignant
Name | Location |
|---|---|
| Providence Saint Joseph Medical Center - Burbank | Burbank, California 91505 |
