Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Supportive care, Treatment	Active	18 and over	NCI	CALGB-30102 NCT00042770

Special Category: CTSU trial

Objectives

1. 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.
2. Compare the 30-day effusion control rate in patients treated with these procedures.
3. Compare quality of life in these patients at 7-14 and 30-37 days after treatment with these procedures.
4. Compare patient acceptance and satisfaction after treatment with these procedures.
5. Compare the level of symptoms and dyspnea experienced by patients treated with these procedures.
6. Compare the types, causes, and rates of early technical failures of these procedures in these patients.
7. Compare the 30-day effusion recurrences in patients treated with these procedures.
8. Compare the 60-day durability of pleurodesis in patients treated with these procedures.
9. Compare the mortality, morbidity, and common surgical complications in patients treated with these procedures.

Entry 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

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

Patient Characteristics:

Age

• 18 and over

Performance status

• CTC 0-2

Life expectancy

• Not specified

Hematopoietic

• Granulocyte count at least 1,500/mm³
• Platelet count at least 100,000/mm³

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

Expected Enrollment

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

Outcomes

Success rate
30-day effusion control rate
Quality of life at 7-14 days and 30-37 days
Patient acceptance and satisfaction after treatment
Level of symptoms and dyspnea
Types, causes, and rates of early technical failure
30-day effusion recurrences
60-day durability of pleurodesis
Mortality, morbidity, and common surgical complications

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.

Trial Contact Information

Trial Lead Organizations

Cancer and Leukemia Group B

Todd Demmy, MD, Protocol chair		Ph: 716-845-5873; 800-685-6825

U.S.A.
California
	Burbank
	Providence Saint Joseph Medical Center - Burbank
		Clinical Trials Office - Providence Saint Joseph Medical Center - Burbank	Ph:  818-847-3220

Registry Information
Official Title		Phase III Comparison of Catheter Based Therapy of Pleural Effusions in Cancer Patients (Optimal Pleural Effusion Control, OPEC)
Trial Start Date		2002-05-15
Registered in ClinicalTrials.gov		NCT00042770
Date Submitted to PDQ		2002-05-28
Information Last Verified		2009-03-25
NCI Grant/Contract Number		CA76001

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