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

Condition(s) targeted: Cancer-Related Problem/Condition; Metastatic Cancer

Intervention: talc (Drug); dyspnea management (Procedure)

Phase: Phase 3

Status: Recruiting

Sponsored by: Cancer and Leukemia Group B

Official(s) and/or principal investigator(s):
Todd L. Demmy, MD, Study Chair, Affiliation: Roswell Park Cancer Institute

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.

Official title: Phase III Comparison of Catheter Based Therapy of Pleural Effusions in Cancer Patients (Optimal Pleural Effusion Control, OPEC)

Study design: Treatment, Randomized, Active Control

Primary outcome:

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

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Providence Saint Joseph Medical Center - Burbank, Burbank, California 91505, United States; Recruiting
Clinical Trials Office - Providence Saint Joseph Medical Cente, Phone: 818-847-3220

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: May 2002
Last updated: October 22, 2008