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

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.