Sclerosis of pleural effusions by talc thoracoscopy versus talc slurry: A Phase III study

Originating Group

CALGB 9334

Co-P.I.: Dr. J. Olak

and Dr. C. Dresler

Participating Groups

RTOG #95-11 Dr. George B. Haasler
NCCTG #C9334 Dr. Mark S. Allen
ECOG #C9334 Dr. Thomas M. Daniel

Objectives

  1. To compare the proportion of patients with successful pleurodesis at 30 days after treatment for malignant pleural effusion (MPE) by talc slurry via chest tube or thoracoscopic talc insufflation
  2. To compare the cost and cost-effectiveness of treating patients for MPE by talc slurry via chest tube to thoracoscopic talc insufflation
  3. To compare the treatments with respect to the time to recurrence ofthe effusion, duration of chest tube drainage after sclerosis, extent of post-instillation complications and toxicities, ability to re-expand the lung, quality of life and pain experienced during treatment.

Eligibility

  1. History of malignant disease
  2. Pleural effusion requiring sclerosis
  3. Ability to undergo thoracoscopy under general anesthesia
  4. Performance status 0-2
  5. Age > 18 years and life expectancy >2 months
  6. No prior intrapleural therapy
  7. No chance in systemic therapy within 2 weeks
  8. No significantirradiation to affected hemithorax
  9. Unilateral non-chylous effusion

Schema

Comments

activated - 12/94
closure date - 9/99
current accrual - 500 patients as of 9/30/99
accrual target increased due to a higher than expected percentage of deaths within 30 days and non-reexpansion
POSTER presented at ASCO, 2000

*open only to credentialled surgeons