NCT00002622

Talc in Treating Patients With Malignant Pleural Effusion

Official Title:

Sclerosis of Pleural Effusions by Talc Thoracoscopy Versus Talc Slurry: A Phase III Study

Summary

RATIONALE: Talc may relieve malignant pleural effusion. It is not yet known whether wet talc is more effective than dry talc in treating patients with malignant pleural effusion.

PURPOSE: Randomized phase III trial to compare the effectiveness of wet talc with dry talc in treating patients with malignant pleural effusion.

Eligibility

DISEASE CHARACTERISTICS: Unilateral malignant pleural effusion requiring sclerosis (as judged by the attending surgeon) At least 3 months since treatment of contralateral effusion No chylous effusion

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: More than 2 months Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Able to undergo thoracoscopy under general or local anesthesia (as determined by the attending surgeon) Not pregnant Tests and observations must be completed within 1 week prior to randomization (chest x-ray within 1 week prior to procedure)

PRIOR CONCURRENT THERAPY: No prior intrapleural therapy No systemic therapy within 2 weeks prior to randomization or 2 weeks post pleurodesis Biologic therapy: Not specified Chemotherapy: No new systemic chemotherapy for 2 weeks prior to and at least 2 weeks after pleurodesis Endocrine therapy: No new hormonal therapy for 2 weeks prior to and at least 2 weeks after pleurodesis No concurrent steroids used as antiemetics Radiotherapy: Prior radiotherapy allowed No radiotherapy to entire hemithorax Palliative irradiation of symptomatic bone lesions allowed on the affected side if field does not include a significant portion of pleura Surgery: See Disease Characteristics

Disease(s) and\or Condition(s)

Metastatic Cancer

Primary Purpose
  • SUPPORTIVE_CARE
Intervention/Treatment
    • Type: DRUG
    • Name: talc
    • Description: 4 to 5 grams talc in 100 cc saline via chest tube at bedside, one time
    • Arm Group Labels: Talc slurry via chest tube
    • Type: DRUG
    • Name: Talc
    • Description: 4 to 5 grams talc via insufflation through direct or video thoracoscopy, one time
    • Arm Group Labels: Talc via insufflation
Sponsor
  • Alliance for Clinical Trials in Oncology