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| Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) Eastern Cooperative Oncology Group Radiation Therapy Oncology Group North Central Cancer Treatment Group |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002622 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Cancer |
Drug: talc |
Phase III |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Randomized |
| Official Title: | SCLEROSIS OF PLEURAL EFFUSIONS BY TALC THORACOSCOPY VERSUS TALC SLURRY: A PHASE III STUDY |
| Estimated Enrollment: | 500 |
| Study Start Date: | December 1994 |
OBJECTIVES: I. Compare the proportion of patients with successful pleurodesis at 30 days following treatment for malignant pleural effusion (MPE) by talc slurry via chest tube vs thoracoscopic talc insufflation. II. Compare the cost and cost effectiveness of both treatments for MPE. III. Compare the time to recurrence of effusion, duration of chest tube drainage after sclerosis, extent of postinstillation complications and toxicities, and the ability to re-expand the lung in patients randomized to these 2 treatments. IV. Evaluate the quality of life and pain experienced by patients during both treatments.
OUTLINE: This is a randomized study. Patients are stratified according to participating institution. Patients are randomized to one of two treatment arms. Arm I: Patients undergo pleurodesis. A chest tube is inserted, the pleural fluid is drained for 24 hours, and the lung is re-expanded to at least 90% of full expansion. Within 24-36 hours patients undergo sclerosis with talc slurry injected into the chest tube, which is then clamped. Patients are rotated in all possible directions, holding each position for about 30 minutes. After 2 hours the chest tube is unclamped and reattached to suction drainage, which is strictly measured for 24-hour totals. Following a decrease in drainage to no more than 150 ml/24 hours (usually by the second or third day postsclerosis), the chest tube is removed. Arm II: Patients receive thoracoscopic insufflation. The chest is explored thoracoscopically via single or multiple incisions using direct or videothoracoscopic visualization, and the lung is re-expanded to 90% of full expansion. Dry talc is pneumatically insufflated into the chest, with complete dispersion throughout the hemithorax. Following insufflation, the chest is drained via a chest tube, which is removed when the drainage is no more than 150 ml/24 hours (usually by day 2 or 3 following insufflation). Patients are removed from study for disease progression or an unsuccessful lung re-expansion. Patients are followed monthly for 6 months for relapse and survival.
PROJECTED ACCRUAL: Approximately 500 patients will be accrued for this study over 28 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Show 241 Study Locations| Study Chair: | Jemi Olak, MD | Kern Medical Center |
| Study Chair: | Thomas M. Daniel, MD | University of Virginia |
| Study Chair: | George B. Haasler, MD | Froedtert Hospital and Medical College of Wisconsin |
| Study Chair: | Mark S. Allen, MD | Mayo Clinic |
More Information
| Study ID Numbers: | CDR0000063982, CLB-9334, E-C9334, NCCTG-C9334, RTOG-9511 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00002622 |
| Health Authority: | United States: Federal Government |
|
malignant pleural effusion |
|
Thoracic Neoplasms Pleural Effusion Respiratory Tract Diseases Pleural Diseases |
Neoplasm Metastasis Pleural Effusion, Malignant Sclerosis Pleural Neoplasms |
|
Respiratory Tract Neoplasms Neoplasms Neoplastic Processes Neoplasms by Site Pathologic Processes |
