Clinical trial · Interventional
Talc in Treating Patients With Malignant Pleural Effusion
Sclerosis of Pleural Effusions by Talc Thoracoscopy Versus Talc Slurry: A Phase III Study
NCT00002622CI-TRIAL-00022750completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| talc | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Talc slurry via chest tube
- description
- talc slurry via chest tube
- interventionNames
- Drug: talc
- type
- ACTIVE_COMPARATOR
- label
- Talc via insufflation
- description
- 4 to 5 grams talc via insufflation through direct or videoscopic thoracoscopy, one time
- interventionNames
- Drug: Talc
Primary outcomes (2)
- measure
- Successful pleurodesis
- timeFrame
- 30 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (3)
- RESULTDresler CM, Olak J, Herndon JE 2nd, Richards WG, Scalzetti E, Fleishman SB, Kernstine KH, Demmy T, Jablons DM, Kohman L, Daniel TM, Haasler GB, Sugarbaker DJ; Cooperative Groups Cancer and Leukemia Group B; Eastern Cooperative Oncology Group; North Central Cooperative Oncology Group; Radiation Therapy Oncology Group. Phase III intergroup study of talc poudrage vs talc slurry sclerosis for malignant pleural effusion. Chest. 2005 Mar;127(3):909-15. doi: 10.1378/chest.127.3.909. PMID 15764775
- RESULTFleishman SB, Dresler C, Herndon JE, et al.: Quality of life (QOL) advantage of sclerosis for malignant pleural effusion (MPE) via talc thoracoscopy over chest tube infusion of talc slurry: a cancer and leukemia group B study. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1418, 2002.
- RESULTDresler CM, Herndon JE, Daniels T, et al.: Cancer and Leukemia Group B (CALGB) 9334: a phase III, intergroup study of sclerosis of malignant pleural effusion by talc. [Abstract] Proceedings of the American Society of Clinical Oncology 19: A2455, 2000.