Clinical trial · Interventional
Trial of Drainage With or Without Bleomycin Instillation for Malignant Pericardial Effusion
A Randomized Controlled Trial to Evaluate the Efficacy of Intra-pericardial Instillation of a Sclerosing Agent After Pericardial Drainage in Patients With Malignant Pericardial Effusion Associated With Lung Cancer (JCOG9811)
NCT00132613CI-TRIAL-00024003completedPhase 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)
The purpose of this study is to evaluate the efficacy of pericardial instillation of bleomycin as a sclerosing agent after pericardial drainage for lung cancer-associated malignant pericardial 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 |
|---|---|---|---|
| Malignant Pericardial Effusion | Lung Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Observation alone after pericardial drainage | Procedure | — | UNRESOLVED |
| Pericardial instillation of bleomycin after drainage | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- Procedure/Surgery: Observation alone after pericardial drainage
- interventionNames
- Procedure: Observation alone after pericardial drainage
- type
- EXPERIMENTAL
- label
- 2
- description
- Drug: Pericardial instillation of bleomycin after drainage
- interventionNames
- Drug: Pericardial instillation of bleomycin after drainage
Primary outcomes (1)
- measure
- Survival without pericardial effusion at 2 months
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically documented lung cancer * Clinically stable condition after pericardial drainage for malignant pericardial effusion (not necessary that it be documented by cytology) * Expected to live 6 weeks or longer * Sufficient organ function * Signed informed consent Exclusion Criteria: * Myocardial infarction or unstable angina within 3 months * Constrictive pericarditis * Active pneumonitis * Severe infection or disseminated intravascular coagulation (DIC) * Other severe co-morbidity which could not be relieved with pericardial drainage * Chemotherapy-naive small cell lung cancer
References
Publications (0)
Data not yet available
No reference posted for this study.