Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
In this trial, the effect of intrapleural docetaxel administration using medical pleuroscopywill be evaluated in Lung Cancer patient with malignant effusion.
This study is designed to be pilot, single-center, open-label, single-arm, prospective, phase II trial of patient with NSCLC with pleurla effusion. Approximately 40 patients will be enrolled into the trial, and study will be performed to 31Dec2018 from IRB and Korea: MFDS approval date.
Docetaxel will be administed to interpleural space using medical pleuroscopy in malignant effusion with lung cancer. Response evaluation will be done until confiramtion of disease progression.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intrapleural docetaxel administration | Experimental | Docetaxel will be administed to interpleural space using medical pleuroscopy in malignant effusion with lung cancer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intrapleural docetaxel administration | Drug | intrapleural docetaxel administration using medical pleuroscopy in malignant effusion with lung cancer |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall respose rate(ORR) | Rate of CR and PR | through study completion (2.5 years) |
| Complete resonse (CR) rate | through study completion (2.5 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to progression(TTP) | time from the date of the start of treatment until the disease progression or death. | through study completion (2.5 years) |
| Overall survival(OS) | time fromthe date of the start of treatment to death or the date of last follow-up |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| CHANG-MIN CHOI, MD, PhD | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D016066 | Pleural Effusion, Malignant |
| ID | Term |
|---|---|
| D010997 | Pleural Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| through study completion (2.5 years) |
| Adverse Event | Based on National Cancer Institute Common Toxicity Criteria | through study completion (2.5 years) |
| D009369 |
| Neoplasms |
| D010996 | Pleural Effusion |
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |