Dry Pleurodesis With Talcum and Afatinib is Used to Treat Patients With Non-Small Cell Lung Carcinoma (DPTA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03827070|
Recruitment Status : Active, not recruiting
First Posted : February 1, 2019
Last Update Posted : September 10, 2019
In non-small cell lung cancer and metastases in the pleural cavity, pathological effusion is formed.
Currently, the most common and effective method of obliteration of the pleural cavity is pleurodesis with talcum powder.
Talc, when it surface of the pleura, causes chemical inflammation that leads to the soldering of the lungs and chest wall. As a result, the liquid ceases to accumulate.
The addition of a therapeutic dose of afatinib to talc not only blocks effusion into the pleural cavity, but also reduces tumor and metastatic processes.
|Condition or disease||Intervention/treatment||Phase|
|Non Small Cell Lung Cancer||Drug: Afatinib Drug: Talcum powder||Phase 1|
The proposed procedure for dry pleurodesis consists of one stage.
Talc is introduced into the pleural cavity in several ways:
- Drainage - a tube is inserted into the pleural cavity through a puncture in the chest, and then a pasty talcum is delivered into the cavity, which spreads through the cavity during the change of the patient's body position.
- Talcum powder - under the control of thoracoscopy, dry talc is blown into the pleural cavity of the patient, which allows him to evenly distribute and significantly increases the effectiveness of the procedure.
In this Clinical Trial investigators will use the method of thoracoscopy - the blow in of talcum powder and therapeutic dose of Afatinib. Before injection, a suspension of talc and afatinib is subjected to the procedure of pharmaceutical mixing.
The operation is well tolerated by participants and lasts no more than 30 minutes. The effectiveness of the method is 90%.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||None (Open Label)|
|Official Title:||New Method of Treatment for Thoracoscopy or Bronchoscopy by Suspension of Fine Powder of Talcum and Afatinib is Used in Patients With Positive Mutation of EGFR in Non-Small Cell Lung Carcinoma (NSCLC)|
|Actual Study Start Date :||March 5, 2019|
|Estimated Primary Completion Date :||November 9, 2019|
|Estimated Study Completion Date :||March 20, 2020|
Experimental: Talcum powder & Afatinib
Talcum powder 4 g + Afatinib 0,4 g. Is entered once
Used Afatinib particles of which had an average size of 22 μm and a volume concentration of small particles (<5 μm) - only 19%
Other Name: BIBW2992
Drug: Talcum powder
Used Talcum powder particles of which had an average size of 24.5 μm and a volume concentration of small particles (<5 μm) - only 11%
Other Name: Talc
- The effectiveness of the procedure of dry pleurodesis through a thoracoscope [ Time Frame: up to 90 days ]
Evaluation of the effectiveness of the dry pleurodesis procedure in combination with talc and afatinib with the introduction of a powder suspension through a thoracoscope.
The assessment is performed by CT (computed tomography) of each participant twice: 30 days from the day of the procedure and 90 days later.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03827070
|Tbilisi, Georgia, 0008|