Dry Pleurodesis With Talcum and Afatinib is Used to Treat... | NCT03827070

Studies
Dry Pleurodesis With Talcum and Afatinib is Used to Treat Patients With Non-Small Cell Lung Carcinoma

NCT03827070

Sponsor

Center Trials & Treatment Europe

Status

Unknown status

Last Update Posted

Apr 25, 2023Actual

Enrollment

12Actual

Phase

Phase 1

Conditions

Non Small Cell Lung Cancer

Interventions

Afatinib
Talcum powder

Countries

Georgia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 5, 2019Actual

Primary Completion Date

Feb 21, 2023Actual

Completion Date

Jul 21, 2023Estimated

First Submitted Date

Jan 29, 2019

First Submission Date that Met QC Criteria

Jan 30, 2019

First Posted Date

Feb 1, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 23, 2023

Last Update Posted Date

Apr 25, 2023Actual

Name	Class
Center Trials & Treatment	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

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%.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Talcum powder & Afatinib	Experimental	Talcum powder 4 g + Afatinib 0,4 g. Is entered once	Drug: Afatinib Drug: Talcum powder

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Afatinib	Drug	Used Afatinib particles of which had an average size of 22 μm and a volume concentration of small particles (<5 μm) - only 19%	Talcum powder & Afatinib

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The effectiveness of the procedure of dry pleurodesis through a thoracoscope	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.	up to 90 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Non-small cell lung cancer with positive mutation of EGFR verified
Malignant pleural effusion
Recurrent pleural effusion
Complete lung expansion (> 80%) after puncture emptying confirmed by chest radiography.
Karnofsky index > 50
Agreed to participate in the study and sign an Informed Consent

Exclusion Criteria:

Radiotherapy not earlier than 3 months before the pleurodesis procedure
Previous surgeries on the same hemitorace
Thrombocytopenia or coagulation disorders
Trapped lung syndrome
Patients with estimated life expectancy < 4-8 weeks
Pleural or active systemic infection

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Central Contact		Tbilisi		0008	Georgia

Condition Browse Module

MeSH Terms

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077716	Afatinib
D013627	Talc

Ancestor Terms

ID	Term
D000577	Amides
D009930	Organic Chemicals
D011799	Quinazolines
D006574	Heterocyclic Compounds, 2-Ring

Browse Leaves

Not provided

Browse Branches

Not provided