Intratumoral Cancer Chemotherapy Through a Flexible Bronchoscope as an Adjunct to Brachytherapy

Study Overview
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Brief Summary
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This study is being conducted in order to determine if intratumoral chemotherapy will be helpful in the palliation of endobronchial tumors when used in conjunction with endobronchial brachytherapy.

Detailed Description
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Injections of cisplatin are given in conjunction with the brachytherapy procedure. If the direct intratumoral injections result in a decrease in the endobronchial obstructed airways and if the therapy is well tolerated, there will be immediate clinical benefit to this minimally invasive method, the most obvious being an improved quality of life. Approximately 2 mg cisplatin per cubic centimeter of tumor are injected into each tumor through a flexible bronchoscope. A total of four to six injections are administered one week apart. Response to therapy is assessed based on improvement in intraluminal obstruction by tumor, as assessed by endobronchial observation.

Official Title
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Intratumoral Cancer Chemotherapy Through a Flexible Bronchoscope as an Adjunct to Brachytherapy

Conditions
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Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
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* Drug: Cisplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with inoperable lung carcinoma and/or recurrent disease. Patients with symptomatic obstruction. Occlusion or partial occlusion of bronchi. Disease verified via bronchoscopy. Patients with a least one endobronchial tumor, measuring at least 0.5 cm. Patients between ages of 20 and 80 years. Documented informed consent must be obtained. Exclusion Criteria: Patients without diagnosis confirmed by bronchoscopy. Patients with endobronchial tumors measuring less than 0.5 cm. Patients younger than 20 or older than 80 years. Patients who do not sign informed consent form.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cisplatin<br>1 mg/ml at a dosage of approximately 2 mg per cubic cm of tumor. Weekly up to 6 injections. | Drug: Cisplatin<br>* 1 mg/ml at a dosage of approximately 2 mg per cubic cm of tumor. Weekly up to 6 injections.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To affect a faster clearing of the obstruction as compared with initial evaluation, based on the percentage of lumen opened. |  | within 4 to 6 injections | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory symptoms due to occlusion to be assessed both before and after the procedure. |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung, Chemotherapy, Cisplatin, Intratumoral, Bronchoscope, Brachytherapy