Carcinoma, Non-Small-Cell Lung
Conditions
Keywords
Lung, Chemotherapy, Cisplatin, Intratumoral, Bronchoscope, Brachytherapy
Brief summary
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
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.
Interventions
DRUGCisplatin
1 mg/ml at a dosage of approximately 2 mg per cubic cm of tumor. Weekly up to 6 injections.
Sponsors
Southwestern Regional Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Respiratory symptoms due to occlusion to be assessed both before and after the procedure. | 3 years |
Countries
United States
Outcome results
None listed