Clinical trial NCT00379665: Intratumoral Cancer Chemotherapy Through a Flexible Bronchoscope as an Adjunct to Brachytherapy
Official title: Intratumoral Cancer Chemotherapy Through a Flexible Bronchoscope as an Adjunct to Brachytherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Lung
Chemotherapy
Cisplatin
Intratumoral
Bronchoscope
Brachytherapy
Lead sponsor: Southwestern Regional Medical Center
Sponsor class: OTHER
First posted: 2006-09-22
Enrollment: 25
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: To affect a faster clearing of the obstruction as compared with initial evaluation, based on the percentage of lumen opened.
timeFrame: within 4 to 6 injections
Secondary outcomes:
measure: Respiratory symptoms due to occlusion to be assessed both before and after the procedure.
timeFrame: 3 years
Other outcomes:
Locations:
city: Tulsa
country: United States
facility: Cancer Treatment Centers of America ® Southwestern Regional Medical Center
state: Oklahoma
Study officials:
affiliation: Cancer Treatment Centers of America at Southwestern Regional Medical Center, Inc.
name: Daniel Nader, DO
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Celikoglu SI, Celikoglu F, Goldberg EP. Intratumoral cancer chemotherapy through a flexible bronchoscope. J Bronchol. 2004;11:260-265.
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