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

Phase 2

Completed

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Drug: Cisplatin

• Registration Number: NCT00379665
• Lead Sponsor: Southwestern Regional Medical Center

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.

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2006-09-20
• Study First Submitted QC: 2006-09-20
• Study First Posted: 2006-09-22
• Primary Completion: 2010-12
• Study Completion: 2012-09
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-10
• Last Update Posted: 2012-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cisplatin	Cisplatin	1 mg/ml at a dosage of approximately 2 mg per cubic cm of tumor. Weekly up to 6 injections.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Respiratory symptoms due to occlusion to be assessed both before and after the procedure.	3 years

Trial Locations

Locations (1)

Cancer Treatment Centers of America ® Southwestern Regional Medical Center; 🇺🇸 Tulsa, Oklahoma, United States