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

Southwestern Regional Medical Center

Status and phase: Completed; Phase 2

Conditions: Carcinoma, Non-Small-Cell Lung

Treatments: Drug: Cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00379665

CTCT 05-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Cisplatin

Experimental group

Description:

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

Treatment:

Drug: Cisplatin