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


Phase 2
20 Years
80 Years
Not Enrolling
Both
Carcinoma, Non-Small-Cell Lung

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To affect a faster clearing of the obstruction as compared with initial evaluation, based on the percentage of lumen opened.

Outcome Time Frame:

within 4 to 6 injections

Safety Issue:

No

Principal Investigator

Daniel Nader, DO

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Treatment Centers of America at Southwestern Regional Medical Center, Inc.

Authority:

United States: Institutional Review Board

Study ID:

CTCT 05-01

NCT ID:

NCT00379665

Start Date:

October 2005

Completion Date:

September 2012

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Lung
  • Chemotherapy
  • Cisplatin
  • Intratumoral
  • Bronchoscope
  • Brachytherapy
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung

Name

Location
Cancer Treatment Centers of America ® Southwestern Regional Medical Center Tulsa, Oklahoma  74133