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OpenTrials
Completed

NCT Number: NCT00379665

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

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.

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Key information

Conditions

Carcinoma, Non-Small-Cell Lung Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cancer Treatment Centers of America ® Southwestern Regional Medical Center

Tulsa, Oklahoma, 74133, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cisplatin

Drug

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

Primary outcomes

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

    Time frame: within 4 to 6 injections

Secondary outcomes

  1. Respiratory symptoms due to occlusion to be assessed both before and after the procedure.

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Southwestern Regional Medical Center

Other

Registry information

Important dates

Study start
2005
Primary completion
2010
Study completion
2012
First posted
Sep 22, 2006
Registry last updated
Dec 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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