Clinical trial NCT00856427: Implantation of Markers for the Radiotherapy of Lung Cancer Patients
Official title: Implantation of Markers for the Radiotherapy of Lung Cancer Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Lung Cancer
Keywords: stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IA non-small cell lung cancer
stage IB non-small cell lung cancer
stage IIA non-small cell lung cancer
stage IIB non-small cell lung cancer
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2009-03-05
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This clinical trial studies imaging markers in planning radiation therapy in patients with lung cancer. Implanting markers in the tumor that can be seen using imaging procedures during radiation therapy may allow x-rays to be sent directly to the tumor and cause less damage to normal tissue.

Detailed description: OBJECTIVES:

* To acquire experience in the marker implantation process for mediastinal lymph nodes and primary lung tumors in patients with stage I-IIIB non-small cell lung cancer.
* To characterize the potential side effects involved in the use of markers in these patients.
* To analyze the positional stability of lung markers in these patients over a radiotherapy series.
* To acquire experience in the use of markers for treatment planning and radiotherapy in these patients.

OUTLINE: Patients undergo implantation of ≥ 1 small radio-opaque Visicoil™ marker into or close to the primary lesion and affected lymph nodes by bronchoscopy. Patients then undergo x-rays to document marker location, detect potentially dropped markers, and diagnose operation-related side effects (i.e., pneumothorax). After marker implantation, patients undergo stereotactic or conventionally fractionated radiotherapy for 30-33 daily fractions.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of non-small cell lung cancer

  * Stage I-IIIB disease
* No prior surgical tumor resection
* Respiration-induced tumor motion \> 5 mm
* Recruited by attending physician or research nurse at the Medical College of Virginia Hospitals

PATIENT CHARACTERISTICS:

* Not pregnant
* No insufficient lung function or other parameters prohibiting a bronchoscopy
* Not a prisoner or institutionalized

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* Concurrent chemotherapy allowed

Primary outcomes:
measure: Number of dropped markers
timeFrame: up to 5 years
measure: Marker misplacements
timeFrame: up to 5 years
measure: Implantation-related side effects
timeFrame: up to 5 years
measure: Visibility of markers on CT and x-rays
timeFrame: up to 5 years
measure: Positional reliability of markers
timeFrame: Up to 5 years
measure: Usability for patient treatment
timeFrame: up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University Massey Cancer Center
state: Virginia
Study officials:
affiliation: Massey Cancer Center
name: Elisabeth Weiss, MD
role: PRINCIPAL_INVESTIGATOR
References: