Lung Cancer
Conditions
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
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.
Interventions
Undergo implantation of radio-opaque markers
PROCEDUREimplanted fiducial-based imaging
Undergo implantation of radio-opaque markers
Sponsors
Virginia Commonwealth University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of dropped markers | up to 5 years |
| Marker misplacements | up to 5 years |
| Implantation-related side effects | up to 5 years |
| Visibility of markers on CT and x-rays | up to 5 years |
| Positional reliability of markers | Up to 5 years |
| Usability for patient treatment | up to 5 years |
Countries
United States
Outcome results
None listed