Implantation of Markers for the Radiotherapy of Lung Cancer Patients

This study has been terminated.
(Slow accrual)
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00856427
First received: March 4, 2009
Last updated: December 18, 2013
Last verified: December 2013

March 4, 2009
December 18, 2013
February 2008
January 2012   (final data collection date for primary outcome measure)
  • Number of dropped markers [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
  • Marker misplacements [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
  • Implantation-related side effects [ Time Frame: up to 5 years ] [ Designated as safety issue: Yes ]
  • Visibility of markers on CT and x-rays [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
  • Positional reliability of markers [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Usability for patient treatment [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
  • Experience in the use of markers for treatment planning and radiotherapy [ Designated as safety issue: No ]
  • Experience in the marker implantation process for mediastinal lymph nodes and primary lung tumors [ Designated as safety issue: No ]
  • Potential side effects involved in the use of markers [ Designated as safety issue: Yes ]
  • Positional stability of lung markers over a radiotherapy series [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00856427 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Implantation of Markers for the Radiotherapy of Lung Cancer Patients
Implantation of Markers for the Radiotherapy of Lung Cancer Patients

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.

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.

Interventional
Phase 1
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lung Cancer
  • Radiation: radiation therapy treatment planning/simulation
    Undergo implantation of radio-opaque markers
  • Procedure: implanted fiducial-based imaging
    Undergo implantation of radio-opaque markers
Experimental: Diagnostic
Patients undergo implantation of radio-opaque markers into the primary lesion and affected lymph nodes by bronchoscopy. Patients then undergo routine 4D CT, 4D CBCT, fluoroscopy, and x-ray imaging during standard stereotactic radiation therapy (early stage tumors) or conventionally fractionated radiation therapy (advanced stage tumors).
Interventions:
  • Radiation: radiation therapy treatment planning/simulation
  • Procedure: implanted fiducial-based imaging
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
6
August 2012
January 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00856427
MCC-11284, HM11284, CDR0000630623, NCI-2013-00512
Yes
Virginia Commonwealth University
Virginia Commonwealth University
Not Provided
Principal Investigator: Elisabeth Weiss, MD Massey Cancer Center
Virginia Commonwealth University
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP