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
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Radiation: radiation therapy treatment planning/simulation
Procedure: implanted fiducial-based imaging
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Implantation of Markers for the Radiotherapy of Lung Cancer Patients

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • 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 ]

Enrollment: 6
Study Start Date: February 2008
Study Completion Date: August 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
Radiation: radiation therapy treatment planning/simulation
Undergo implantation of radio-opaque markers
Procedure: implanted fiducial-based imaging
Undergo implantation of radio-opaque markers

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00856427

Locations
United States, Virginia
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, United States, 23298-0037
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: Elisabeth Weiss, MD Massey Cancer Center
  More Information

No publications provided

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00856427     History of Changes
Other Study ID Numbers: MCC-11284, HM11284, CDR0000630623, NCI-2013-00512
Study First Received: March 4, 2009
Last Updated: December 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:
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

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 16, 2014