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.

Study Overview

• Status: Terminated
• Conditions: Lung Cancer
• Intervention / Treatment: Radiation: radiation therapy treatment planning/simulation; Procedure: implanted fiducial-based imaging

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298-0037
      • Virginia Commonwealth University Massey Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Investigators: Principal Investigator: Elisabeth Weiss, MD, Massey Cancer Center

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: March 4, 2009
• First Submitted That Met QC Criteria: March 4, 2009
• First Posted (Estimate): March 5, 2009

Study Record Updates

• Last Update Posted (Estimate): December 20, 2013
• Last Update Submitted That Met QC Criteria: December 18, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• 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
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: MCC-11284; HM11284 (Other Identifier: VCU IRB); CDR0000630623 (Registry Identifier: PDQ (Physician Data Query)); NCI-2013-00512 (Registry Identifier: CTRP (Clinical Trials Reporting System))