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Implantation of Markers for the Radiotherapy of Lung Cancer Patients


Phase 1
18 Years
N/A
Not Enrolling
Both
Lung Cancer

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Trial Information

Implantation of Markers for the Radiotherapy of Lung Cancer Patients


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.

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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of dropped markers

Outcome Time Frame:

up to 5 years

Safety Issue:

No

Principal Investigator

Elisabeth Weiss, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massey Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

MCC-11284

NCT ID:

NCT00856427

Start Date:

February 2008

Completion Date:

August 2012

Related Keywords:

  • Lung Cancer
  • 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
  • Lung Neoplasms

Name

Location
Virginia Commonwealth University Massey Cancer Center Richmond, Virginia  23298-0037