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Implantation of Markers for the Radiotherapy of Lung Cancer Patients

NCT ID: NCT00856427

Last Updated: 2013-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2012-08-31

Brief Summary

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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

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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.

Conditions

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Lung Cancer

Keywords

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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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

radiation therapy treatment planning/simulation

Intervention Type RADIATION

Undergo implantation of radio-opaque markers

implanted fiducial-based imaging

Intervention Type PROCEDURE

Undergo implantation of radio-opaque markers

Interventions

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radiation therapy treatment planning/simulation

Undergo implantation of radio-opaque markers

Intervention Type RADIATION

implanted fiducial-based imaging

Undergo implantation of radio-opaque markers

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elisabeth Weiss, MD

Role: PRINCIPAL_INVESTIGATOR

Massey Cancer Center

Locations

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Virginia Commonwealth University Massey Cancer Center

Richmond, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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HM11284

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000630623

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2013-00512

Identifier Type: REGISTRY

Identifier Source: secondary_id

MCC-11284

Identifier Type: -

Identifier Source: org_study_id