Implantation of Markers for the Radiotherapy of Lung Cancer Patients
This study has been terminated.
(Slow accrual)
Sponsor:
Virginia Commonwealth University
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00856427
First received: March 4, 2009
Last updated: April 12, 2013
Last verified: April 2013
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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
Additional 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: | April 12, 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 June 17, 2013