4D Image-guided Adaptive Radiotherapy for Lung Cancer: Patient Image Acquisition
4 other identifiers
interventional
22
0 countries
N/A
Brief Summary
This clinical trial studies 4-dimensional (4-D) image-guided radiation therapy treatment planning in patients with stage I-IV non-small cell lung cancer. Computed tomography (CT) scans and treatment-planning systems may help in planning radiation therapy for patients with non-small cell lung cancer. This is not a therapy study. Therefore no direct benefit from participating is expected. However, at the discretion of the treating physician, the information gained from the additional imaging will be used to improve treatment accuracy. No patient outcome data are gathered or analyzed by this study. This study is not a:Phase I, II, or III trial, trial with "blinded" treatment arm, gene or a vaccine trial, or a multi-institutional trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable lung-cancer
Started Sep 2006
Longer than P75 for not_applicable lung-cancer
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 20, 2009
CompletedFirst Posted
Study publicly available on registry
November 23, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedFebruary 8, 2016
February 1, 2016
5.6 years
November 20, 2009
February 4, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
At least 1 mm reduction in overall systematic error corresponding with ≥ 2 mm CTV-PTV margin reduction
Up to 7 years
At least 5 Gy reduction in mean lung dose
up to 7 years
At least 5% reduction in absolute pneumonitis risk (≥ grade 2)
up to 7 years
Study Arms (1)
CT Imaging
EXPERIMENTALPatients undergo 4-D, 4-dimensional computed tomography, CT imaging prior to radiotherapy sessions and once a week at the end of treatment.
Interventions
Eligibility Criteria
You may qualify if:
- Histologic or cytologic confirmation of non-small cell lung cancer stages I-IV
- Partial pressure oxygen (pO2) \> 92%-obtained at the time of or within 3 months prior to initial consultation with the radiation oncologist
- Tumor(s) must be visualized on a CT
- Positron emission tomography (PET) is performed during staging or treatment planning process
- All patients must be informed on the investigational nature of this study and must give informed consent in accordance with institutional guidelines
You may not qualify if:
- Pregnant women may not participate; women of reproductive potential must be informed of the need to practice an effective contraceptive method
- Unstable coronary artery disease
- Uncorrectable coagulopathy
- Severe pulmonary hypertension
- Poor tolerance of conscious sedation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Virginia Commonwealth Universitylead
- National Cancer Institute (NCI)collaborator
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffrey F. Williamson, PhD
Massey Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2009
First Posted
November 23, 2009
Study Start
September 1, 2006
Primary Completion
April 1, 2012
Study Completion
October 1, 2015
Last Updated
February 8, 2016
Record last verified: 2016-02