Clinical trial NCT01018147: 4D Image-guided Adaptive Radiotherapy for Lung Cancer: Patient Image Acquisition
Official title: 4D Image-guided Adaptive Radiotherapy for Lung Cancer: Patient Image Acquisition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
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
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-11-23
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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.

Detailed description: OBJECTIVES:

* Quantify the magnitude and distribution of inter- and intrafraction anatomic variations, including the temporal stability of the tumor/respiration signal correlation.
* Improve the acquisition and reconstruction of 4D CT scan images by advancing the 4D CT scan data collection process and evaluating 4D CT scan image reconstruction using different respiratory inputs.
* Quantify the uncertainty of deformable image-registration algorithms.
* Develop and investigate the efficacy of inter- and intrafraction probabilistic planning-based 4D image-guided adaptive radiotherapy (IGART) strategies for clinical application.
* Determine the expected geometric, dosimetric, and radiobiological improvements from the 4D IGART system.

OUTLINE: Patients undergo insertion of ≥ 1 small radio-opaque marker into (or in the vicinity of) the primary lesion or suspect lymph nodes via bronchoscopy. X-rays are performed to document the position of the markers.

Patients undergo 4D CT scan before each radiotherapy session and once a week after a radiotherapy session. Patients also undergo x-ray imaging before and during radiotherapy, optical and internal marker motion recording before and after radiotherapy, and audiovisual feedback during radiotherapy.

Patients undergo image-guided adapted radiotherapy based on these data.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: At least 1 mm reduction in overall systematic error corresponding with ≥ 2 mm CTV-PTV margin reduction
timeFrame: Up to 7 years
measure: At least 5 Gy reduction in mean lung dose
timeFrame: up to 7 years
measure: At least 5% reduction in absolute pneumonitis risk (≥ grade 2)
timeFrame: up to 7 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Massey Cancer Center
name: Jeffrey F. Williamson, PhD
role: PRINCIPAL_INVESTIGATOR
References: