N/A
N=34
Novel Lung Functional Imaging for Personalized Radiotherapy
Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02308709 ↗Enrolled (actual)
34
Serious AEs
6.1%
Results posted
Nov 2022
Primary outcome: Primary: Grade ≥3 AEs Defined as Definitely, Probably, or Possibly Related to 4D CT Ventilation Image-guided Personalized Radiotherapy — 5 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ventilation image-guided radiotherapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, Davis
- Primary completion
- Nov 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Grade ≥3 AEs Defined as Definitely, Probably, or Possibly Related to 4D CT Ventilation Image-guided Personalized Radiotherapy |
5 | — |
| SECONDARY Radiation Pneumonitis Graded by CTCAE v4.0 |
5 | — |
| SECONDARY Post-treatment Change in Forced Expiratory Volume in 1 Second (FEV1) |
6; -1 | — |
| SECONDARY Post-treatment Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) |
-10; -0.5 | — |
Summary
The primary objective of this study is to assess the safety and feasibility of personalized radiotherapy with four-dimensional (4D) computed tomography (CT)-based pulmonary ventilation imaging, which selectively avoids irradiating highly-functional lung regions.
Eligibility Criteria
Inclusion Criteria
- Primary lung cancer or metastatic disease to the lungs to be treated with either conventionally-fractionated radiotherapy (CFRT) or hypo-fractionated stereotactic ablative radiotherapy (SABR).
- Age restriction and/or gender/ethnic restrictions: Patients must be ≥18 years of age. There are no gender or ethnic restrictions.
- Concurrent chemotherapy is allowed, but not required.
- Life expectancy with treatment should be ≥6 months in the estimation of the treating physicians.
- Zubrod performance status ≤2
- Adequate marrow and hepatic function defined as Hgb ≥8; platelets ≥100k; ANC≥1500; LFTs ≤2x upper limit of normal and creatinine ≤1.3 or creatinine clearance of ≥50
- Patient must be able to provide study specific informed consent prior to study entry.
Exclusion Criteria
- Prior radiotherapy for thoracic cancer or other malignancy leading to any overlap of planned radiotherapy fields.
- For patients undergoing definitive CFRT, patients with distant metastatic disease are not eligible.
- For patients undergoing SABR, both early stage primary lung cancer patients and those with limited metastatic disease to the lungs are eligible; however, patients with oligometastatic disease should have a controlled primary and no more than one other involved organ system.
- Children (<18 years of age), pregnant women, University of California employees or students, or prisoners will be excluded from this study.
Data sourced from ClinicalTrials.gov (NCT02308709). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.