N/A
N=101
Feasibility Study Incorporating Lung Function Imaging Into Radiation Therapy for Lung Cancer Patients
Lung Neoplasms · Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02528942 ↗Enrolled (actual)
101
Serious AEs
14.9%
Results posted
Jul 2021
Primary outcome: Primary: Radiation Safety (Rate of Grade 2 or Higher (Grade 2+) Radiation Pneumonitis as Defined by the Common Toxicity Criteria for Adverse Effects (CTCAE) Scoring System — 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Radiation therapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- Jan 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Radiation Safety (Rate of Grade 2 or Higher (Grade 2+) Radiation Pneumonitis as Defined by the Common Toxicity Criteria for Adverse Effects (CTCAE) Scoring System |
10 | — |
| SECONDARY Percentage of Patients Eligible for 4DCT-ventilation Functional Avoidance |
9 | — |
Summary
The proposed study is in the field of thoracic radiation oncology where radiation therapy is used to treat lung cancer. The primary objective of the early phase clinical trial will be to evaluate the safety of performing functional avoidance radiation therapy for lung cancer patients using 4D computed tomography (4DCT) ventilation imaging.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of pathologically confirmed lung cancer by tumor biopsy and/or fine-need aspiration
- Lung Cancer patients that will undergo definitive radiation therapy defined as 45-75 Gy as part of standard of care for their disease
- 18 years of age or older
- Signed informed consent
- Planned curative intent chemotherapy, delivered concurrently or sequentially in combination with radiotherapy
- The patient's 4DCT-ventilation image meets image heterogeneity criteria
Exclusion Criteria
- Patients receiving Stereotactic Body Radiation Therapy
- Patient receiving palliative radiation therapy (defined as less than 45 Gy)
Data sourced from ClinicalTrials.gov (NCT02528942). 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.