4D CT Ventilation Image-Guided Personalized Radiation Therapy in Treating Patients with Lung Cancer or Lung Metastasis
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)
- There are no 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
- Hemoglobin (Hgb) >= 8
- Platelets >= 100k
- Absolute neutrophil count (ANC) >= 1500
- Liver function test (LFTs) =< 2 x upper limit of normal
- Creatinine =< 2.0
- Creatinine clearance of >= 40
- 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
- We will carefully consider the inclusion of patients with severe artifacts in 4D CT images, which deteriorate the accuracy of ventilation computation
California
Sacramento
PRIMARY OBJECTIVES:
I. Assess the safety and feasibility of 4D CT ventilation image-guided personalized radiotherapy that selectively avoids irradiating highly-functional lung regions for lung cancer.
SECONDARY OBJECTIVES:
I. Assess long-term toxicity from 4D CT ventilation image-guided personalized radiotherapy as scored by the National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
II. Estimate the clinical significance of 4D CT ventilation image-guided personalized radiotherapy by evaluating: clinical and subclinical endpoints for pulmonary toxicity (including symptomatic radiation pneumonitis and post-treatment changes in pulmonary function tests (PFTs), 6- minute (min) walk test, and body-mass index, airflow obstruction, dyspnea, and exercise capacity index (BODE index); correlation between those endpoints and functional dose-volume parameters.
III. Assess local tumor control after 4D CT ventilation image-guided personalized radiotherapy.
IV. Quantify the dosimetric significance of 4D CT ventilation image-guided adaptive radiotherapy.
V. Investigate whether in vivo electronic portal imaging device (EPID) dosimetry can detect clinically significant anatomic changes for patients treated with conventionally-fractionated radiation therapy (CFRT).
OUTLINE:
Patients undergo 4D CT ventilation image-guided personalized radiation therapy with 30 fractions of CFRT or 3 fractions of hypofractionated stereotactic ablative radiation therapy (SABR) over 3-8 weeks.
After completion of study treatment, patients are followed up every 3 months for up to 2 years.
Trial Phase Phase I
Trial Type Treatment
Lead Organization
University of California Davis Comprehensive Cancer Center
Principal Investigator
Tokihiro Yamamoto
- Primary ID CCRO030
- Secondary IDs NCI-2015-01628, NCI-2015-01530
- Clinicaltrials.gov ID NCT02308709