4D CT Ventilation Image-Guided Personalized Radiation Therapy in Treating Patients with Lung Cancer or Lung Metastasis

This clinical trial studies a four-dimensional (4D) computed tomography (CT) ventilation image-guided personalized radiation therapy in treating patients with lung cancer or cancer that has spread to the lungs. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. 4D CT ventilation image-guided personalized radiation therapy avoids high-functional lung regions which may reduce toxicity and improve tumor control.

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

PRIMARY OBJECTIVE:

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 3-5 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