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

Trial Status: Closed to Accrual

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

California

Sacramento
University of California Davis Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Tokihiro Yamamoto
Phone: 916-734-0604

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