Novel Lung Functional Imaging for Personalized Radiotherapy

Lung Cancer Clinical Trial

Official title:

Novel Lung Functional Imaging for Personalized Radiotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02308709
• Other study ID #: 472677
• Secondary ID: CCRO030
• Status: Completed
• Phase: N/A
• Start date: September 15, 2014
• Est. completion date: November 19, 2021

Study information

• Verified date: October 2022
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

In this clinical trial, the investigators will assess the safety and feasibility of 4D CT ventilation image-guided personalized radiotherapy. The investigators will deliver personalized radiotherapy treatments that selectively avoid irradiating highly-functional lung regions for lung cancer patients, and follow up patients to assess the safety and feasibility. The primary hypothesis to be tested is: 4D CT ventilation image-guided personalized radiotherapy can be delivered safely for lung cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: November 19, 2021
• Est. primary completion date: November 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer

Intervention

Radiation:
• Ventilation image-guided radiotherapy
Patient's treatment plan will be created and optimized to minimize the dose to highly-functional lung regions

Locations

Country	Name	City	State
United States	University of California Davis Medical Center	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Grade =3 AEs Defined as Definitely, Probably, or Possibly Related to 4D CT Ventilation Image-guided Personalized Radiotherapy	Number of subjects experiencing Grade =3 AEs, i.e., Grade =3 radiation pneumonitis, grade =3 esophagitis, or other grade =3 AEs, defined as definitely, probably, or possibly related to 4D CT ventilation image-guided personalized radiotherapy.	12 months
Secondary	Radiation Pneumonitis Graded by CTCAE v4.0	Number of participants with Grade = 2 radiation pneumonitis adverse event graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.	2 years
Secondary	Post-treatment Change in Forced Expiratory Volume in 1 Second (FEV1)	The median absolute change from baseline in FEV1 (% predicted) at 6 months after treatment.	Baseline and 6 months
Secondary	Post-treatment Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)	The median absolute change from baseline in DLCO (% predicted) at 6 months after treatment.	Baseline and 6 months