Functional Imaging of Treatment Effects: A Companion Protocol to a Study of Extracranial Stereotactic Radioablation in Early Stage Non-Small Cell Lung Cancer (SBF Companion)

January 28, 2022 updated by: Indiana University

Functional Imaging of Treatment Effects: A Companion Protocol to a Phase II Study of Extracranial Stereotactic Radioablation (a.k.a. Stereotactic Body Radiotherapy) in Early Stage Non-Small Cell Lung Cancer.

For this companion protocol, we intend to make an assessment of both tumor response and local tissue effects. Patients undergoing the correlative investigation will be a subset of the patients already enrolled on the phase II study.

Study Overview

Status

Completed

Conditions

Non-small-cell Lung Cancer

Intervention / Treatment

Procedure: Functional Imaging of Treatment Effects

Detailed Description

One of the shortcomings of the trial design recognized in the phase I study had to do with the assessment of local effects, both relating to tumor control and adjacent tissue toxicity. For example, response rates were generally incomplete to the therapy, especially at the lower dose level cohorts, and it was not clear if those patients had residual viable tumor capable of sustaining growth. Repeat biopsies in this population are prohibitively toxic. We generally followed these patients with chest x-rays and CT's until there was evidence of progression. At that point, we would perform a PET scan and repeat systemic staging. Since the majority of patients will retain residual "abnormalities" worrisome for residual disease, ideally, there would be data or testing capable of characterizing these abnormalities earlier in the post-treatment course. In the same token, several patients in the phase I study had post treatment imaging changes around the tumor targets. If these patients had symptomatic decline, it was never clear if the treatment effects around the target were actually involved in the overall decline. Certainly, the patient population selected has other medical problems that will continue to cause poor health. Ideally, though, we would refer to data indicating the degree of damage to surrounding normal lung from the ESR such that a realistic assessment of percentage of overall organ damage from the therapy can be ascertained.

Study Type

Interventional

Enrollment (Actual)

Phase

Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients consented, eligible, and scheduled to be treated on the phase II study of extracranial stereotactic radioablation (a.k.a stereotactic body radiotherapy) for early stage lung cancer already approved at Indiana University

Exclusion Criteria:

Patients with contraindications to functional imaging (e.g. allergy to agent used in studies) and patient unwilling to fulfill requirements of both protocols are ineligible

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To characterize the effect of treatment on tumor metabolic activity as a function of time. Time Frame: 5 years from enrollment	5 years from enrollment

Secondary Outcome Measures

Outcome Measure	Time Frame
To correlate the first two objectives with outcome objectives of the clinical phase II protocol (survival, local control, and toxicity) in order to assess the ultimate utility of these imaging assessments in this patient population. Time Frame: 5 years from completion of enrollment	5 years from completion of enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator: Ronald McGarry, MD, Indiana University - Department of Radiation Oncology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Link to Department of Radiation Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2002

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)