Clinical trial NCT00246116: Functional Imaging of Treatment Effects: A Companion Protocol to a Study of Extracranial Stereotactic Radioablation in Early Stage Non-Small Cell Lung Cancer
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-small-cell Lung Cancer
Keywords: Lung Cancer
Radiation Oncology
Treated with Stereostatic Body Radiation
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2005-10-30
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: To characterize the effect of treatment on tumor metabolic activity as a function of time.
timeFrame: 5 years from enrollment
Secondary outcomes:
measure: 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.
timeFrame: 5 years from completion of enrollment
Other outcomes:
Locations:
Study officials:
affiliation: Indiana University - Department of Radiation Oncology
name: Ronald McGarry, MD
role: PRINCIPAL_INVESTIGATOR
References: