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

Non-small-cell Lung Cancer Clinical Trial

— SBF Companion  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00246116
• Other study ID #: 0201-06
• Status: Completed
• Phase: N/A
• Start date: February 2002
• Est. completion date: July 2011

Study information

• Verified date: January 2022
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small-cell Lung Cancer

Intervention

Procedure:
• Functional Imaging of Treatment Effects
PET & VQ Scans

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To characterize the effect of treatment on tumor metabolic activity as a function of time.		5 years from enrollment
Secondary	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.		5 years from completion of enrollment

External Links

•   Link to Department of Radiation Oncology