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)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jill Deluca, Indiana University
ClinicalTrials.gov Identifier:
NCT00246116
First received: October 28, 2005
Last updated: September 14, 2011
Last verified: September 2011

October 28, 2005
September 14, 2011
February 2002
July 2011   (final data collection date for primary outcome measure)
To characterize the effect of treatment on tumor metabolic activity as a function of time. [ Time Frame: 5 years from enrollment ] [ Designated as safety issue: No ]
  • To characterize the effect of treatment on tumor metabolic activity as a function of time.
  • To characterize the effect of treatment on local and regional alveolar ventilation and vascular perfusion as a function of time.
Complete list of historical versions of study NCT00246116 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
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.
Not Provided
Not Provided
 
Functional Imaging of Treatment Effects: A Companion Protocol to a Study of Extracranial Stereotactic Radioablation in Early Stage Non-Small Cell Lung Cancer
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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Non-small-cell Lung Cancer
Procedure: Functional Imaging of Treatment Effects
PET & VQ Scans
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
July 2011
July 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00246116
0201-06
Yes
Jill Deluca, Indiana University
Jill Deluca
National Cancer Institute (NCI)
Principal Investigator: Ronald McGarry, MD Indiana University - Department of Radiation Oncology
Indiana University
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP