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
  Purpose

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.


Condition Intervention
Non-small-cell Lung Cancer
Procedure: Functional Imaging of Treatment Effects

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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.

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 15
Study Start Date: February 2002
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Functional Imaging of Treatment Effects
    PET & VQ Scans
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00246116

Sponsors and Collaborators
Jill Deluca
Investigators
Principal Investigator: Ronald McGarry, MD Indiana University - Department of Radiation Oncology
  More Information

No publications provided

Responsible Party: Jill Deluca, Research Coordinator, Indiana University
ClinicalTrials.gov Identifier: NCT00246116     History of Changes
Other Study ID Numbers: 0201-06
Study First Received: October 28, 2005
Last Updated: September 14, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Indiana University:
Lung Cancer
Radiation Oncology
Treated with Stereotatic Body Radiation

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 22, 2014