Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00246116
Status:
COMPLETED
Last Update Posted:
2022-02-11
First Post:
2005-10-28
Brief Title:
Functional Imaging of Treatment Effects A Companion Protocol to a Study of Extracranial Stereotactic Radioablation in Early Stage Non-Small Cell Lung Cancer
Sponsor:
Indiana University
Organization:
Indiana University
Study Overview
Official Title:
Functional Imaging of Treatment Effects A Companion Protocol to a Phase II Study of Extracranial Stereotactic Radioablation aka Stereotactic Body Radiotherapy in Early Stage Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SBF Companion
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 CTs 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None