Ignite Creation Date:
2024-05-06 @ 3:33 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04670588
Status:
WITHDRAWN
Last Update Posted:
2022-07-18
First Post:
2020-12-10
Brief Title:
Response Assessment by Circulating Tumor DNA in Patients With Locally Advanced Rectal Cancer
Sponsor:
Medical College of Wisconsin
Organization:
Medical College of Wisconsin
Study Overview
Official Title:
A Prospective Observational Study to Determine the Feasibility of Tumor Response Assessment by Circulating Tumor DNA in Patients With Locally Advanced Rectal Cancer Undergoing Total Neoadjuvant Therapy
Status:
WITHDRAWN
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single-arm observational study to determine the feasibility of assessing tumor response utilizing Circulating tumor DNA ctDNA in patients of with locally advanced rectal cancer LARC undergoing standard-of-care total neoadjuvant therapy TNT consisting of systemic chemotherapy modified FOLFOX or modified FOLFIRINOX followed by concurrent chemoradiation 504 Gy over approximately six weeks with concurrent radiosensitizing dose of capecitabine5-fluorouracil
Detailed Description:
In this observational study patients with LARC who are selected for the standard-of-care TNT will be enrolled After obtaining informed consent a venous blood sample and the archival tissue block from the initial diagnostic rectal tumor biopsy will be sent to the Natera laboratory for designing patient-specific ctDNA assay which will be used to measure ctDNA levels in the peripheral venous blood samples at various time points coinciding with the standard studies to assess tumor response The blood sample needed for designing the assay and measuring the baseline ctDNA level will be obtained within four weeks before neoadjuvant chemotherapy begins Subsequently for patients undergoing 16 weeks of neoadjuvant chemotherapy blood samples will be obtained for ctDNA level measurement at three time points after eight weeks4 cycles of neoadjuvant chemotherapy within - 5 days of the magnetic resonance imaging MRI study after 16 weeks8 cycles of neoadjuvant chemotherapy within - 5 days of the MRI study and one to 14 days before surgery For patients who receive eight weeks of neoadjuvant chemotherapy two blood samples will be obtained for subsequent ctDNA measurements after eight weeks4 cycles of neoadjuvant chemotherapy within - 5 days of the MRI study and one to 14 days before surgery All patients may also choose to undergo additional serial ctDNA level measurements for surveillance after the surgery every three to four months for two years optional
Tumor response rate assessed by ctDNA defined as reduction of ctDNA level at least by 90 compared to the baseline level will be compared with the response rate assessed by the standard method proctoscopic examination pelvic MRI etc to explore if a significant correlation exists between these two response assessment methods If preliminary data support the hypothesis that peripheral blood ctDNA can be utilized for tumor response assessment in this scenario a larger study will be conducted to validate this method Once validated ctDNA measurement can potentially replace expensive uncomfortable and time-consuming methods of tumor response assessment like MRI
Tumor response rate assessed by ctDNA defined as reduction of ctDNA level at least by 90 compared to the baseline level will be compared with the response rate assessed by the standard method proctoscopic examination pelvic MRI etc to explore if a significant correlation exists between these two response assessment methods If preliminary data support the hypothesis that peripheral blood ctDNA can be utilized for tumor response assessment in this scenario a larger study will be conducted to validate this method Once validated ctDNA measurement can potentially replace expensive uncomfortable and time-consuming methods of tumor response assessment like MRI
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None