This is a phase 2 pragmatic study to examine the utility of ctDNA-informed treatment management for participants with early-stage rectal cancer using the Signatera Genome assay. The primary aims are to 1) assess pathologic complete response (path CR) in the ctDNA informed management arm; 2) assess pathologic complete response (path CR) in the post total neoadjuvant therapy (TNT) standard of care (SOC) surgery arm; and 3) assess disease free survival (DFS) in the ctDNA informed management arm.
Tumor tissue histologically confirming rectal adenocarcinoma that is available for Natera ctDNA assay.
Cohort A only: Patients appropriate for receiving TNT including chemotherapy and chemoradiation.
Cohort B only: TNT must have included at least 4 cycles of CAPEOX or 6 cycles of FOLFOX and at least 45 Gy in 25 fractions to the pelvis during chemoradiation.
Patients ≥18 years of age at time of consent.
Prior treatment for rectal cancer, except for cohort B.
Evidence of distant metastatic disease on staging imaging (CT chest with abdominopelvic imaging by CT or MRI) within 8 weeks of enrollment.
Patients on hemodialysis.
Any condition that in the opinion of the investigator would interfere with the participant's safety or compliance while on trial
Parallel
Signatera Genome ultra-sensitive ctDNA blood test + total neoadjuvant therapy (TNT)
DrugUse of Signatera Genome ultra-sensitive ctDNA blood test post-total neoadjuvant therapy (TNT) for ctDNA-informed treatment management of early-stage rectal cancer.
Pathologic complete response (pathCR) rate (ctDNA Informed Management Arm)
Percent of participants with local regrowth within 2 years of total neoadjuvant therapy (TNT)
Pathologic complete response (pathCR) rate (Post TNT SOC Surgery Arm)
Percent of participants with local regrowth within 2 years of TNT
Disease-free survival (DFS) rate (ctDNA Informed Management Arm)
Median interval from first date of TNT to the first occurrence of locoregional failure, distant recurrence, a new invasive colorectal primary cancer.
Frequency of local regrowth (ctDNA Informed Management Arm)
Percentage of participants with local regrowth within 2 years of TNT
Click on the lead sponsor to view all of their trials.
University of California, Davis
Lead sponsor
National Cancer Institute (NCI)
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
