ULtra sensiTive ctDNA-Informed Management eArly-stage recTal cancEr (ULTIMATE)
University of California, Davis
Summary
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.
Description
Two cohorts of participants will be enrolled: Cohort A (participants appropriate for receiving TNT) and Cohort B (TNT already performed at UC Davis Health or externally). At Time A after TNT is completed and based on ctDNA assay results, the clinical decision will be made to put participants into one of two arms: the ctDNA informed management arm (Watchful Waiting \[WW\] surveillance) or the post TNT SOC surgery arm; participants will be monitored for ctDNA positivity for up to 5 years.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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. * Ability to understand and willingness to sign the informed consent form (ICF). * Ability and stated willingness to adhere to the study visit schedule and protocol…
Interventions
- DrugSignatera Genome ultra-sensitive ctDNA blood test + total neoadjuvant therapy (TNT)
Use of Signatera Genome ultra-sensitive ctDNA blood test post-total neoadjuvant therapy (TNT) for ctDNA-informed treatment management of early-stage rectal cancer.
Location
- University of California Davis Comprehensive Cancer CenterSacramento, California