Early-stage Rectal Cancer, Locally Advanced Rectal Adenocarcinoma, Rectal Adenocarcinoma, Rectal Cancer
Conditions
Brief 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.
Detailed 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.
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.
Sponsors
University of California, Davis
National Cancer Institute (NCI)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 procedures/requirements.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathologic complete response (pathCR) rate (ctDNA Informed Management Arm) | Up to 2 years after TNT | Percent of participants with local regrowth within 2 years of total neoadjuvant therapy (TNT) |
| Pathologic complete response (pathCR) rate (Post TNT SOC Surgery Arm) | Up to 2 years after TNT | Percent of participants with local regrowth within 2 years of TNT |
| Disease-free survival (DFS) rate (ctDNA Informed Management Arm) | Up to 2 years after TNT | Median interval from first date of TNT to the first occurrence of locoregional failure, distant recurrence, a new invasive colorectal primary cancer. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of local regrowth (ctDNA Informed Management Arm) | Up to 2 years after TNT | Percentage of participants with local regrowth within 2 years of TNT |
Countries
United States
Contacts
CONTACTOffice of Clinical Research
PRINCIPAL_INVESTIGATORAnkit Sarin, MD
University of California, Davis
Outcome results
None listed