ctDNA-Informed Management of Early-Stage Rectal Cancer (ULTIMATE)

University of California (UC) Davis

Status and phase

Begins enrollment this month

Phase 2

Conditions

Rectal Adenocarcinoma

Locally Advanced Rectal Adenocarcinoma

Early-stage Rectal Cancer

Rectal Cancer

Treatments

Drug: Signatera Genome ultra-sensitive ctDNA blood test + total neoadjuvant therapy (TNT)

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT07209215

UCDCC322

P30CA093373 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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