This study is not yet accepting patients

ctDNA-Informed Management of Early-Stage Rectal Cancer

a study on Colorectal Cancer Rectal Cancer

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis
Dates
study started
study ends around
Principal Investigator
by Ankit Sarin, MD (ucdavis)
Headshot of Ankit Sarin
Ankit Sarin

Description

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.

Official Title

ULtra sensiTive ctDNA-Informed Management eArly-stage recTal cancEr (ULTIMATE)

Details

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.

Keywords

Rectal Adenocarcinoma, Rectal Cancer, Early-stage Rectal Cancer, Locally Advanced Rectal Adenocarcinoma, Rectal Neoplasms, Signatera Genome ultra-sensitive ctDNA blood test + total neoadjuvant therapy (TNT)

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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

Location

  • University of California Davis Comprehensive Cancer Center
    Sacramento 5389489 California 5332921 95817 United States

Lead Scientist at University of California Health

  • Ankit Sarin, MD (ucdavis)
    Professor, Med: Surgery, School of Medicine. Authored (or co-authored) 32 research publications

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Davis
ID
NCT07209215
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 200 study participants
Last Updated