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Not yet recruiting NCT07209215

ctDNA-Informed Management of Early-Stage Rectal Cancer

Phase II Interventional Rectal Adenocarcinoma Rectal Cancer Early-stage Rectal Cancer Locally Advanced Rectal Adenocarcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Signatera Genome ultra-sensitive ctDNA blood test + total neoadjuvant therapy (TNT).
Who it may be relevant to
Registry conditions: Rectal Adenocarcinoma, Rectal Cancer, Early-stage Rectal Cancer, Locally Advanced Rectal Adenocarcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

  • Drug Signatera 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.

Primary outcome measures

  • Pathologic complete response (pathCR) rate (ctDNA Informed Management Arm) [Time frame: Up to 2 years after TNT]
  • Pathologic complete response (pathCR) rate (Post TNT SOC Surgery Arm) [Time frame: Up to 2 years after TNT]
  • Disease-free survival (DFS) rate (ctDNA Informed Management Arm) [Time frame: Up to 2 years after TNT]
Secondary outcome measures (1)
  • Frequency of local regrowth (ctDNA Informed Management Arm) [Time frame: Up to 2 years after TNT]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of California Davis Comprehensive Cancer Center — Sacramento

Identifiers

NCT: NCT07209215 · UCDCC322 · P30CA093373 · NCI-2026-00131

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗