ctDNA-Informed Management of Early-Stage Rectal Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-03-31

Study Completion Date

2028-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Rectal Adenocarcinoma Rectal Cancer Early-stage Rectal Cancer Locally Advanced Rectal Adenocarcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ctDNA informed management arm (Watch and Wait surveillance)

Group Type EXPERIMENTAL

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

Intervention Type DRUG

Use of Signatera Genome ultra-sensitive ctDNA blood test post-total neoadjuvant therapy (TNT) for ctDNA-informed treatment management of early-stage rectal cancer.

Post TNT SOC surgery arm

Group Type EXPERIMENTAL

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

Intervention Type DRUG

Use of Signatera Genome ultra-sensitive ctDNA blood test post-total neoadjuvant therapy (TNT) for ctDNA-informed treatment management of early-stage rectal cancer.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No