ctDNA-Informed Management of Early-Stage Rectal Cancer

Sponsor: University of California, Davis

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT07209215

Patient View

This phase 2 study evaluates ctDNA-informed management for early-stage rectal cancer using the Signatera assay. Participants are divided into two cohorts based on TNT status. Eligibility includes confirmed rectal adenocarcinoma and specific TNT criteria. The intervention involves ctDNA testing post-TNT to guide treatment, with monitoring for up to 5 years.

Patient Parameters

Program 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.

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.

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

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