ctDNA-Informed Management of Early-Stage Rectal Cancer

Phase 2Not Yet RecruitingNCT07209215

University of California, Davis200 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Rectal Adenocarcinoma Rectal Cancer Early-stage Rectal Cancer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Pathologic complete response (pathCR) rate (ctDNA Informed Management Arm)

Percent of participants with local regrowth within 2 years of total neoadjuvant therapy (TNT)

Time frame: Up to 2 years after TNT

Pathologic complete response (pathCR) rate (Post TNT SOC Surgery Arm)

Percent of participants with local regrowth within 2 years of TNT

Time frame: Up to 2 years after TNT

Disease-free survival (DFS) rate (ctDNA Informed Management Arm)

Median interval from first date of TNT to the first occurrence of locoregional failure, distant recurrence, a new invasive colorectal primary cancer.

Time frame: Up to 2 years after TNT

Secondary Outcomes

Frequency of local regrowth (ctDNA Informed Management Arm)

Percentage of participants with local regrowth within 2 years of TNT

Time frame: Up to 2 years after TNT

ctDNA-Informed Management of Early-Stage Rectal Cancer

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts