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Chemotherapy Tailored by ctDNA Status for Colon Cancer (CIRCULATE-US Trial)

Phase 2 & 3
Recruiting
Research Sponsored by NRG Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance status of 0 or 1
Histologically/pathologically confirmed colon adenocarcinoma (T1-3, N1/N1c) with R0 resection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from randomization to death, a maximum of 5 years.
Awards & highlights

CIRCULATE-US Trial Summary

This trial will evaluate what kind of chemotherapy to recommend to patients based on the presence or absences of circulating tumor DNA (ctDNA) after surgery for colon cancer.

Who is the study for?
This trial is for adults with colon adenocarcinoma who've had surgery, no metastatic disease, and a good performance status. They must be able to take chemo drugs like 5FU and oxaliplatin, have stable HIV if present, not be pregnant or breastfeeding, and agree to ctDNA testing using the Signatera test.Check my eligibility
What is being tested?
The study tests different chemotherapy durations (3-6 months) using mFOLFOX6 or CAPOX based on circulating tumor DNA presence after colon cancer surgery. It aims to tailor post-surgery chemo treatment more effectively.See study design
What are the potential side effects?
Chemotherapy side effects can include nausea, vomiting, diarrhea, fatigue, risk of infection due to low blood cell counts, neuropathy (nerve problems), and liver function changes.

CIRCULATE-US Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or can carry out light work.
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My colon cancer was confirmed by a lab test and has been fully removed by surgery.
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My tumor is located more than 12 cm from the anal opening or above the peritoneal reflection.
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My tumor was completely removed in one piece.
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My tumor is not affected by certain genetic instabilities.
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I can receive treatments like 5FU, LV, oxaliplatin, and irinotecan.
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I can provide tissue samples from my surgery for further testing.
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I am fully active or can carry out light work.
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My blood, liver, and kidney tests are normal.

CIRCULATE-US Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from randomization to death, a maximum of 5 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and time from randomization to death, a maximum of 5 years. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Disease-Free Survival (DFS)
ctDNA positive status (TTPos)
Secondary outcome measures
Baseline post-surgery ctDNA positivity rate
Compliance with adjuvant chemotherapy
Overall Survival (OS)
+1 more

CIRCULATE-US Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Cohort B - Arm 4 (ctDNA+ve)Experimental Treatment2 Interventions
Oxaliplatin 85 mg/m2 IV + Leucovorin 400mg/m2 IV + Irinotecan 150 mg/m2 IV continuous infusion (30-90 minutes) + 5-Fluorouracil (5-FU) 2400mg/m2 IV continuous infusion over 46-48 hours (total dose) Day1 every 2 weeks for 12 cycles
Group II: Cohort A - Arm 2 (ctDNA-ve)Experimental Treatment1 Intervention
Serial ctDNA monitoring no treatment
Group III: Cohort A - Arm 1 (ctDNA-ve)Active Control3 Interventions
Oxaliplatin 85 mg/m2 IV + Leucovorin 400mg/m2 IV + 5-Fluorouracil (5-FU) 400mg/m2 bolus + 5-Fluorouracil (5-FU) 2400mg/m2 IV continuous infusion over 46-48 hours (total dose) Day1 every 2 weeks for 6-12 cycles OR Oxaliplatin 130 mg/m2 IV Day 1 every 3 weeks + Capecitabine 1000 mg/m2 BID by mouth days 1-14 every 3 weeks for 4 cycles
Group IV: Cohort B - Arm 3 (ctDNA+ve)Active Control3 Interventions
Oxaliplatin 85 mg/m2 IV + Leucovorin 400mg/m2 IV + 5-Fluorouracil (5-FU) 400mg/m2 bolus + 5-Fluorouracil (5-FU) 2400mg/m2 IV continuous infusion over 46-48 hours (total dose) Day1 every 2 weeks for 12 cycles OR Oxaliplatin 130 mg/m2 IV Day 1 every 3 weeks + Capecitabine 1000 mg/m2 BID by mouth days 1-14 every 3 weeks for 8 cycles
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
mFOLFIRINOX
2013
Completed Phase 2
~40

Find a Location

Who is running the clinical trial?

NRG OncologyLead Sponsor
231 Previous Clinical Trials
98,940 Total Patients Enrolled
Natera, Inc.Industry Sponsor
47 Previous Clinical Trials
40,455 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,664 Previous Clinical Trials
40,924,093 Total Patients Enrolled

Media Library

Signatera test Clinical Trial Eligibility Overview. Trial Name: NCT05174169 — Phase 2 & 3
Colon Cancer Research Study Groups: Cohort A - Arm 1 (ctDNA-ve), Cohort A - Arm 2 (ctDNA-ve), Cohort B - Arm 3 (ctDNA+ve), Cohort B - Arm 4 (ctDNA+ve)
Colon Cancer Clinical Trial 2023: Signatera test Highlights & Side Effects. Trial Name: NCT05174169 — Phase 2 & 3
Signatera test 2023 Treatment Timeline for Medical Study. Trial Name: NCT05174169 — Phase 2 & 3
Colon Cancer Patient Testimony for trial: Trial Name: NCT05174169 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What benefits does this research stand to provide?

"The primary outcome being monitored in this clinical trial is the Time to disease-free survival event, which will be followed for up to 5 years. Secondary outcomes include the number of cycles of chemotherapy received, time to disease recurrence, and the percentage of patients with ctDNA positive results post-surgery at study entry."

Answered by AI

Who else is applying?

What state do they live in?
Indiana
Texas
Colorado
What site did they apply to?
Kaiser Permanente-Oakland
Duke Raleigh Hospital
Commonwealth Cancer Center-Corbin
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
3+
0

Why did patients apply to this trial?

I’m interested if I can help with this study. I'm looking for an edge to prevent the cancer from spreading.
PatientReceived no prior treatments
I am interested in helping further research to help people live a better life.
PatientReceived 1 prior treatment
I was successfully treated at UTMB last year but am willing to help if it is beneficial for others.
PatientReceived 1 prior treatment
I do not have any types of cancer that I’m aware of but if you need any non-cancer patients, I would be happy to help.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

Is this a paid study? How many appointments are there? How long does the screening take? Do I have to change anything about my current treatment? Will you work with my oncologist once results are available?
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. University of Texas Medical Branch: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease
2022. "Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05174169.
All > Colorectal Cancer Glendale > Colon Cancer
~1275 spots leftby Mar 2029
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