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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
Must not have
Colon cancer histology other than adenocarcinoma
Pathologic, clinical, or radiologic overt evidence of metastatic disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from randomization to death, a maximum of 5 years.
Awards & highlights

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My colon cancer is not adenocarcinoma.
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My cancer has spread to other parts of my body.
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My cancer has caused a hole in my intestine.
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I have had colon cancer before.
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I have had a bone marrow or organ transplant.
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I have had chemotherapy, targeted therapy, immunotherapy, or radiation for colorectal cancer.
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I have not had any other cancer besides this one in the last 5 years.
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I have cancer in both my rectum and colon at the same time.
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My heart condition limits my physical activity.
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I have moderate to severe numbness, tingling, or muscle weakness.
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I have seizures that medication does not control.
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I am currently on medication for a long-term infection.
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I have a confirmed DPD deficiency.
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I have Gilbert's Syndrome or a specific genetic condition (UGT1A1*28).

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

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for colon cancer include chemotherapy regimens such as fluoropyrimidines (e.g., 5-fluorouracil), oxaliplatin, and irinotecan. Fluoropyrimidines work by inhibiting thymidylate synthase, an enzyme crucial for DNA synthesis, thereby preventing cancer cell replication. Oxaliplatin forms platinum-DNA adducts, causing DNA crosslinking and apoptosis. Irinotecan inhibits topoisomerase I, an enzyme involved in DNA replication, leading to DNA damage and cell death. The use of ctDNA biomarkers in guiding chemotherapy regimens is significant as it allows for personalized treatment plans, potentially improving efficacy and reducing unnecessary toxicity. This approach is particularly important for colon cancer patients, as it can help identify those who are more likely to benefit from specific chemotherapeutic agents, thereby optimizing treatment outcomes.
A Canadian single institution real-world experience using the CROSS trial regimen in the treatment of oesophageal and gastroesophageal junction carcinoma.Efficacy of carboplatin chemotherapy in a metastatic, castration-resistant BRCA2 mutation positive prostate cancer patientNeoadjuvant Chemotherapy Considerations in Triple-Negative Breast Cancer.

Find a Location

Who is running the clinical trial?

NRG OncologyLead Sponsor
232 Previous Clinical Trials
98,837 Total Patients Enrolled
Natera, Inc.Industry Sponsor
49 Previous Clinical Trials
40,875 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,957,489 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
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