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Personalizing Chemotherapy Selection After Surgery for Patients With Stage III Colorectal Cancer Using a Blood Test

Tailoring the Decision for Adjuvant Chemotherapy Using Circulating Tumour DNA, in Patients With Stage III Colorectal Cancer

NCT07340567•UNICANCER

View on ClinicalTrials.gov

Summary

CIRCULATE-III is an international, multicenter, open-label, randomized phase III trial designed to use ctDNA as a selection criterion for intensification or de-escalation of adjuvant chemotherapy. Eligible patients are randomly assigned to the following treatment groups: * Patients who test negative for ctDNA receive either capecitabine for 6 months (experimental group) or oxaliplatin + capecitabine for 3 months (standard group). * Patients who test positive for ctDNA receive either FOLFIRINOX for 6 months (experimental group) or FOLFOX for 6 months (standard group). Patient participation in the trial will not exceed 66 months after randomization, including a maximum treatment duration of 6 months and a follow-up period of 60 months.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patient must have signed a written informed consent prior to any trial specific procedures. When the patient is physically unable to give their written consent, an impartial witness of their choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent
•2. Age ≥18 years and \<80 years (for patients aged \>70 years: G8 geriatric questionnaire score\>14)
•3. Histologically confirmed stage III pMMR/MSS colon and high rectum adenocarcinoma (T, N1 or N2, M0) excluding medium and low rectal cancers (≥12 cm from the anal verge by endoscopy and/or above the peritoneal reflection at surgery are still eligible), without gross or microscopic evidence of residual disease after surgery with curative intent.
•4. No metastatic disease on CT-Scan and/or liver MRI done within 2 months before inclusion
•5. Inclusion planned between 10 days to 6 weeks after surgery
•6. ECOG performance status 0-1 (fit to receive FOLFIRINOX therapy)
•7. No prior chemotherapy for CRC
•8. No prior abdominal or pelvic irradiation for CRC
•9. Adequate hematological function: neutrophils ≥1,500 /mm3, platelet count ≥100,000/mm3, hemoglobin ≥9 g/dL (5,6 mmol/L)
•10. Total bilirubin ≤1.5 x ULN (upper limit of normal)
+8 more criteria

Exclusion Criteria

•1. Peripheral neuropathy grade ≥1
•2. Patients who have received neo-adjuvant treatment.
•3. Comorbidity influencing the 3-year patients' survival including clinically relevant cardiovascular disease, such as Ischemic myocardial infarction in the last year and/or unstable ischemic cardiopathy
•4. Contra-indication to chemotherapy (inadequate bone marrow, hepatic, renal functions, hypersensitivity to one of the treatments or any of the excipients)
•5. Patient must not have received bone marrow transplant
•6. Patient must not have received blood transfusion within 3 months before inclusion
•7. Participation in another therapeutic trial
•8. Partial or complete dihydropyrimidine deshydrogenase (DPD) deficiency.
•9. MSI/dMMR tumors
•10. Medical history of other concomitant or previous malignant disease, except adequately treated in situ carcinoma of the uterine cervix, basal or squamous cell carcinoma of the skin, or cancer in complete remission for ≥ 5 years.
+3 more criteria

Locations (5)

Institut Gustave Roussy

Villejuif, France

Sahlgrenska University Hospital

Gothenburg, Sweden

Skäne University Hospital

Lund, Sweden

Södersjukhuset

Stockholm, Sweden

Onkologikliniken

Uppsala, Sweden

Key Dates

Start Date

May 1, 2026

Primary Completion Date

November 1, 2032

Completion Date

November 1, 2035

Last Updated

January 14, 2026

Enrollment

2,450

ESTIMATED participants

Conditions

Colorectal Cancer

Interventions

Capecitabine

DRUG

Oxaliplatin

DRUG

Folfirinox

DRUG

FOLFOX regimen

DRUG

Contacts

Emilie BRUMENT, MsC

CONTACT

+33(0)171936164 e-brument@unicancer.fr

Léonor BENHAIM, MD

CONTACT

Leonor.BENHAIM@gustaveroussy.fr

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

NCT04704661

Advanced Breast CarcinomaAdvanced Colon Carcinoma+38 more

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RECRUITINGPHASE1

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

NCT06696768

Metastatic Colorectal AdenocarcinomaStage III Colorectal Cancer AJCC v8+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 14, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Personalizing Chemotherapy Selection After Surgery for Patients With Stage III Colorectal Cancer Using a Blood Test

Inclusion Criteria

Exclusion Criteria

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

Evaluation of the Safety and Efficacy of Treatment w/High Dose Melphalan Given Directly Into the Liver Followed by Treatment w/Approved Cancer Treatment or Approved Cancer Treatment Alone in Patients w/ Metastatic Colorectal Cancer w/Liver Dominant Disease