CIRCULATING TUMOR DNA BASED DECISION FOR ADJUVANT TREATMENT IN COLON CANCER STAGE II (CIRCULATE)

The objective of CIRCULATE trial is to improve care of patients after colon tumor surgery, based on an innovative marker: circulating tumor DNA.

Study Overview

• Status: Recruiting
• Conditions: Patients With Resected Stage II Colon Cancer
• Intervention / Treatment: Drug: mFOLFOX6

• Study Type: Interventional
• Enrollment (Anticipated): 1980
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Julien TAIEB; Phone Number: +33 1 56 09 50 42; Email: julien.taieb@egp.aphp.fr

Study Locations

• France
  • Dijon, France, 21000
    • Recruiting
    • Federation Francophone de Cancerologie Digestive
    • Contact: Flore GEILLON; Phone Number: +33 3 80 39 34 04; Email: flore.geillon@u-bourgogne.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Signed written informed consent obtained prior to any study specific procedures
• Age ≥ 18 years and ≤ 75 years
• Histologically confirmed stage II colon and high rectum adenocarcinoma excluding low and medium rectal cancers (tumor location ≥ 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. Pathology report must be faxed to CRGA just after patient's randomization.
• At least 12 lymph nodes analyzed
• Patient with MSI + tumors can be included
• All patients must have been discussed in multidisciplinary meetings with a decision of not performing adjuvant chemotherapy
• No metastatic disease on CT-Scan and/or liver MRI done within 3 months before randomization.
• Randomization planned up to 7 weeks after curative R0 resection
• WHO performance Status < 2
• No prior chemotherapy for colo-rectal cancer
• No prior abdominal or pelvic irradiation for colo-rectal cancer
• Life expectancy of ≥ 5 years
• Adequate haematological function: with neutrophils ≥ 1,500 /mm3, platelet count ≥ 100,000/mm3, hemoglobin ≥ 9 g/dL (5,6 mmol/l)
• Total bilirubin ≤ 1.5 x ULN (upper limit of normal)
• ASAT and ALAT ≤ 2.5 x ULN
• Alkaline phosphatase ≤ 2.5 x ULN
• Serum creatinine ≤ 120 µmol/L or creatinine clearance ≥50 ml/min according MDRD (Modification of Diet in Renal Disease)
• Carcinoembryogenic antigen (CEA) ≤ 1.5 x ULN after surgery (during screening period)
• Negative pregnancy test for registration(for women of childbearing age)
• Patient affiliated to a social security system

Exclusion Criteria:

• T4b tumors
• Peripheral neuropathy > grade 1
• Comorbidity influencing the 5 year patients' survival including clinically relevant cardiovascular disease,
• Ischemic myocardial infarction in the last year and/or unstable ischemic cardiopathy,
• Participation to another interventional study for postoperative therapy
• Partial or complete DPD deficiency
• Legal incapacity or physical, psychological social or geographical status interfering with the patient's ability to sign the informed consent or to finish the study
• 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,
• Lack of effective contraception in patients (men and/or women) of childbearing age, pregnant or breastfeeding women. Women of childbearing potential should agree to use a method of contraception during treatment of the trial and at least 4 months after discontinuation of oxaliplatin therapy and at least 30 days after discontinuation of 5-fluorouracil. Men must agree to use a method of contraception during treatment and at least 6 months after stopping oxaliplatin therapy and at least 3 months after stopping 5-fluorouracil.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Chemotherapy	Drug: mFOLFOX6; Patients receive adjuvant chemotherapy every 2 weeks during 6 months: FOLFOX6m (5-FU, leucovorin and oxaliplatin).
NO_INTERVENTION: Follow-up within the study
NO_INTERVENTION: Follow-up outside the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
3-year Disease-Free Survival in ctDNA positive patients	3-years

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 17, 2020
• Primary Completion (ANTICIPATED): January 1, 2027
• Study Completion (ANTICIPATED): January 1, 2028

Study Registration Dates

• First Submitted: October 8, 2019
• First Submitted That Met QC Criteria: October 8, 2019
• First Posted (ACTUAL): October 9, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 22, 2021
• Last Update Submitted That Met QC Criteria: October 21, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: PRODIGE 70 - CIRCULATE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No