search
Back to results

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

Primary Purpose

Patients With Resected Stage II Colon Cancer

Status
Recruiting
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
mFOLFOX6
Sponsored by
Centre Hospitalier Universitaire Dijon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patients With Resected Stage II Colon Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fédération Francophone de Cancérologie DigestiveRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

No Intervention

Arm Label

Chemotherapy

Follow-up within the study

Follow-up outside the study

Arm Description

Outcomes

Primary Outcome Measures

3-year Disease-Free Survival in ctDNA positive patients

Secondary Outcome Measures

Full Information

First Posted
October 8, 2019
Last Updated
October 21, 2021
Sponsor
Centre Hospitalier Universitaire Dijon
search

1. Study Identification

Unique Protocol Identification Number
NCT04120701
Brief Title
CIRCULATING TUMOR DNA BASED DECISION FOR ADJUVANT TREATMENT IN COLON CANCER STAGE II
Acronym
CIRCULATE
Official Title
CIRCULATING TUMOR DNA BASED DECISION FOR ADJUVANT TREATMENT IN COLON CANCER STAGE II
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 17, 2020 (Actual)
Primary Completion Date
January 2027 (Anticipated)
Study Completion Date
January 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon

4. Oversight

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

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Resected Stage II Colon Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1980 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chemotherapy
Arm Type
Experimental
Arm Title
Follow-up within the study
Arm Type
No Intervention
Arm Title
Follow-up outside the study
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
mFOLFOX6
Intervention Description
Patients receive adjuvant chemotherapy every 2 weeks during 6 months: FOLFOX6m (5-FU, leucovorin and oxaliplatin).
Primary Outcome Measure Information:
Title
3-year Disease-Free Survival in ctDNA positive patients
Time Frame
3-years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julien TAIEB
Phone
+33 1 56 09 50 42
Email
julien.taieb@egp.aphp.fr
Facility Information:
Facility Name
Fédération Francophone de Cancérologie Digestive
City
Dijon
ZIP/Postal Code
21000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Flore GEILLON
Phone
+33 3 80 39 34 04
Email
flore.geillon@u-bourgogne.fr

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs