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
About this trial
This is an interventional treatment trial for Patients With Resected Stage II Colon Cancer
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.
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
NCT ID
NCT04120701
First Posted
October 8, 2019
Last Updated
October 21, 2021
Sponsor
Centre Hospitalier Universitaire Dijon
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
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