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

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ClinicalTrials.gov Identifier: NCT04120701
Recruitment Status : Not yet recruiting
First Posted : October 9, 2019
Last Update Posted : October 9, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

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.

Condition or disease Intervention/treatment Phase
Patients With Resected Stage II Colon Cancer Drug: mFOLFOX6 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1980 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CIRCULATING TUMOR DNA BASED DECISION FOR ADJUVANT TREATMENT IN COLON CANCER STAGE II
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : December 2026
Estimated Study Completion Date : December 2027

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



Primary Outcome Measures :
  1. 3-year Disease-Free Survival in ctDNA positive patients [ Time Frame: 3-years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04120701


Contacts
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Contact: Julien TAIEB +33 1 56 09 50 42 julien.taieb@egp.aphp.fr

Locations
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France
Fédération Francophone de Cancérologie Digestive
Dijon, France, 21000
Contact: Flore GEILLON    +33 3 80 39 34 04    flore.geillon@u-bourgogne.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT04120701    
Other Study ID Numbers: PRODIGE 70 - CIRCULATE
First Posted: October 9, 2019    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: September 2019

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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
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases