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Recruiting NCT04120701

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

Phase III Interventional Patients With Resected Stage II Colon Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: mFOLFOX6.
Who it may be relevant to
Registry conditions: Patients With Resected Stage II Colon Cancer. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

  • Drug mFOLFOX6
    Patients receive adjuvant chemotherapy every 2 weeks during 6 months: FOLFOX6m (5-FU, leucovorin and oxaliplatin).

Primary outcome measures

  • 3-year Disease-Free Survival in ctDNA positive patients [Time frame: 3-years]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

France · 1 center
  • Fédération Francophone de Cancérologie Digestive — Dijon

Identifiers

NCT: NCT04120701 · PRODIGE 70 - CIRCULATE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗