stage II colon cancer, after tumour resection
Conditions
Sponsors
Centre Hospitalier Universitaire (CHU) de Dijon
Eligibility
Sex/Gender
All
Inclusion 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 registration. - 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 =65 years) yes F.1.3.1 Number of subjects for this age range 180
Exclusion criteria
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 - Known DPD deficiency (for patients afterward randomized in chemotherapy arm, DPD deficiency will be mandatory tested prior to 5FU administration) - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to improve Disease Free Survival (DFS) of centralized ctDNA positive patients by the administration of FOLFOX6m adjuvant treatment. The primary endpoint of the study will be to improve 3-year DFS from 25% to 42.5% by the use of adjuvant chemotherapy;Secondary Objective: - To improve Time to recurrence (TTR) in ctDNA positive patients with adjuvant therapy versus without therapy - To improve Overall survival (OS) in ctDNA positive patients with adjuvant therapy versus without therapy - To compare DFS and OS in ctDNA positive versus ctDNA negative patients, without adjuvant treatment - To estimate Toxicities using NCI-CTC v4 classification in ctDNA positive patients with or without adjuvant therapy (to assess treatment tolerability in this population) - To improve the success rate of prognostication of stage II colo-rectal cancer by testing the added value of ctDNA on classical prognostic factors for colo-rectal cancer,To identify biological factors predictive of adjuvant treatment efficacy in ctDNA+ stage II colo-rectal cancer;Primary end point(s): To improve 3-year DFS in ctDNA positive patients from 25 % to 42.5 % by the use of adjuvant oxaliplatin (HR:0.61). Historically the 5-year OS was the traditional endpoint for clinical trials of adjuvant colon cancer treatment. The ACCENT meta-analysis demonstrated that 3-year DFS was an excellent surrogate of 5-year OS [1]. Since this publication, 3-year DFS is the endpoint for adjuvant trials in colon cancer.;Timepoint(s) of evaluation of this end point: 3 years after last patient randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Safety: Toxicities will be graded according to the NCI-CTCAE v 4.0 criteria before each cycle. - OS: will be defined as the time between randomization date and death (any cause). Patients alive will be censored at date of last news. - TTR: will be defined as time from randomization to first event (i.e, first recurrence local or metastatic) or death linked to disease recurrence. Patients alive without event will be censored at the date of the last follow-up. Patients with second colorectal cancer or death form any cause will be censored at the date of the event;Timepoint(s) of evaluation of this end point: 3 years after last patient randomisation | — |
Countries
France
Contacts
Public ContactFlore Geillon
Fédération Francophone de Cancérologie Digestive (FFCD)
Outcome results
None listed