Metastatic Colorectal Cancer
Conditions
Keywords
Metastatic colorectal cancer, Biomarker, Chemotherapy intensification, Syndecan1, LDH, CD138
Brief summary
In first-line metastatic colorectal cancer (mCRC), baseline prognostic factors allowing death risk and strategy stratification are lacking. In this setting, a simple biological scoring system have recently been proposed, including LDH and CD138 binary status seric values, identifying one third of patients with worst prognostic. Intensified-chemotherapy strategies, combining 5-fluorouracile, Oxaliplatin, Irinotecan and Bevacizumab, are beneficial for patients having a bad prognostic, defined by the BRAFV600E mutation, concerning 5-8% of first line mCRC. For the 30% of patients with LDH-CD138 elevated score, the purpose of CLavSyn phase II study is to compare the PFS of one intensified arm (FOLFOXIRI Bevacizumab) to one standard chemotherapy arm, in order to better discriminate treatment strategies, at metastatic diagnosis.
Interventions
DRUGFOLFOXIRI
12 cycles
DRUGFOLFOX
12 cycles
DRUGFOLFIRI
12 cycles
DRUGBevacizumab
12 cycles
DRUGLV5FU2
Maintenance chemotherapy
DRUGCapecitabine
Maintenance chemotherapy
Sponsors
Centre Hospitalier Universitaire de Besancon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 76 Years
Healthy volunteers
No
Inclusion criteria
* Performance status ECOG-WHO 0 or 1 * Histologically proved metastatic colorectal adenocarcinoma, with non-resectable metastases * Adequate hematological, hepatic, and renal functions * Signed written informed consent
Exclusion criteria
* Previous treatment (chemotherapy, targeted therapy, surgery) for metastatic disease * History of autoimmune disease * Acute infectious disease * Known hypersensitivity grade 3-4 or contraindication to any of the study drugs * Patient with any medical or psychiatric condition or disease which would make the patient inappropriate for entry into this study. * Bevacizumab contraindication * Brain metastases * Other malignancy within the last 2 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer. * Pregnancy, breast-feeding or absence of adequate contraception for fertile patients * Patient under guardianship, curator or under the protection of justice.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival | up to 4 years (3 years of inclusion and 12 months of follow up after the last patient included) | Delay from the date of randomization to the disease progression (RECIST) or death from any cause whichever occurs first |
Countries
France
Outcome results
None listed