Chemotherapy Intensification in Patients With High Lactate Dehydrogenase Values and Soluble Syndecan-1 Levels

API/2016/73

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.

2017-08-04

2024-12-01

2025-12-01

Active (not recruiting)

Early phase I

177

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 177, 'type': 'ESTIMATED'}}

2023-12-22