Chemotherapy Intensification in Patients With High Lactate Dehydrogenase Values and Soluble Syndecan1 Levels
Reason given: enrollment too slow
Key facts
- Where
- Besançon, Boulogne-sur-Mer, Colmar, Dijon, Lille, Montbéliard, Reims, Strasbourg, and Tours, FranceSee the 10 sites
- Phase
- Phase 2
Where in France
- Centre Hospitalier Universitaire de BesançonBesançon, FranceNo longer taking part
- Centre Hospitalier de Boulogne-Sur-MerBoulogne-sur-Mer, FranceNo longer taking part
- CH de ColmarColmar, FranceNo longer taking part
- Institut de Cancérologie de BourgogneDijon, FranceNo longer taking part
- CHRU de LilleLille, FranceNo longer taking part
- Hôpital Nord Franche-ComtéMontbéliard, FranceNo longer taking part
- CHU de Reims Hôpital Robert DebréReims, FranceNo longer taking part
- Centre Paul StraussStrasbourg, FranceNo longer taking part
- Clinique Sainte AnneStrasbourg, FranceNo longer taking part
- CHU de ToursTours, FranceNo longer taking part
Trial details
- Who runs it
- Centre Hospitalier Universitaire de Besancon
- Trial code
- NCT03117972
- Record updated
- 5 February 2025
- Original description
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.Read full original descriptionShow less
Chemotherapy Intensification in Patients With High Lactate Dehydrogenase Values and Soluble Syndecan-1 Levels
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.
Inclusion: 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: Previous treatment (chemotherapy, targeted therapy, surgery) for metastatic disease; Bevacizumab contraindication; 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; 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; Brain metastases; Pregnancy, breast-feeding or absence of adequate contraception for fertile patients; Patient under guardianship, curator or under the protection of justice.