Clinical trial NCT03117972: Chemotherapy Intensification in Patients With High Lactate Dehydrogenase Values and Soluble Syndecan1 Levels
Official title: Chemotherapy Intensification in Patients With High Lactate Dehydrogenase Values and Soluble Syndecan-1 Levels
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Metastatic Colorectal Cancer
Keywords: Metastatic colorectal cancer
Biomarker
Chemotherapy intensification
Syndecan1
LDH
CD138
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2017-04-18
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Progression Free Survival
timeFrame: up to 4 years (3 years of inclusion and 12 months of follow up after the last patient included)
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: Centre Hospitalier Universitaire de Besançon
city: Boulogne-sur-Mer
country: France
facility: Centre Hospitalier de Boulogne sur Mer
city: Colmar
country: France
facility: CH de Colmar
city: Dijon
country: France
facility: Institut de Cancérologie de Bourgogne
city: Lille
country: France
facility: CHRU de LILLE
city: Montbéliard
country: France
facility: Hôpital Nord Franche-Comté
city: Reims
country: France
facility: CHU de REIMS, Hôpital Robert Debré
city: Strasbourg
country: France
facility: Clinique Sainte Anne
city: Strasbourg
country: France
facility: Centre Paul Strauss
city: Tours
country: France
facility: CHU de Tours
Study officials:
affiliation: Centre Hospitalier Universitaire de Besançon
name: Christophe BORG, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jary M, Lecomte T, Bouche O, Kim S, Dobi E, Queiroz L, Ghiringhelli F, Etienne H, Leger J, Godet Y, Balland J, Lakkis Z, Adotevi O, Bonnetain F, Borg C, Vernerey D. Prognostic value of baseline seric Syndecan-1 in initially unresectable metastatic colorectal cancer patients: a simple biological score. Int J Cancer. 2016 Nov 15;139(10):2325-35. doi: 10.1002/ijc.30367. Epub 2016 Aug 13.