Chemotherapy Intensification in Patients With High Lactate Dehydrogenase Values and Soluble Syndecan1 Levels (CLavSyn)

Centre Hospitalier Universitaire de Besancon

Status and phase: Terminated; Phase 2

Conditions: Metastatic Colorectal Cancer

Treatments: Drug: FOLFIRI; Drug: FOLFOX; Drug: LV5FU2; Drug: Bevacizumab; Drug: Capecitabine; Drug: FOLFOXIRI

Study type: Interventional

Funder types: Other

Identifiers

NCT03117972

API/2016/73

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: All

Ages: 18 to 76 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 2 patient groups

Arm A : FOLFOXIRI - bevacizumab

Experimental group

Description:

FOLFOXIRI + bevacizumab, 12 cures following by maintenance chemotherapy (bevacizumab + LV5FU2 or bevacizumab-capecitabine) until disease progression or limiting toxicities

Treatment:

Drug: FOLFOXIRI

Drug: Capecitabine

Drug: Bevacizumab

Drug: LV5FU2

Arm B: FOLFOX or FOLFIRI - bevacizumab

Active Comparator group

Description:

FOLFOX or FOLFIRI + bevacizumab 12 cures following by maintenance chemotherapy (bevacizumab + LV5FU2 ou bevacizumab capecitabine) until disease progression or limiting toxicities

Treatment:

Drug: Capecitabine

Drug: Bevacizumab

Drug: LV5FU2

Drug: FOLFIRI

Drug: FOLFOX