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

Sponsor
Centre Hospitalier Universitaire de Besancon
Study ID
NCT03117972
Phase
PHASE2
Status
Terminated

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 76 Years
Healthy Volunteers
Not accepted

Interventions

  • FOLFOXIRI — DRUG
    12 cycles
  • FOLFOX — DRUG
    12 cycles
  • FOLFIRI — DRUG
    12 cycles
  • Bevacizumab — DRUG
    12 cycles
  • LV5FU2 — DRUG
    Maintenance chemotherapy
  • Capecitabine — DRUG
    Maintenance chemotherapy

Study Details

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.

Key Dates

First listed
Apr 18, 2017
Start date
Aug 4, 2017
Status verified
Feb 2024
Primary completion
Aug 7, 2024
Completion
Nov 18, 2024

Study Design

Enrollment
54 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A : FOLFOXIRI - bevacizumab
    FOLFOXIRI + bevacizumab, 12 cures following by maintenance chemotherapy (bevacizumab + LV5FU2 or bevacizumab-capecitabine) until disease progression or limiting toxicities
  • Active Comparator: Arm B: FOLFOX or FOLFIRI - bevacizumab
    FOLFOX or FOLFIRI + bevacizumab 12 cures following by maintenance chemotherapy (bevacizumab + LV5FU2 ou bevacizumab capecitabine) until disease progression or limiting toxicities

Primary Outcome Measure

Progression Free Survival [ Time Frame: up to 4 years (3 years of inclusion and 12 months of follow up after the last patient included) ]

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