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

NCT03117972 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2025-02-05

No results posted yet for this study

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.

Conditions

Interventions

DRUG

FOLFOXIRI

12 cycles

DRUG

FOLFOX

12 cycles

DRUG

FOLFIRI

12 cycles

DRUG

Bevacizumab

12 cycles

DRUG

LV5FU2

Maintenance chemotherapy

DRUG

Capecitabine

Maintenance chemotherapy

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Besancon

    lead OTHER

Principal Investigators

  • Christophe BORG, Pr · Centre Hospitalier Universitaire de Besançon

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
76 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-04
Primary Completion
2024-08-07
Completion
2024-11-18

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03117972 on ClinicalTrials.gov