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

February 4, 2025 updated by: Centre Hospitalier Universitaire de Besançon

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besançon, France, 25000
        • Centre Hospitalier Universitaire de Besancon
      • Boulogne-sur-Mer, France
        • Centre Hospitalier de Boulogne Sur Mer
      • Colmar, France
        • CH de COLMAR
      • Dijon, France, 21000
        • Institut de Cancerologie de Bourgogne
      • Lille, France, 59037
        • CHRU de Lille
      • Montbéliard, France, 25209
        • Hôpital Nord Franche-Comté
      • Reims, France
        • CHU de Reims, Hôpital Robert Debré
      • Strasbourg, France, 67000
        • Clinique Sainte Anne
      • Strasbourg, France, 67065
        • Centre Paul Strauss
      • Tours, France, 37044
        • Chu De Tours

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A : FOLFOXIRI - bevacizumab
FOLFOXIRI + bevacizumab, 12 cures following by maintenance chemotherapy (bevacizumab + LV5FU2 or bevacizumab-capecitabine) until disease progression or limiting toxicities
Drug: FOLFOXIRI
12 cycles
Other Names:
  • Leucovorin
  • Irinotecan
  • 5-Fluorouracil
  • Oxaliplatin
Drug: Bevacizumab
12 cycles
Drug: LV5FU2
Maintenance chemotherapy
Drug: Capecitabine
Maintenance chemotherapy
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
Drug: Bevacizumab
12 cycles
Drug: LV5FU2
Maintenance chemotherapy
Drug: Capecitabine
Maintenance chemotherapy
Drug: FOLFOX
12 cycles
Other Names:
  • 5-Fluorouracil
  • Oxaliplatin
Drug: FOLFIRI
12 cycles
Other Names:
  • Leucovorin
  • 5-Fluorouracil
  • Ironotecan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival
Time Frame: up to 4 years (3 years of inclusion and 12 months of follow up after the last patient included)
Delay from the date of randomization to the disease progression (RECIST) or death from any cause whichever occurs first
up to 4 years (3 years of inclusion and 12 months of follow up after the last patient included)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besançon

Investigators

  • Principal Investigator: Christophe BORG, Pr, Centre Hospitalier Universitaire de Besancon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 4, 2017

Primary Completion (Actual)

August 7, 2024

Study Completion (Actual)

November 18, 2024

Study Registration Dates

First Submitted

April 13, 2017

First Submitted That Met QC Criteria

April 13, 2017

First Posted (Actual)

April 18, 2017

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 4, 2025

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • API/2016/73

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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