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Trial record 1 of 1 for:    nct 03117972
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Chemotherapy Intensification in Patients With High Lactate Dehydrogenase Values and Soluble Syndecan1 Levels (CLavSyn)

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ClinicalTrials.gov Identifier: NCT03117972
Recruitment Status : Active, not recruiting
First Posted : April 18, 2017
Last Update Posted : December 22, 2023
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

Study Description
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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.


Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: FOLFOXIRI Drug: FOLFOX Drug: FOLFIRI Drug: Bevacizumab Drug: LV5FU2 Drug: Capecitabine Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 177 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Chemotherapy Intensification in Patients With High Lactate Dehydrogenase Values and Soluble Syndecan-1 Levels
Actual Study Start Date : August 4, 2017
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2025
Arms and Interventions
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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:
  • Irinotecan
  • Oxaliplatin
  • Leucovorin
  • 5-Fluorouracil

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: FOLFOX
12 cycles
Other Names:
  • Oxaliplatin
  • 5-Fluorouracil

Drug: FOLFIRI
12 cycles
Other Names:
  • Ironotecan
  • Leucovorin
  • 5-Fluorouracil

Drug: Bevacizumab
12 cycles

Drug: LV5FU2
Maintenance chemotherapy

Drug: Capecitabine
Maintenance chemotherapy


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 76 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03117972


Locations
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France
Centre Hospitalier Universitaire de Besançon
Besançon, France, 25000
Centre Hospitalier de Boulogne sur Mer
Boulogne-sur-Mer, France
CH de Colmar
Colmar, France
Institut de Cancérologie de Bourgogne
Dijon, France, 21000
CHRU de LILLE
Lille, France, 59037
Hôpital Nord Franche-Comté
Montbéliard, France, 25209
CHU de REIMS, Hôpital Robert Debré
Reims, France
Clinique Sainte Anne
Strasbourg, France, 67000
Centre Paul Strauss
Strasbourg, France, 67065
CHU de Tours
Tours, France, 37044
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Investigators
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Principal Investigator: Christophe BORG, Pr Centre Hospitalier Universitaire de Besançon
More Information
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Publications:

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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT03117972    
Other Study ID Numbers: API/2016/73
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: December 22, 2023
Last Verified: December 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Besancon:
Metastatic colorectal cancer
Biomarker
Chemotherapy intensification
 Syndecan1
LDH
CD138
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Leucovorin
Bevacizumab
Capecitabine
Fluorouracil
 Oxaliplatin
Irinotecan
Levoleucovorin
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors