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Trial record 87 of 159 for:    colon cancer AND Capecitabine AND Fluorouracil

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

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ClinicalTrials.gov Identifier: NCT03117972
Recruitment Status : Recruiting
First Posted : April 18, 2017
Last Update Posted : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

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

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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 : April 2021
Estimated Study Completion Date : October 2021

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




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



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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.

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


Contacts
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Contact: Marine JARY, Dr 03 81 66 81 66 mjary@chu-besancon.fr
Contact: Christophe BORG, Pr 03 81 66 81 66 christophe.borg@efs.sante.fr

Locations
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France
Centre Hospitalier Universitaire de Besançon Recruiting
Besançon, France, 25000
Contact: Marine JARY, PH         
Centre Hospitalier de Boulogne sur Mer Recruiting
Boulogne-sur-Mer, France
Contact: Vincent BOURGEOIS, Dr         
CH de Colmar Recruiting
Colmar, France
Principal Investigator: Gilles BREYSACHER, Dr         
Institut de Cancérologie de Bourgogne Recruiting
Dijon, France, 21000
Contact: Ariane Darut-Jouve, Dr         
CHRU de LILLE Recruiting
Lille, France, 59037
Contact: Anthony TURPIN, Dr         
Hôpital Nord Franche-Comté Recruiting
Montbéliard, France, 25209
Contact: Stefano Kim, Dr         
Institut de Cancérolgie de Montpellier- ICM Not yet recruiting
Montpellier, France, 34070
Contact: Emmanuelle SAMALIN, Dr         
CHU de REIMS, Hôpital Robert Debré Recruiting
Reims, France
Contact: Olivier BOUCHE, Pr         
Clinique Sainte Anne Recruiting
Strasbourg, France, 67000
Contact: Louis-Marie Dourthe, Dr         
Centre Paul Strauss Recruiting
Strasbourg, France, 67065
Contact: Meher Benabdelghani, Dr         
CHU de Tours Recruiting
Tours, France, 37044
Contact: Thierry Lecomte, Pr         
CHI de Haute-Saône Not yet recruiting
Vesoul, France, 70014
Contact: Denis Cleau, Dr         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Investigators
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Principal Investigator: Marine JARY, Dr Centre Hospitalier Universitaire de Besançon

Publications:
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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT03117972     History of Changes
Other Study ID Numbers: API/2016/73
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019

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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
Colonic Diseases
Capecitabine
Fluorouracil
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Bevacizumab
Oxaliplatin
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