Chemotherapy Intensification in Patients With High Lactate Dehydrogenase Values and Soluble Syndecan1 Levels (CLavSyn)
Primary Purpose
Metastatic Colorectal Cancer
Status
Recruiting
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
FOLFOXIRI
FOLFOX
FOLFIRI
Bevacizumab
LV5FU2
Capecitabine
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring Metastatic colorectal cancer, Biomarker, Chemotherapy intensification, Syndecan1, LDH, CD138
Eligibility 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.
Sites / Locations
- Centre Hospitalier Universitaire de BesançonRecruiting
- Centre Hospitalier de Boulogne sur MerRecruiting
- CH de ColmarRecruiting
- Institut de Cancérologie de BourgogneRecruiting
- CHRU de LILLERecruiting
- Hôpital Nord Franche-ComtéRecruiting
- Institut de Cancérolgie de Montpellier- ICM
- CHU de REIMS, Hôpital Robert DebréRecruiting
- Clinique Sainte AnneRecruiting
- Centre Paul StraussRecruiting
- CHU de ToursRecruiting
- CHI de Haute-Saône
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm A : FOLFOXIRI - bevacizumab
Arm B: FOLFOX or FOLFIRI - bevacizumab
Arm Description
FOLFOXIRI + bevacizumab, 12 cures following by maintenance chemotherapy (bevacizumab + LV5FU2 or bevacizumab-capecitabine) until disease progression or limiting toxicities
FOLFOX or FOLFIRI + bevacizumab 12 cures following by maintenance chemotherapy (bevacizumab + LV5FU2 ou bevacizumab capecitabine) until disease progression or limiting toxicities
Outcomes
Primary Outcome Measures
Progression Free Survival
Delay from the date of randomization to the disease progression (RECIST) or death from any cause whichever occurs first
Secondary Outcome Measures
Full Information
NCT ID
NCT03117972
First Posted
April 13, 2017
Last Updated
November 17, 2022
Sponsor
Centre Hospitalier Universitaire de Besancon
1. Study Identification
Unique Protocol Identification Number
NCT03117972
Brief Title
Chemotherapy Intensification in Patients With High Lactate Dehydrogenase Values and Soluble Syndecan1 Levels
Acronym
CLavSyn
Official Title
Chemotherapy Intensification in Patients With High Lactate Dehydrogenase Values and Soluble Syndecan-1 Levels
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 4, 2017 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer
Keywords
Metastatic colorectal cancer, Biomarker, Chemotherapy intensification, Syndecan1, LDH, CD138
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
177 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm A : FOLFOXIRI - bevacizumab
Arm Type
Experimental
Arm Description
FOLFOXIRI + bevacizumab, 12 cures following by maintenance chemotherapy (bevacizumab + LV5FU2 or bevacizumab-capecitabine) until disease progression or limiting toxicities
Arm Title
Arm B: FOLFOX or FOLFIRI - bevacizumab
Arm Type
Active Comparator
Arm Description
FOLFOX or FOLFIRI + bevacizumab 12 cures following by maintenance chemotherapy (bevacizumab + LV5FU2 ou bevacizumab capecitabine) until disease progression or limiting toxicities
Intervention Type
Drug
Intervention Name(s)
FOLFOXIRI
Other Intervention Name(s)
Irinotecan, Oxaliplatin, Leucovorin, 5-Fluorouracil
Intervention Description
12 cycles
Intervention Type
Drug
Intervention Name(s)
FOLFOX
Other Intervention Name(s)
Oxaliplatin, 5-Fluorouracil
Intervention Description
12 cycles
Intervention Type
Drug
Intervention Name(s)
FOLFIRI
Other Intervention Name(s)
Ironotecan, Leucovorin, 5-Fluorouracil
Intervention Description
12 cycles
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Intervention Description
12 cycles
Intervention Type
Drug
Intervention Name(s)
LV5FU2
Intervention Description
Maintenance chemotherapy
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Description
Maintenance chemotherapy
Primary Outcome Measure Information:
Title
Progression Free Survival
Description
Delay from the date of randomization to the disease progression (RECIST) or death from any cause whichever occurs first
Time Frame
up to 4 years (3 years of inclusion and 12 months of follow up after the last patient included)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
76 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christophe BORG, Pr
Phone
03 81 66 81 66
Email
christophe.borg@efs.sante.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christophe BORG, Pr
Organizational Affiliation
Centre Hospitalier Universitaire de Besançon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire de Besançon
City
Besançon
ZIP/Postal Code
25000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angélique VIENOT, Dr
Facility Name
Centre Hospitalier de Boulogne sur Mer
City
Boulogne-sur-Mer
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent BOURGEOIS, Dr
Facility Name
CH de Colmar
City
Colmar
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cynthia REICHLING, Dr
Facility Name
Institut de Cancérologie de Bourgogne
City
Dijon
ZIP/Postal Code
21000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ariane Darut-Jouve, Dr
Facility Name
CHRU de LILLE
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony TURPIN, Dr
Facility Name
Hôpital Nord Franche-Comté
City
Montbéliard
ZIP/Postal Code
25209
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe BORG, Pr
Facility Name
Institut de Cancérolgie de Montpellier- ICM
City
Montpellier
ZIP/Postal Code
34070
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmanuelle SAMALIN, Dr
Facility Name
CHU de REIMS, Hôpital Robert Debré
City
Reims
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier BOUCHE, Pr
Facility Name
Clinique Sainte Anne
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Louis-Marie Dourthe, Dr
Facility Name
Centre Paul Strauss
City
Strasbourg
ZIP/Postal Code
67065
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meher Benabdelghani, Dr
Facility Name
CHU de Tours
City
Tours
ZIP/Postal Code
37044
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thierry Lecomte, Pr
Facility Name
CHI de Haute-Saône
City
Vesoul
ZIP/Postal Code
70014
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denis Cleau, Dr
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27472156
Citation
Jary M, Lecomte T, Bouche O, Kim S, Dobi E, Queiroz L, Ghiringhelli F, Etienne H, Leger J, Godet Y, Balland J, Lakkis Z, Adotevi O, Bonnetain F, Borg C, Vernerey D. Prognostic value of baseline seric Syndecan-1 in initially unresectable metastatic colorectal cancer patients: a simple biological score. Int J Cancer. 2016 Nov 15;139(10):2325-35. doi: 10.1002/ijc.30367. Epub 2016 Aug 13.
Results Reference
background
Learn more about this trial
Chemotherapy Intensification in Patients With High Lactate Dehydrogenase Values and Soluble Syndecan1 Levels
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