Chemotherapy Intensification in Patients With High Lactate Dehydrogenase Values and Soluble Syndecan1 Levels
NCT ID: NCT03117972
Last Updated: 2025-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
54 participants
INTERVENTIONAL
2017-08-04
2024-11-18
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A : FOLFOXIRI - bevacizumab
FOLFOXIRI + bevacizumab, 12 cures following by maintenance chemotherapy (bevacizumab + LV5FU2 or bevacizumab-capecitabine) until disease progression or limiting toxicities
FOLFOXIRI
12 cycles
Bevacizumab
12 cycles
LV5FU2
Maintenance chemotherapy
Capecitabine
Maintenance chemotherapy
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
FOLFOX
12 cycles
FOLFIRI
12 cycles
Bevacizumab
12 cycles
LV5FU2
Maintenance chemotherapy
Capecitabine
Maintenance chemotherapy
Interventions
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FOLFOXIRI
12 cycles
FOLFOX
12 cycles
FOLFIRI
12 cycles
Bevacizumab
12 cycles
LV5FU2
Maintenance chemotherapy
Capecitabine
Maintenance chemotherapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically proved metastatic colorectal adenocarcinoma, with non-resectable metastases
* Adequate hematological, hepatic, and renal functions
* Signed written informed consent
Exclusion Criteria
* 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.
18 Years
76 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Besancon
OTHER
Responsible Party
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Principal Investigators
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Christophe BORG, Pr
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Universitaire de Besançon
Locations
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Centre Hospitalier Universitaire de Besançon
Besançon, , France
Centre Hospitalier de Boulogne sur Mer
Boulogne-sur-Mer, , France
CH de Colmar
Colmar, , France
Institut de Cancérologie de Bourgogne
Dijon, , France
CHRU de LILLE
Lille, , France
Hôpital Nord Franche-Comté
Montbéliard, , France
CHU de REIMS, Hôpital Robert Debré
Reims, , France
Clinique Sainte Anne
Strasbourg, , France
Centre Paul Strauss
Strasbourg, , France
CHU de Tours
Tours, , France
Countries
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References
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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.
Other Identifiers
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API/2016/73
Identifier Type: -
Identifier Source: org_study_id
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