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

  • STATUS
    Recruiting
  • End date
    Oct 3, 2023
  • participants needed
    177
  • sponsor
    Centre Hospitalier Universitaire de Besancon
Updated on 3 August 2021
oxaliplatin
capecitabine
irinotecan
bevacizumab
folfox regimen
adenocarcinoma
folfiri regimen
colorectal adenocarcinoma
metastatic colorectal adenocarcinoma
folfoxiri

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.

Details
Condition Metastatic Colorectal Cancer
Treatment Capecitabine, bevacizumab, FOLFIRI, FOLFOX, FOLFOXIRI, LV5FU2
Clinical Study IdentifierNCT03117972
SponsorCentre Hospitalier Universitaire de Besancon
Last Modified on3 August 2021

Eligibility

Yes No Not Sure

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
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