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

Metastatic Colorectal Cancer Clinical Trial

— CLavSyn  

Official title:

Chemotherapy Intensification in Patients With High Lactate Dehydrogenase Values and Soluble Syndecan-1 Levels

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03117972
• Other study ID #: API/2016/73
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: August 4, 2017
• Est. completion date: December 2025

Study information

• Verified date: December 2023
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 177
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 76 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Drug:
• FOLFOXIRI
12 cycles
• FOLFOX
12 cycles
• FOLFIRI
12 cycles
• Bevacizumab
12 cycles
• LV5FU2
Maintenance chemotherapy
• Capecitabine
Maintenance chemotherapy

Locations

Country	Name	City	State
France	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	Centre Paul Strauss	Strasbourg
France	Clinique Sainte Anne	Strasbourg
France	CHU de Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival	Delay from the date of randomization to the disease progression (RECIST) or death from any cause whichever occurs first	up to 4 years (3 years of inclusion and 12 months of follow up after the last patient included)