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

Phase 2

Terminated

• Conditions: Metastatic Colorectal Cancer
• Interventions: Drug: FOLFOXIRI; Drug: FOLFOX; Drug: FOLFIRI; Drug: LV5FU2; Drug: Bevacizumab; Drug: Capecitabine

• Registration Number: NCT03117972
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2017-04-13
• Study First Submitted QC: 2017-04-13
• Study First Posted: 2017-04-18
• Study Start: 2017-08-04
• Primary Completion: 2024-08-07
• Study Completion: 2024-08-07
• Status Verified: 2024-11
• Last Update Submitted: 2024-12-19
• Last Update Posted: 2024-12-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 54

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A : FOLFOXIRI - bevacizumab	LV5FU2	FOLFOXIRI + bevacizumab, 12 cures following by maintenance chemotherapy (bevacizumab + LV5FU2 or bevacizumab-capecitabine) until disease progression or limiting toxicities
Arm A : FOLFOXIRI - bevacizumab	FOLFOXIRI	FOLFOXIRI + bevacizumab, 12 cures following by maintenance chemotherapy (bevacizumab + LV5FU2 or bevacizumab-capecitabine) until disease progression or limiting toxicities
Arm B: FOLFOX or FOLFIRI - bevacizumab	FOLFOX	FOLFOX or FOLFIRI + bevacizumab 12 cures following by maintenance chemotherapy (bevacizumab + LV5FU2 ou bevacizumab capecitabine) until disease progression or limiting toxicities
Arm B: FOLFOX or FOLFIRI - bevacizumab	FOLFIRI	FOLFOX or FOLFIRI + bevacizumab 12 cures following by maintenance chemotherapy (bevacizumab + LV5FU2 ou bevacizumab capecitabine) until disease progression or limiting toxicities
Arm B: FOLFOX or FOLFIRI - bevacizumab	Bevacizumab	FOLFOX or FOLFIRI + bevacizumab 12 cures following by maintenance chemotherapy (bevacizumab + LV5FU2 ou bevacizumab capecitabine) until disease progression or limiting toxicities
Arm B: FOLFOX or FOLFIRI - bevacizumab	LV5FU2	FOLFOX or FOLFIRI + bevacizumab 12 cures following by maintenance chemotherapy (bevacizumab + LV5FU2 ou bevacizumab capecitabine) until disease progression or limiting toxicities
Arm B: FOLFOX or FOLFIRI - bevacizumab	Capecitabine	FOLFOX or FOLFIRI + bevacizumab 12 cures following by maintenance chemotherapy (bevacizumab + LV5FU2 ou bevacizumab capecitabine) until disease progression or limiting toxicities
Arm A : FOLFOXIRI - bevacizumab	Bevacizumab	FOLFOXIRI + bevacizumab, 12 cures following by maintenance chemotherapy (bevacizumab + LV5FU2 or bevacizumab-capecitabine) until disease progression or limiting toxicities
Arm A : FOLFOXIRI - bevacizumab	Capecitabine	FOLFOXIRI + bevacizumab, 12 cures following by maintenance chemotherapy (bevacizumab + LV5FU2 or bevacizumab-capecitabine) until disease progression or limiting toxicities

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	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

Trial Locations

Locations (10)

CHU de REIMS, Hôpital Robert Debré; 🇫🇷 Reims, France

Centre Hospitalier Universitaire de Besançon; 🇫🇷 Besançon, France

Centre Hospitalier de Boulogne sur Mer; 🇫🇷 Boulogne-sur-Mer, France

CH de Colmar; 🇫🇷 Colmar, France

CHRU de LILLE; 🇫🇷 Lille, France

Centre Paul Strauss; 🇫🇷 Strasbourg, France

Clinique Sainte Anne; 🇫🇷 Strasbourg, France

CHU de Tours; 🇫🇷 Tours, France

Institut de Cancérologie de Bourgogne; 🇫🇷 Dijon, France

Hôpital Nord Franche-Comté; 🇫🇷 Montbéliard, France