Metastatic Colorectal CancerPhase 2CLavSynNCT03117972
Chemotherapy Intensification in Patients With High Lactate Dehydrogenase Values and Soluble Syndecan1 Levels
A Phase 2 study testing FOLFOXIRI, FOLFOX and FOLFIRI in people with Metastatic Colorectal Cancer, run by Centre Hospitalier Universitaire de Besancon at 10 sites in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 76 years
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- FOLFOXIRI, FOLFOX and FOLFIRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 10 sitesFrance
- Study dates
- 4 Aug 2017to 18 Nov 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
Centre Hospitalier Universitaire de Besançon
Besançon, 25000
Centre Hospitalier de Boulogne sur Mer
Boulogne-sur-Mer
CH de Colmar
Colmar
Institut de Cancérologie de Bourgogne
Dijon, 21000
CHRU de LILLE
Lille, 59037
Hôpital Nord Franche-Comté
Montbéliard, 25209
CHU de REIMS, Hôpital Robert Debré
Reims
Clinique Sainte Anne
Strasbourg, 67000
Centre Paul Strauss
Strasbourg, 67065
CHU de Tours
Tours, 37044
About this study
Official title: Chemotherapy Intensification in Patients With High Lactate Dehydrogenase Values and Soluble Syndecan-1 Levels
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.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- FOLFOXIRI, FOLFOX, FOLFIRI, Bevacizumab, LV5FU2
- Keywords
- Metastatic colorectal cancer, Biomarker, Chemotherapy intensification, Syndecan1, LDH, CD138
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOLFOXIRIDrug
Also called Irinotecan, Oxaliplatin, Leucovorin, 5-Fluorouracil
12 cycles
FOLFOXDrug
Also called Oxaliplatin, 5-Fluorouracil
12 cycles
FOLFIRIDrug
Also called Ironotecan, Leucovorin, 5-Fluorouracil
12 cycles
BevacizumabDrug
12 cycles
LV5FU2Drug
Maintenance chemotherapy
CapecitabineDrug
Maintenance chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Arm A : FOLFOXIRI - bevacizumab | Experimental | FOLFOXIRI + bevacizumab, 12 cures following by maintenance chemotherapy (bevacizumab + LV5FU2 or bevacizumab-capecitabine) until disease progression or limiting toxicities Receives: Drug: FOLFOXIRI; Drug: Bevacizumab; Drug: LV5FU2; Drug: Capecitabine |
| Arm B: FOLFOX or FOLFIRI - bevacizumab | Active comparator | FOLFOX or FOLFIRI + bevacizumab 12 cures following by maintenance chemotherapy (bevacizumab + LV5FU2 ou bevacizumab capecitabine) until disease progression or limiting toxicities Receives: Drug: FOLFOX; Drug: FOLFIRI; Drug: Bevacizumab; Drug: LV5FU2; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Delay from the date of randomization to the disease progression (RECIST) or death from any cause whichever occurs first
Measured: up to 4 years (3 years of inclusion and 12 months of follow up after the last patient included)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start4 Aug 2017
- Primary completion7 Aug 2024
- Study completion18 Nov 2024
Why it stopped: enrollment too slow
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christophe BORG, Pr, Principal investigator, Centre Hospitalier Universitaire de Besancon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03117972
- Sponsor's protocol ID
- API/2016/73
- Acronym
- CLavSyn
- Status last verified
- Feb 2024
- First submitted
- 13 Apr 2017
- Last updated
- 5 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27472156
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemotherapy Intensification in Patients With High Lactate Dehydrogenase Values and Soluble Syndecan-1 Levels
- ClinicalTrials.gov ID
- NCT03117972
- Acronym / sponsor ID
- CLavSyn / API/2016/73
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- Metastatic colorectal cancer, Biomarker, Chemotherapy intensification, Syndecan1, LDH, CD138
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: enrollment too slow
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 4 Aug 2017 (actual)
- Primary completion
- 7 Aug 2024 (actual)
- Study completion
- 18 Nov 2024 (actual)
- First posted
- 18 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A : FOLFOXIRI - bevacizumab | Experimental | Drug: FOLFOXIRI, Drug: Bevacizumab, Drug: LV5FU2, Drug: CapecitabineFOLFOXIRI + bevacizumab, 12 cures following by maintenance chemotherapy (bevacizumab + LV5FU2 or bevacizumab-capecitabine) until disease progression or limiting toxicities |
| Arm B: FOLFOX or FOLFIRI - bevacizumab | Active comparator | Drug: FOLFOX, Drug: FOLFIRI, Drug: Bevacizumab, Drug: LV5FU2, Drug: CapecitabineFOLFOX or FOLFIRI + bevacizumab 12 cures following by maintenance chemotherapy (bevacizumab + LV5FU2 ou bevacizumab capecitabine) until disease progression or limiting toxicities |
Who may qualify
- Ages
- 18 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FOLFOXIRIAlso: Irinotecan, Oxaliplatin, Leucovorin, 5-Fluorouracil12 cycles | Drug | Arm A : FOLFOXIRI - bevacizumab |
| FOLFOXAlso: Oxaliplatin, 5-Fluorouracil12 cycles | Drug | Arm B: FOLFOX or FOLFIRI - bevacizumab |
| FOLFIRIAlso: Ironotecan, Leucovorin, 5-Fluorouracil12 cycles | Drug | Arm B: FOLFOX or FOLFIRI - bevacizumab |
| Bevacizumab12 cycles | Drug | Arm A : FOLFOXIRI - bevacizumab, Arm B: FOLFOX or FOLFIRI - bevacizumab |
| LV5FU2Maintenance chemotherapy | Drug | Arm A : FOLFOXIRI - bevacizumab, Arm B: FOLFOX or FOLFIRI - bevacizumab |
| CapecitabineMaintenance chemotherapy | Drug | Arm A : FOLFOXIRI - bevacizumab, Arm B: FOLFOX or FOLFIRI - bevacizumab |
Primary outcome
Progression Free Survival
Time frame: 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
Results and safety
The study was stopped early (reason given: enrollment too slow). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Background: PubMed 27472156Jary 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christophe BORG, Pr principal investigator
Centre Hospitalier Universitaire de Besancon
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FOLFOXIRI, FOLFOX and FOLFIRI in people with Metastatic Colorectal Cancer, run by Centre Hospitalier Universitaire de Besancon at 10 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: enrollment too slow). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: up to 4 years (3 years of inclusion and 12 months of follow up after the last patient included)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03117972, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.